Rucker’s Makin’ Batch Candies Issues Food Recall of Dark Chocolate Coffee Beans, Dark Chocolate Cranberries and Dark Chocolate Peanuts – Because of Possible Health Risk, Due to Undeclared Milk Allergen - FDA Safety Alerts & Drug Recalls

Rucker’s Makin’ Batch Candies, Inc. of Bridgeport, IL is voluntarily recalling the specific code dates listed below of The Toothsome Chocolate Emporium Dark Chocolate Coffee Beans, due to an undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergen run the risk of serious or life threatening allergic reaction if they consume this product. No illness has been reported to date.

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Rucker’s Wholesale and Service Co Issues Allergy Alert For Undeclared Milk In Dark Chocolate Peanuts Received From Our Supplier GKI Foods LLC. - FDA Safety Alerts & Drug Recalls

Rucker’s Wholesale and Service Co of Bridgeport, IL is voluntarily recalling all of Uncle Buck’s and Family Choice Dark Chocolate Peanuts packaged in standup twist tie bag, due to the presence of an undeclared milk ingredient. People who have an allergy or sensitivity to milk run the risk of serious or life threatening allergic reaction if they consume this product. No illness associated with this recall has been reported.

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Allergy Alert Issued in Five Northern California Whole Foods Market Stores for Undeclared Walnuts in Pumpkin Drop Cookies - FDA Safety Alerts & Drug Recalls

Five Whole Foods Market stores in Northern California are voluntarily recalling frosted Pumpkin Drop cookies because the products contained tree nut allergens (walnuts) that were not listed on the product label. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reactions if they consume these products.

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21st Century Snack Foods is Voluntarily Recalling Dark Chocolate Almonds Due to Possible Undeclared Milk Allergen - FDA Safety Alerts & Drug Recalls

21st Century Snack Foods, of Ronkonkoma NY 11779, is voluntarily issuing the following recall: Dark Chocolate Almonds packaged in a 6 oz peg / stand up bag. UPC# 030603 228549. Affected Lot #’s are 16100 thru 17300. The product brand is 21st Century Snack Foods.

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FDA approves new treatment for adults with mantle cell lymphoma - FDA Press Releases

The U.S. Food and Drug Administration today granted accelerated approval to Calquence (acalabrutinib) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.

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FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections - FDA Press Releases

The U.S. Food and Drug Administration has determined the agency will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.

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Haig’s Delicacies LLC Recalls Lot of Taboule Salad Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Haig’s Delicacies of Hayward, CA is recalling 342 cases of Taboule Salad because it may be contaminated with Escherichia coli O157:H7 bacteria (E. Coli O157:H7). E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely within a week, some people can develop a form of kidney failure called Hemolytic Uremic Syndrome (HUS).

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Erratum - American Geriatric Society

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new strategies for addressing the crisis of opioid addiction through innovation in packaging, storage and disposal - FDA Press Releases

Statement by FDA Commissioner Gottlieb on new strategies for addressing the opioid addiction crisis.

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Meijer Recalls Select Meijer Bulk Dark Chocolate Products Due to Possible Undeclared Milk Allergen - FDA Safety Alerts & Drug Recalls

In cooperation with the GKI Foods LLC recall of dark chocolate products due to an undeclared milk allergen, Meijer is voluntarily recalling select Meijer branded bulk dark chocolate. This recall is an extension of the GKI Foods LLC recall announced on October 27, 2017. People who have an allergy or severe sensitivity to milk run the risk of a serious or life threatening allergic reaction if they consume these products.

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First Source Issues Allergy Alert for Undeclared Milk in Several Dark Chocolate Products Received from our Supplier GKI Foods LLC - FDA Safety Alerts & Drug Recalls

First Source of Tonawanda, NY, is voluntarily recalling various packaged goods, as well as Products sold in grocery store bulk bins. All these products contain undeclared Milk. People who have an allergy or sensitivity to Milk run the risk of serious or life-threatening allergic reaction if they consume this product.

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Statement from Susan Mayne, Ph.D., on proposal to revoke health claim that soy protein reduces risk of heart disease - FDA Press Releases

Statement from Susan Mayne, Ph.D., on proposal to revoke health claim that soy protein reduces risk of heart disease

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Long Term Effect of Intensive Lifestyle Intervention on Cerebral Blood Flow - American Geriatric Society

Objectives

To determine whether long-term behavioral intervention targeting weight loss through increased physical activity and reduced caloric intake would alter cerebral blood flow (CBF) in individuals with type 2 diabetes mellitus.

Design

Postrandomization assessment of CBF.

Setting

Action for Health in Diabetes multicenter randomized controlled clinical trial.

Participants

Individuals with type 2 diabetes mellitus who were overweight or obese and aged 45 to 76 (N = 310).

Interventions

A multidomain intensive lifestyle intervention (ILI) to induce weight loss and increase physical activity for 8 to 11 years or diabetes support and education (DSE), a control condition.

Measurements

Participants underwent cognitive assessment and standardized brain magnetic resonance imaging (MRI) (3.0 Tesla) to assess CBF an average of 10.4 years after randomization.

Results

Weight changes from baseline to time of MRI averaged −6.2% for ILI and −2.8% for DSE (P < .001), and increases in self-reported moderate or intense physical activity averaged 444.3 kcal/wk for ILI and 114.8 kcal/wk for DSE (P = .03). Overall mean CBF was 6% greater for ILI than DSE (P = .04), with the largest mean differences between ILI and DSE in the limbic region (3.39 mL/100 g per minute, 95% confidence interval (CI) = 0.07–6.70 mL/100 g per minute) and occipital lobes (3.52 mL/100 g per minute, 95% CI = 0.20–6.84 mL/100 g per minute). In ILI, greater CBF was associated with greater decreases in weight and greater increases in physical activity. The relationship between CBF and scores on a composite measure of cognitive function varied between intervention groups (P = .02).

Conclusions

Long-term weight loss intervention in overweight and obese adults with type 2 diabetes mellitus is associated with greater CBF.

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Reply to: Comment on Tai Chi for Risk of Falls. A Meta-analysis - American Geriatric Society

This letter comments on the letter by Daniel et al.

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Comment on Tai Chi for Risk of Falls. A meta-analysis - American Geriatric Society

See the Reply by Lomas-Vega et al.

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GKI Foods LLC Issues Allergy Alert On Undeclared Milk In Dark Chocolate Products - FDA Safety Alerts & Drug Recalls

These products may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergen run the risk of serious or life threatening allergic reaction if they consume these products.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s important efforts to address the opioid crisis - FDA Press Releases

Today the Administration took a historic step to direct additional resources to help address the staggering human and economic toll created by the epidemic of opioid addiction.

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Medications That Cause Dry Mouth As an Adverse Effect in Older People: A Systematic Review and Metaanalysis - American Geriatric Society

Objectives

To assess and quantify the risk of drug-induced dry mouth as a side effect in older people.

Design

Systematic review and metaanalysis.

Setting

A search of the literature was undertaken using Medline, Embase, Cochrane, Web of Science, and PubMed from 1990 to 2016.

Participants

Older people (aged ≥60) who participated in intervention or observational studies investigating drug use as an exposure and xerostomia or salivary gland hypofunction as adverse drug outcomes.

Measurements

Two pairs of authors screened titles and abstracts of studies for relevance. Two authors independently extracted data, including study characteristics, definitions of exposure and outcome, and methodological quality. For the metaanalyses, random-effects models were used for pooling the data and I² statistics for exploring heterogeneity.

Results

Of 1,544 potentially relevant studies, 52 were deemed eligible for inclusion in the final review and 26 in metaanalyses. The majority of studies were of moderate methodological quality. In the intervention studies, urological medications (odds ratio (OR) = 5.91, 95% confidence interval (CI) = 4.04–8.63; I² = 62%), antidepressants (OR = 4.74, 95% CI = 2.69–8.32, I² = 21%), and psycholeptics (OR = 2.59, 95% CI = 1.79–3.95, I² = 0%) were significantly associated with dry mouth. In the observational studies, numbers of medications and several medication classes were significantly associated with xerostomia and salivary gland hypofunction.

Conclusion

Medication use was significantly associated with xerostomia and salivary gland hypofunction in older adults. The risk of dry mouth was greatest for drugs used for urinary incontinence. Future research should develop a risk score for medication-induced dry mouth to assist with prescribing and medication management.

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Men Lacking a Caregiver Have Greater Risk of Long-Term Nursing Home Placement After Stroke - American Geriatric Society

Background/Objectives

Social support can prevent or delay long-term nursing home placement (NHP). The purpose of our study was to understand how the availability of a caregiver can affect NHP after ischemic stroke and how this affects different subgroups differently.

Design

Nested cohort study.

Setting

Nationally based REasons for Geographic and Racial Differences in Stroke (REGARDS) study.

Participants

Stroke survivors aged 65 to 100 (256 men, 304 women).

Measurements

Data were from Medicare claims from January 2003 to December 2013 and REGARDS baseline interviews conducted from January 2003 to October 2007. Caregiver support was measured by asking, “If you had a serious illness or became disabled, do you have someone who would be able to provide care for you on an on-going basis?” Diagnosis of ischemic stroke was derived from inpatient claims. NHP was determined using a validated claims algorithm for stays of 100 days and longer. Risk was estimated using Cox regression.

Results

Within 5 years of stroke, 119 (21.3%) participants had been placed in a nursing home. Risk of NHP was greater in those lacking available caregivers (log-rank P = .006). After adjustment for covariates, lacking an available caregiver increased the risk of NHP after stroke within 1 year by 70% (hazard ratio (HR) = 1.70, 95% confidence interval (CI) = 0.97–2.99) and within 5 years by 68% (HR = 1.68, 95% CI = 1.10–2.58). The effect of caregiver availability on NHP within 5 years was limited to men (HR = 3.15, 95% CI = 1.49–6.67).

Conclusion

In men aged 65 and older who have survived an ischemic stroke, the lack of an available caregiver is associated with triple the risk of NHP within 5 years.

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Randalls, Tom Thumb and Albertsons stores in Texas, Louisiana and Arkansas Recall Ready. Chef. Go! Cod Fillet Seafood Meal Bag in Cooperation with Voluntary Recall by Mann Packing Due to Possible Listeria monocytogenes contamination - FDA Safety Alerts & Drug Recalls

In cooperation with the Mann Packing recall of minimally processed vegetable products due to possible Listeria monocytogenes contamination, Randalls, Tom Thumb and Albertsons stores in Texas, Louisiana and Arkansas only are voluntarily recalling the Ready. Chef. Go! Cod Filet seafood meal bag, which includes vegetables that are subject to the Mann Packing recall. This product is in addition to seafood meal bag products that were recalled

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Albertsons, Safeway, Vons and Pak N’ Save Stores in Eight States Revise Product Lists for Recall of Vegetable Trays and Cups in Cooperation with Mann Packing's Voluntary Recall Due to Possible Listeria monocytogenes Contamination - FDA Safety Alerts & Drug Recalls

Albertsons, Safeway, Vons and Pak N’ Save stores in eight states are revising a previously reported list of products that were voluntarily recalled in cooperation with Mann Packing’s recall of minimally processed vegetable products due to possible Listeria monocytogenes contamination.

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Cooperstown Cheese Company Recalls Cheese Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Cooperstown Cheese Company is voluntarily recalling Toma Celena, batch numbers 51017 & 52417, Roasted Garlic Cheddar batch numbers 52417 & 60717 and Roasted Garlic Peppercorn batch number 52417, for presumptive positive tests for Listeria. All package sizes are subject to the recall and the plant number on the label is 36-8524.

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Relish Foods, Inc. Recalls Frozen Tuna Loins Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

On October 13, 2017, Relish Foods, Inc. of Culver City, Calif., voluntarily initiated the recall of frozen Newport brand 5 to 8 lb. tuna loins. The recall has since expanded to include: 3 to 5 lb. tuna loins, 6 oz. tuna steaks, and 4 oz. tuna steaks. The recall is the result of sampling by the FDA which revealed that the product has potential to contain the bacteria Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. Relish Foods, Inc. is continuing the investigation with the FDA as to what caused the problem.

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Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives - FDA Press Releases

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Federal Efforts to Combat the Opioid Crisis: A Status Update on CARA and Other Initiatives

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Relationship Between Ideal Cardiovascular Health and Disability in Older Adults: The Chilean National Health Survey (2009–10) - American Geriatric Society

This study aimed to examine the relationship between disability and the American Heart Association metric of ideal cardiovascular health (CVH) in older adults from the 2009–10 Chilean National Health Survey. Data from 460 older adults were analyzed. All subjects were interviewed using the standardized World Health Survey, which includes 16 health-related questions and assesses the domains of mobility, self-care, pain and discomfort, cognition, interpersonal activities, vision, sleep and energy, and affect. A person who responds with a difficulty rating of severe, extreme, or unable to do in at least one of these eight functioning domains is considered to have a disability. Ideal CVH was defined as meeting the ideal levels of four behaviors (smoking, body mass index, physical activity, diet adherence) and three factors (total cholesterol, fasting glucose, blood pressure). Logistic regression analysis suggested that ideal physical activity reduces the odds of disability (odds ratio (OR) = 0.55, 95% confidence interval (CI) = 0.36–0.85). Moreover, participants with intermediate (3–4 metrics) (OR = 0.63, 95% CI = 0.41–0.97) and ideal (5–7 metrics) (OR = 0.51, 95% CI = 0.24–0.97) CVH profiles had lower odds of disability independent of history of vascular events and arthritis disease than those with a poor profile (0–2 metrics). In conclusion, despite the cross-sectional design, this study suggests the importance of promoting ideal CVH because of their relationship with disability.

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King Soopers and City Market Recalls Deli Broccoli Salads and Coleslaw Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

King Soopers said today it has recalled deli broccoli salads and coleslaw that are sold in King Soopers and City Market stores, located in Colorado, Utah, New Mexico and Wyoming. The product may be contaminated with Listeria monocytogenes.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies - FDA Press Releases

Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation.

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Community-Based Palliative Care and Advance Care Planning Documentation: Evidence from a Multispecialty Group - American Geriatric Society

Background/Objectives

With the growing public demand for access to critical health data across care settings, it is essential that advance care planning (ACP) information be included in the electronic health record (EHR) so that multiple clinicians can access it and understand individuals’ preferences for end-of-life care. Community-based palliative care programs often incorporate ACP services. This study examined whether a community-based palliative care program is associated with digitally extractable ACP documentation in the EHR.

Design

Observational study using propensity score–weighted generalized estimation equations to examine patterns of digitally extractable ACP documentation.

Setting

Palo Alto Medical Foundation (PAMF), a multispecialty ambulatory healthcare system in northern California.

Participants

Individuals aged 65 and older with serious illnesses between January 1, 2013, and December 31, 2014 (N = 3,444).

Intervention

Community-based palliative care program in PAMF.

Measurements

Digitally extractable ACP in EHR.

Results

We found that only 14% (n = 483) of individuals with serious illnesses had digitally extractable ACP in electronic health records. Of the 6% of individuals receiving palliative care, 65% had ACP, versus 11% of those not receiving palliative care. Study results showed a strong positive association between palliative care and ACP.

Conclusion

Only a small percentage of individuals with serious illnesses had ACP documentation in the EHR. Individuals with serious illnesses infrequently used palliative care delivered by board-certified palliative care specialists. Palliative care service use was associated with higher rates of ACP after controlling for organizational and individual characteristics using a propensity score weighting method. Scalable interventions targeted at non-palliative care clinicians for universal access to ACP are needed.

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Giant Eagle Voluntarily Recalls Breaded Shrimp Due to an Undeclared Egg Allergen - FDA Safety Alerts & Drug Recalls

All lot codes up to and including best by October 24, 2017 of Giant Eagle brand Breaded Shrimp, prepared and sold from the Prepared Foods grab and go sections inside Giant Eagle and Market District supermarkets through October 19, 2017 have been voluntarily recalled by Giant Eagle due to an undeclared egg allergen. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products. The product is safe for consumption by those who do not have egg allergies.

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FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues - FDA Press Releases

Today the U.S. Food and Drug Administration issued a warning letter to Magellan Diagnostics Inc. for several violations of federal law, including marketing significantly modified versions of two of its blood lead testing systems without the FDA’s required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results.

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Teaching Geriatric Concepts in Internal Medicine Residency Continuity Clinic Did Not Affect Practice - American Geriatric Society

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H-E-B Issues a Voluntary Precautionary Recall For Certain Single Serving Soups Sold In The Produce Section - FDA Safety Alerts & Drug Recalls

In accordance with Mann Packing of Salinas, California, H-E-B announced today that it has issued a voluntary recall for certain H-E-B single-serving soups made with vegetable products that may be contaminated with Listeria monocytogenes. As part of a larger recall affecting several retailers, Mann Packing recalled affected vegetable products on Oct. 19, which were supplied to H-E-B and used in H-E-B Asian Noodle Soup Cups Beef and Chicken.

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Triple B Corporation (Seattle, Washington) Recalls Salad Kits and Stir Fry Mixes Due to Possible Contamination with Listeria Monocytogenes - FDA Safety Alerts & Drug Recalls

Triple B Corporation of Seattle, Washington is voluntarily recalling salad kits and stir fry mixes due to possible contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

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Triple B Corporation (Anchorage, Alaska) Recalls Salad Kits and Stir Fry Mixes Due to Possible Contamination with Listeria Monocytogenes - FDA Safety Alerts & Drug Recalls

Triple B Corporation of Anchorage, Alaska is voluntarily recalling broccoli florette's, stir fry kit, vegie trays w/ cauliflower, and a veggie pack combo, due to possible contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

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Earthbound Farm LLC Issues Allergy Alert on Undeclared Milk and Egg in One Batch of Earthbound Farm Organic Chopped Asian Style Salad Kit - FDA Safety Alerts & Drug Recalls

Out of an abundance of caution, Earthbound Farm LLC of San Juan Bautista, CA is voluntarily recalling 1,755 cases of the Earthbound Farm Organic Chopped Asian Style Salad Kit with an expiration date of October 24, 2017 and UPC of 32601 95134, because it was discovered that some of the bags contain the dressing/toppings packets for the Southwest Chopped Salad Kit rather than for the Chopped Asian Style Kit. The Southwest dressing contains egg and milk that are not declared as ingredients on the bag of the Asian Style Salad Kit.

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Meijer Recalls Meijer Brand Packaged Produce Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Meijer is announcing a recall of various packaged Meijer brand produce items due to a potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms like high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, a Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.

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Randalls, Tom Thumb and Albertsons Stores in Texas, Louisiana and Arkansas Voluntarily Recall Ready. Chef. Go! Seafood Meal Bags in Cooperation with Voluntary Recall by Mann Packing Due to Possible Listeria Monocytogenes Contamination - FDA Safety Alerts & Drug Recalls

In cooperation with the Mann Packing recall of minimally processed vegetable products due to possible Listeria monocytogenes contamination, Randalls, Tom Thumb and Albertsons stores in Texas, Louisiana and Arkansas only are voluntarily recalling Ready. Chef. Go! seafood meal bags. The bags include vegetables that are subject to the Mann Packing recall.

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Albertsons, Safeway, Vons and Pak N' Save Stores in Eight States Voluntarily Recall Several Fresh Vegetable Trays and Cups in Cooperation with Voluntary Recall by Mann Packing Due to Possible Listeria Monocytogenes Contamination - FDA Safety Alerts & Drug Recalls

In cooperation with the Mann Packing recall of minimally processed vegetable products due to possible Listeria monocytogenes contamination, Albertsons, Safeway, Vons and Pak N' Save stores in eight states are voluntarily recalling certain fresh vegetable trays and cups that include vegetables that are subject to the Mann Packing recall.

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Mann Packing Recall Affects Select Whole Foods Market Locations; Grocer Recalls Salads from 10 Northern California Stores - FDA Safety Alerts & Drug Recalls

In response to Mann Packing's recall, Whole Foods Market is voluntarily recalling some salads from ten stores in Northern California out of an abundance of caution. Mann Packing issued the recall because the vegetables may be contaminated with listeria monocytogenes.

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Screening and Prevention in the Modern Era - Geriatrics

Prevention and early detection of treatable medical conditions is an appealing concept. Preventive health care encompasses primary prevention of illness (eg, immunization against infectious disease or adoption of a healthy lifestyle), secondary prevention that involves early detection of latent disease (eg, colon and breast cancer screening), or tertiary prevention that aims to limit disability or improve function for an individual with an existing condition (eg, exercise rehabilitation in chronic lung disease).

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Cardiovascular Screening and Primary Prevention in Older Adults - Geriatrics

Evidence for preventive screening and therapeutic intervention for primary prevention of cardiovascular disease is limited for older adults. In this article, we review screening and prevention strategies, including lifestyle, modifiable risk factors, and medications, that may be considered in older adults, with a focus on those ≥75 years, accounting for age, frailty and functional status, medical conditions, and life expectancy.

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BrightFarms Announces Voluntary Regional Recall of Produce Due to Potential Presence of E. coli - FDA Safety Alerts & Drug Recalls

BrightFarms is initiating a voluntary recall of packaged produce sold in Roundy's Supermarkets due to the potential presence of E. coli at its Rochelle, Illinois (Ogle County) greenhouse farm.

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SCA Pharmaceuticals Issues Voluntary Nationwide Recall of Specific Products Due to Potential Contamination - FDA Safety Alerts & Drug Recalls

SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling all/the following lots of the below listed injectable products to the hospital level. The is a potential for the products to contain microbial contamination. Administration of a drug product, intended to be sterile, that may contain microbial contamination has the potential to result in serious adverse events which may include life-threatening infections.

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Screening Older Adults for Mental Disorders - Geriatrics

Avoidable disability associated with depression, anxiety, and impaired cognition among older adults is pervasive. Incentives for detection of mental disorders in late life include increased reimbursement, reduced cost, and less burden for patients and families. However, screening not aligned with diagnosis, intervention, and outcome assessment has questionable utility. The link between screening, treatment, and outcomes is well established for depression, less so for anxiety and impaired cognition. This article details the use of common instruments to screen and assess depression, anxiety, and cognitive impairment.

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Medicare Open Enrollment – New Features make Shopping for 2018 Coverage Easier! - CMS Blog

By Seema Verma, Administrator, Centers for Medicare & Medicaid Services (CMS)

Each October, as the days grow shorter, time seems to speed up. Maybe it’s because we start planning for the looming holidays or begin bracing for the cold winter, but before we know it we’re saying goodbye to one year and ringing in a new one. That’s why it’s important to set aside some time between now and early December to think about your 2018 healthcare needs by shopping for high-quality Medicare health and drug plans during Open Enrollment.

Medicare Open Enrollment kicked off on October 15 and will run through December 7. I’m pleased to share that you will have better access to high-quality health coverage choices offering more options and lower premiums in 2018. This means you should be able to find plans that cost less but still give you quality care and better customer service. In fact, the number of Medicare Advantage plans available to individuals across the country is increasing from about 2,700 to more than 3,100 – and more than 85 percent of people with Medicare will have access to 10 or more Medicare Advantage plans. We are estimating that the average Medicare Advantage monthly premium will decrease by $1.91 in 2018, from an average of $31.91 in 2017 to $30. The Medicare prescription drug plan average basic premium is projected to decline for the first time since 2012 (a decrease of approximately $1.20 below the 2017 average basic premium of $34.70).

The choices available demonstrate the benefits of supply and demand market forces in a strong healthcare market. Consumers are demanding more from their insurance plans and in turn Medicare Advantage and Part D plans, like any business, are responding with better service at a lower cost leading to a truly patient-centered approach to healthcare.

Medicare is making some exciting changes of our own to make it easier for you to make an informed choice between Original Medicare and Medicare Advantage. You may have noticed a few of these changes in your Medicare & You handbook, but it doesn’t stop there. We’re improving our digital features on Medicare.gov, where you can sign-up to get timely notices about Open Enrollment and other important Medicare updates directly to your inbox. While on Medicare.gov be sure to check out the new help wizard that will point you to resources that will help you make informed healthcare decisions. These updates mirror the private sector and reflect a few ways we’re modernizing the customer service experience.

If you’ve been thinking about starting your new year with a Medicare Advantage or Prescription Drug Plan, or you’re interested in making some changes to your current plan, now is the time to shop for your coverage. Medicare health and drug plans change each year, and so can your health needs. That’s why it’s always a good idea to consider what needs you may have for 2018 and take a look at the available plans in your area.

Your coverage will begin on January 1, 2018. If you miss the deadline, you will likely have to wait a full year before you are able to make changes to your plan. During Open Enrollment, you can decide to stay in Original Medicare or join a Medicare Advantage Plan. If you find your current coverage still meets your healthcare needs, then you’re done.

Open Enrollment is also a good opportunity to make sure you’re doing everything you can to protect your identity and your health by guarding your Medicare card like you would a credit card. Identity theft resulting from stolen Medicare numbers is becoming more and more common. Medicare is here to help in the fight by removing Social Security Numbers from Medicare cards and replacing them with a new, unique number for each person with Medicare. Medicare will mail new Medicare cards with the new numbers between April 2018 and April 2019.

Don’t let the opportunity to have better quality healthcare at a lower price pass you by. Get a jump start on your new year’s health resolution today. You can visit Medicare.gov (http://www.medicare.gov), call 1-800-MEDICARE, or contact your State Health Insurance Assistance Program (SHIP) to learn more.

Filed under: Uncategorized

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Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico - FDA Press Releases

Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico

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Opiate Prescribing in Hospitalized Older Adults: Patterns and Outcomes - American Geriatric Society

Background/Objectives

Whereas opiate prescribing patterns have been well described in outpatient and emergency department settings, they have been less defined in hospitalized older adults. The objective was to describe patterns of opiate prescribing and associated outcomes in hospitalized older adults.

Design

Retrospective cohort study.

Setting

Tertiary care facility.

Participants

Hospitalized medical patients aged 65 and older (N = 9,245; mean age 80.3, 55.2% female, 72.3% white, 90.8% non-Hispanic).

Measurements

Opiate exposure and duration of action, concurrent use of potentially inappropriate medications (PIMs), adverse events, discharge disposition, length of stay (LOS), and 30-day readmissions.

Results

There was no difference in sex, race, ethnicity, or Charlson Comorbidity Index between opiate exposure groups. Participants who had never received opiates had a significantly shorter mean LOS than prior and new opiate users (5.2, 6.8, 7.7 days; P < .001) and were more likely to be discharged home (88.6%, 82.8%, 82.5%; P < .001) and significantly less likely to be readmitted within 30-days (19.6%, 25.0%, 22.3%; P < .001). Participant who had never been exposed to opiates had a significantly shorter mean LOS than those receiving short- and long-acting opiates (5.2, 7.3, 8.6 days; P < .001) and were more likely to be discharged home (88.6%, 82.6%, 82.4%; P < .001) and significantly less likely to be readmitted within 30-days (19.6%, 27.7%, 28.9%; P < .001).

Conclusion

Opiate use is widespread during hospitalization and is associated with significant negative clinical outcomes and quality metrics. There is an urgent need to develop innovative pain management alternatives to opiate use.

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Kiriko, LLC. Ban hành Quyết định Thu hồi Tự nguyện Toàn Quốc đối với sản phẩm A1 Slim Do có chứa các chất Sibutramine, Phenolphthalein và N-Desmethyl sibutramine Không được Khai báo - FDA Safety Alerts & Drug Recalls

Ngày 5 Tháng Mười, 2017-Manvel, TX, Kiriko, LLC. xin thu hồi tự nguyện tất cả các lô hàng A1 Slim dạng lọ chứa 30 viên con nhộng ở cấp độ người tiêu dùng. Phân tích trong phòng thí nghiệm của FDA đã phát hiện rằng sản phẩm A1 Slim có lẫn các chất sibutramine, phenolphthalein và N-Desmethyl sibutramine.

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FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma - FDA Press Releases

The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).

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Myanmar Wholesale Issues Allergy Alert On Undeclared Peanuts In Thanlwin Fried Bean Snack - FDA Safety Alerts & Drug Recalls

Myanmar Wholesale of Maplewood, Minnesota is recalling all packages of Thanlwin brand Fried Bean Snack, because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. Thanlwin Fried Bean Snack was distributed nationwide thru ethnic retail grocery stores.

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Weis Markets Issues Recall For Undeclared Egg Allergen In Store Made BLT Sandwiches - Sandwiches contain egg-based mayonnaise - FDA Safety Alerts & Drug Recalls

Weis Markets today said it has issued a recall for its store made bacon, lettuce and tomato (BLT) sandwiches since the product’s ingredient label does not list an egg allergen contained in the sandwich’s mayonnaise.

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Stonyfield Announces Nationwide Voluntary Recall of Specific Code Date of Strawberry O'Soy Soy Yogurt - FDA Safety Alerts & Drug Recalls

Organic yogurt maker, Stonyfield, is voluntarily recalling a specific code date of its O’Soy Strawberry soy yogurt because it may contain an undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

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Great Lakes Cheese Announces Recall Of American Accent Shredded Imitation Mozzarella Cheese Product - FDA Safety Alerts & Drug Recalls

Great Lakes Cheese Co. Inc. today announced the recall of 60 packages of American Accent Shredded Imitation Mozzarella Cheese with a best by date of JUN 8 2018 because of undeclared milk allergens on its label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

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Response to: ‘Lack of evidence for Zika virus transmission by Culex mosquitoes’

Response to: ‘Lack of evidence for Zika virus transmission by Culex mosquitoes’

Emerging Microbes & Infections 6, e91 (October 2017). doi:10.1038/emi.2017.86

Authors: Constância Ayres, Duschinka Guedes, Marcelo Paiva, Mariana Donato, Priscilla Barbosa, Larissa Krokovsky, Sura Rocha, Karina Saraiva, Mônica Crespo, Tatiana Rezende, Gabriel Wallau, Rosângela Barbosa, Cláudia Oliveira, Maria Alice Melo-Santos, Lindomar Pena, Marli Cordeiro, Rafael Franca, André Oliveira, Christina Peixoto & Walter S Leal

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Lack of evidence for Zika virus transmission by Culex mosquitoes

Lack of evidence for Zika virus transmission by Culex mosquitoes

Emerging Microbes & Infections 6, e90 (October 2017). doi:10.1038/emi.2017.85

Authors: Christopher M Roundy, Sasha R Azar, Aaron C Brault, Gregory D Ebel, Anna-Bella Failloux, Ildefonso Fernandez-Salas, Uriel Kitron, Laura D Kramer, Ricardo Lourenço-de-Oliveira, Jorge E Osorio, Igor D Paploski, Gonzalo M Vazquez-Prokopec, Guilherme S Ribeiro, Scott A Ritchie, Laura B Tauro, Nikos Vasilakis & Scott C Weaver

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Prehospital Delay in Older Adults with Acute Myocardial Infarction: The ComprehenSIVe Evaluation of Risk Factors in Older Patients with Acute Myocardial Infarction Study - American Geriatric Society

Background/Objectives

Timely administration of antiischemic therapies improves outcomes in individuals with acute myocardial infarction (AMI). Prior literature on delays in AMI care has largely focused on in-hospital delay (“door to balloon” time). Our objective was to identify factors associated with prehospital delay in a contemporary national cohort of older adults with AMI.

Design

Cross-sectional analysis of data from the ComprehenSIVe Evaluation of Risk Factors in Older Patients with Acute Myocardial Infarction (SILVER-AMI) study, an observational study of older adults hospitalized for AMI.

Setting

U.S. academic and community hospitals (N = 94).

Participants

Individuals aged 75 and older hospitalized for AMI (N = 2,500).

Measurements

Prehospital delay was defined as symptom duration of 6 hours or longer before hospital presentation and was obtained according to participant or caregiver report during AMI hospitalization. Potential predictors of delay from demographic, clinical presentation, comorbid conditions, function, and social support domains were obtained through in-person assessment during the index hospitalization and medical record abstraction.

Results

Nonwhite race (adjusted odds ratio (aOR) = 1.54, P = .002), atypical symptoms (aOR = 1.41, P = .001), and heart failure (HF) (aOR = 1.35, P = .006 for HF) were significantly associated with delay.

Conclusion

In contrast with younger AMI populations, female sex and diabetes mellitus were not associated with delay in this older cohort, but factors from other domains (nonwhite race, atypical symptoms, and HF) were significantly associated with delay. These results can be used to customize future public health efforts to encourage early presentation for older adults with AMI.

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Driving Dilemmas - Geriatrics

Clinical assessment of fitness to drive can be a challenging part of primary care of older adults. There are no guidelines on screening for driver safety, so it falls to provider judgment on when to assess older drivers. This review offers recommendations on when to assess for driver safety based on red flag conditions, medications, acute events, and patient or family concerns. It reviews how to assess for visual, cognitive, and neuromuscular impairments and what to do as next steps for at-risk drivers once they are identified. Laws regarding driver reporting are also reviewed.

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Preoperative Screening - Geriatrics

Older adults undergoing elective surgical procedures suffer higher rates of morbidity and mortality than younger patients. A geriatric-focused preoperative evaluation can identify risk factors for complications and opportunities for health optimization and care coordination. Key components of a geriatric preoperative evaluation include (1) assessments of function, mobility, cognition, and mental health; (2) reviews of medical conditions and medications; and (3) discussion of risks, preferences, and goals of care. A geriatric-focused, team-based approach can improve surgical outcomes and patient experience.

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Kenny’s Great Pies Issues Allergy Alert On Undeclared Wheat In "Kenny’s Buckeye Pie" - FDA Safety Alerts & Drug Recalls

Kenny’s Great Pies, Inc. of Smyrna, GA, is voluntarily recalling its 22 ounce packages of "Kenny’s Buckeye Pie" because they may contain undeclared wheat. People who have an allergy or severe sensitivity to wheat run the risk of serious or life-threatening allergic reaction if they consume these products.

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Secondary Prevention Medication Use After Myocardial Infarction in U.S. Nursing Home Residents - American Geriatric Society

Background/Objectives

Secondary prevention medications are recommended for older adults after acute myocardial infarction (AMI), but little is known about whether nursing home (NH) residents receive these medications. The objective was to evaluate new use of secondary prevention medications after AMI in NH residents who were previously nonusers and to evaluate what factors were associated with use.

Design

Retrospective cohort using linked national Minimum Data Set assessments; Online Survey, Certification and Reporting records; and Medicare claims.

Setting

U.S. NHs.

Participants

National cohort of 11,192 NH residents aged 65 and older who were hospitalized for an AMI between May 2007 and March 2010, had no beta-blocker or statin use for 4 months or longer before the hospitalization, and survived 14 days or more after NH readmission.

Measurements

The outcome was the number of secondary prevention medications initiated within 30 days of NH readmission.

Results

Thirty-seven percent of residents had no secondary prevention medications initiated after AMI, 41% had 1 initiated, and 22% had 2 initiated. After covariate adjustment, fewer secondary prevention medications were used in older residents (proportional odds ratio (POR) = 0.48, 95% confidence interval (CI)  = 0.40–0.57 for ≥95 vs 65–74); women (POR = 0.88, 95% CI = 0.80–0.96);and those with a do-not-resuscitate (DNR) order (POR = 0.90, 95% CI = 0.83–0.98), functional impairment (dependent or totally dependent vs independent to limited assistance, POR = 0.77, 95% CI = 0.69–0.86), and cognitive impairment (moderate to severe vs no impairment, POR = 0.79, 95% CI = 0.70–0.89).

Conclusion

More than one-third of older NH residents in the United States do not have any secondary prevention medications initiated after AMI, with fewer medications initiated in older residents; women; and those with, DNR orders, poor physical function, and cognitive impairment. A lack of evidence about the safety and effectiveness of secondary preventions medications in the NH population and unmeasured person-centered goals of care are plausible explanations for these findings.

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Association Between Neighborhood Cohesion and Self-Neglect in Chinese-American Older Adults - American Geriatric Society

Objectives

To examine the association between neighborhood cohesion and risk of self-neglect in a community-dwelling Chinese-American older population.

Setting

Community.

Participants

Chinese-American older adults aged 60 and older interviewed from 2011 to 2013 (N = 3,159).

Design

Data were drawn from the Population Study of Chinese Elderly, a cross-sectional community-engaged study in the greater Chicago area.

Measurements

Self-neglect was assessed with systematic observations of a participant's personal and home environment. Neighborhood cohesion was measured using six questions.

Results

After controlling for potential confounders, greater neighborhood cohesion was significantly associated with lower risk of overall self-neglect (odds ratio (OR) = 0.87, 95% confidence interval (CI) = 0.77–0.98) and moderate to severe self-neglect (OR = 0.70, 95% CI = 0.58–0.85) but not significantly associated with mild self-neglect (OR = 0.94, 95% CI = 0.82–1.09). Regarding the phenotypes of self-neglect, greater neighborhood cohesion was significantly associated with lower risk of poor personal hygiene (OR = 0.80, 95% CI = 0.67–0.96) and need for home repair (OR = 0.70, 95% CI = 0.60–0.83) but not significantly for hoarding (OR = 1.04, 95% CI = 0.89–1.21), unsanitary conditions (OR = 0.88, 95% CI = 0.76–1.02), and inadequate utilities (OR = 1.00, 95% CI = 0.77–1.31).

Conclusion

This study highlights the association between greater neighborhood cohesion and lower risk of overall self-neglect in Chinese-American older adults. Enhancing neighborhood cohesion may enhance elder self-neglect prevention and intervention.

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The Strategies to Reduce Injuries and Develop Confidence in Elders Intervention: Falls Risk Factor Assessment and Management, Patient Engagement, and Nurse Co-management - American Geriatric Society

In response to the epidemic of falls and serious falls-related injuries in older persons, in 2014, the Patient Centered Outcomes Research Institute (PCORI) and the National Institute on Aging funded a pragmatic trial, Strategies to Reduce Injuries and Develop confidence in Elders (STRIDE) to compare the effects of a multifactorial intervention with those of an enhanced usual care intervention. The STRIDE multifactorial intervention consists of five major components that registered nurses deliver in the role of falls care managers, co-managing fall risk in partnership with patients and their primary care providers (PCPs). The components include a standardized assessment of eight modifiable risk factors (medications; postural hypotension; feet and footwear; vision; vitamin D; osteoporosis; home safety; strength, gait, and balance impairment) and the use of protocols and algorithms to generate recommended management of risk factors; explanation of assessment results to the patient (and caregiver when appropriate) using basic motivational interviewing techniques to elicit patient priorities, preferences, and readiness to participate in treatments; co-creation of individualized falls care plans that patients’ PCPs review, modify, and approve; implementation of the falls care plan; and ongoing monitoring of response, regularly scheduled re-assessments of fall risk, and revisions of the falls care plan. Custom-designed falls care management software facilitates risk factor assessment, the identification of recommended interventions, clinic note generation, and longitudinal care management. The trial testing the effectiveness of the STRIDE intervention is in progress, with results expected in late 2019.

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Spicely Organics Recalls Organic Tarragon Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Organic Spices, Inc. dba Spicely Organics of Fremont, CA is recalling 0.4 oz. Organic Tarragon Lot No. OTW100134 because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Aunt Beth’s Cookies Allergy Alert On Undeclared Nuts In Cookies - FDA Safety Alerts & Drug Recalls

Aunt Beth’s Cookies in Mishawaka, IN is voluntarily recalling certain baked cookies sold between January 1, 2017 and September 28, 2017 because they may contain traces of undeclared peanut or tree-nut allergens. People who have an allergy or severe sensitivity to peanuts and tree nuts run the risk of serious or life-threatening allergic reaction if they consume this product.

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Can Physical Activity Prevent Falls in Older Adults with Poor Physical Performance? - American Geriatric Society

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The Geometry of Patient Safety: Horizontal and Vertical Approaches to the Hazards of Hospitalization - American Geriatric Society

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Allergy Alert Issued In 13 Whole Foods Market Stores for Undeclared Egg in Apple Cinnamon Hand Pies - FDA Safety Alerts & Drug Recalls

Select Whole Foods Market stores in Arizona, California and Nevada are voluntarily recalling apple cinnamon hand pies because the products contained egg that was not listed on the product label. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

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Screening for Medication Appropriateness in Older Adults - Geriatrics

Older adults are at high risk for inappropriate medication use given their myriad medical conditions and medications. Screening efforts may seem overwhelming, but starting with a focused approach and leveraging a team-based strategy can help practicing clinicians gain initial momentum. Future research is needed to strengthen the evidence base for medication use in older adults and to elucidate effective and scalable interventions to improve medication safety.

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Individualized Approach to Cancer Screening in Older Adults - Geriatrics

The primary goal of cancer screening is early detection of cancer to reduce cancer-specific mortality and morbidity. The benefits of screening in older adults are uncertain due to paucity of evidence. Extrapolating data from younger populations, evidence suggests that the benefit occurs years later from the time of initial screening and therefore may not be applicable in those older adults with limited life expectancy. Contrast this with the harms of screening, which are more immediate and increase with age and comorbidities. An individualized approach to cancer screening takes these factors into consideration, allowing for thoughtful decision making for older adults.

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Vaccinations in Older Adults - Geriatrics

Vaccines are important for preventing infections in adults aged ≥65 years. Older adults are at increased risk for complications from vaccine-preventable illnesses due to age-associated changes in immune function and chronic medical comorbidities. Vaccination rates for older adults remain low despite widely accepted practice guidelines. Recommended vaccinations for older adults include (1) influenza; (2) pneumococcal; (3) herpes zoster; (4) tetanus, diphtheria, pertussis; and (5) hepatitis B. Cost influences vaccination rates in older adults.

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Screening for Geriatric Syndromes - Geriatrics

The geriatric syndromes of falls, incontinence, and osteoporosis are concerns in older adults because of their potential impact on quality of life. Asking about history of falls or a fear of falling should prompt a multifactorial assessment of fall risk and targeted interventions to reduce falls. Urinary and fecal incontinence should be screened because they are common conditions that are underreported due to embarrassment and general perception that incontinence is a normal part of aging. Women over age 65, men over age 70, and younger patients with high-risk characteristics should be screened with bone mineral density testing with dual-energy x-ray absorptiometry.

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A.S.K. Foods, Inc. Issues Allergy Alert On Undeclared Egg In Taste Of Inspirations Classic Red Skin Potato Salad Net. Weight 16 Oz. (454g) - FDA Safety Alerts & Drug Recalls

A.S.K. Foods, Inc. of Palmyra, Pennsylvania is voluntarily recalling one lot of Hannaford Supermarkets’ TASTE OF INSPIRATIONS CLASSIC RED SKIN POTATO SALAD Net Wt. 16 oz. (454g) because it may contain undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

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FDA clears new robotically-assisted surgical device for adult patients - FDA Press Releases

Today, the U.S. Food and Drug Administration cleared the Senhance System, a new robotically-assisted surgical device (RASD) that can help facilitate minimally invasive surgery.

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California dietary supplement maker, Custompax prohibited from manufacturing - FDA Press Releases

A California dietary supplement manufacturer recently was ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and other requirements listed in a consent decree.

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Bel Brands USA, Inc. Issues a Nationwide Voluntary Recall Of Merkts Port Wine Cheese Spread Because Of Possible Foreign Bodies Found In a Limited Batch Of Products - FDA Safety Alerts & Drug Recalls

Bel Brands USA, Inc. is issuing a voluntary recall of Merkts Port Wine Cheese Spread sold nationwide with a 9-1-17 production date and a “BEST BEFORE” date of 04-29-18 because a few consumers have reported finding small pieces of plastic in the product.

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Statement by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery in Puerto Rico - FDA Press Releases

Statement by FDA Commissioner Scott Gottlieb, M.D. on Baxter manufacturing recovery in Puerto Rico

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UPDATE: Greencore USA, LLC Recalls Egg Salad Sandwiches, Ham Salad Sandwiches, and Seafood Stuffing Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Greencore, USA, LLC is voluntarily recalling egg salad sandwiches, ham salad sandwiches, and seafood stuffing as listed below. The products are being recalled because Listeria monocytogenes was found in environmental sampling conducted by FDA.

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Readily Identifiable Risk Factors of Nursing Home Residents’ Oral Hygiene: Dementia, Hospice, and Length of Stay - American Geriatric Society

Background/Objectives

The poor oral hygiene of nursing home (NH) residents is a matter of increasing concern, especially because of its relationship with pneumonia and other health events. Because details and related risk factors in this area are scant and providers need to be able to easily identify those residents at most risk, this study comprehensively examined the plaque, gingival, and denture status of NH residents, as well as readily available correlates of those indicators of oral hygiene, including items from the Minimum Data Set (MDS).

Design

Oral hygiene assessment and chart abstract conducted on a cross-section of NH residents.

Setting

NHs in North Carolina (N = 14).

Participants

NH residents (N = 506).

Measurements

Descriptive data from the MDS and assessments using three standardized measures: the Plaque Index for Long-Term Care (PI-LTC), the Gingival Index for Long-Term Care (GI-LTC), and the Denture Plaque Index (DPI).

Results

Oral hygiene scores averaged 1.7 (of 3) for the PI-LTC, 1.5 (of 4) for the GI-LTC, and 2.2 (of 4) for the DPI. Factors most strongly associated with poor oral hygiene scores included having dementia, being on hospice care, and longer stay. MDS ratings of gingivitis differed significantly from oral hygiene assessments.

Conclusions

The findings identify resident subgroups at especially high risk of poor oral health who can be targeted in quality improvement efforts related to oral hygiene; they also indicate need to improve the accuracy of how MDS items are completed.

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FDA clears first 7T magnetic resonance imaging device - FDA Press Releases

Today, the U.S. Food and Drug Administration cleared the first seven tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the United States. The Magentom Terra is the first 7T MRI system cleared for clinical use in the United States.

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La Terra Fina Recalls 10 oz. Spinach Artichoke & Parmesan Dip & Spread Due to Mislabeling and Undeclared Allergen - FDA Safety Alerts & Drug Recalls

La Terra Fina is voluntarily recalling its 10 oz. containers of Spinach Artichoke & Parmesan Dip & Spread with the date of BEST BY NOV-01-2017 due to undeclared egg. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product.

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Statement by FDA Commissioner Scott Gottlieb, M.D. on new steps by FDA to advance patient engagement in the agency’s regulatory work - FDA Press Releases

The Food and Drug Administration is hosting a pioneering event today: the first meeting of the Patient Engagement Advisory Committee or PEAC. It’s a significant step forward in the FDA’s efforts to broaden its engagement with patients – and to deepen the involvement of patients in our regulatory activities.

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Neutralization of Zika virus by germline-like human monoclonal antibodies targeting cryptic epitopes on envelope domain III

Neutralization of Zika virus by germline-like human monoclonal antibodies targeting cryptic epitopes on envelope domain III

Emerging Microbes & Infections 6, e89 (October 2017). doi:10.1038/emi.2017.79

Authors: Yanling Wu, Shun Li, Lanying Du, Chunyu Wang, Peng Zou, Binbin Hong, Mengjiao Yuan, Xiaonan Ren, Wanbo Tai, Yu Kong, Chen Zhou, Lu Lu, Xiaohui Zhou, Shibo Jiang & Tianlei Ying

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Genetic variation of Sporothrix globosa isolates from diverse geographic and clinical origins in China

Genetic variation of Sporothrix globosa isolates from diverse geographic and clinical origins in China

Emerging Microbes & Infections 6, e88 (October 2017). doi:10.1038/emi.2017.75

Authors: Lipei Zhao, Yan Cui, Yu Zhen, Lei Yao, Ying Shi, Yang Song, Ruili Chen & Shanshan Li

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Epidemiology and antifungal susceptibility of candidemia isolates of non-albicans Candida species from cancer patients

Epidemiology and antifungal susceptibility of candidemia isolates of non-albicans Candida species from cancer patients

Emerging Microbes & Infections 6, e87 (October 2017). doi:10.1038/emi.2017.74

Authors: Ping-Feng Wu, Wei-Lun Liu, Min-Han Hsieh, Ing-Moi Hii, Yu-Lin Lee, Yi-Tsung Lin, Mao-Wang Ho, Chun-Eng Liu, Yen-Hsu Chen & Fu-Der Wang

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Molecular analysis of pyrazinamide resistance in Mycobacterium tuberculosis in Vietnam highlights the high rate of pyrazinamide resistance-associated mutations in clinical isolates

Molecular analysis of pyrazinamide resistance in Mycobacterium tuberculosis in Vietnam highlights the high rate of pyrazinamide resistance-associated mutations in clinical isolates

Emerging Microbes & Infections 6, e86 (October 2017). doi:10.1038/emi.2017.73

Authors: Nguyen Quang Huy, Contamin Lucie, Tran Thi Thanh Hoa, Nguyen Van Hung, Nguyen Thi Ngoc Lan, Nguyen Thai Son, Nguyen Viet Nhung, Dang Duc Anh, Bañuls Anne-Laure & Nguyen Thi Van Anh

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Usutu virus, Austria and Hungary, 2010–2016

Usutu virus, Austria and Hungary, 2010–2016

Emerging Microbes & Infections 6, e85 (October 2017). doi:10.1038/emi.2017.72

Authors: Tamás Bakonyi, Károly Erdélyi, René Brunthaler, Ádám Dán, Herbert Weissenböck & Norbert Nowotny

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The Medicare Annual Wellness Visit - Geriatrics

The Medicare Annual Wellness Visit is an annual preventive health benefit, which was created in 2011 as part of the Patient Protection and Affordable Care Act. The visit provides an opportunity for clinicians to review preventive health recommendations and screen for geriatric syndromes. In this article, the authors review the requirements of the Annual Wellness Visit, discuss ways to use the Annual Wellness Visit to improve the care of geriatric patients, and provide suggestions for how to incorporate this benefit into a busy clinic.

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Exercise and Older Adults - Geriatrics

Regular exercise is essential for healthy aging and offers many health benefits, including reduced risk of all-cause mortality, chronic disease, and premature death. Because physical inactivity is prevalent, greater focus is needed on integrating exercise into care plans and counseling, and developing partnerships that support exercise opportunities. Older adults should be as physically active as their abilities and conditions allow. For substantial health benefits, older adults need to do aerobic, muscle-strengthening, and stretching exercises weekly, and balance activities as needed. Appropriate planning must take account of factors such as prescribed medications, nutrition, injuries, hip and knee arthroplasties, and chronic conditions.

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General Mills Issues Voluntary Recall of Cascadian Farm Organic Cinnamon Raisin Granola Cereal - FDA Safety Alerts & Drug Recalls

General Mills is voluntarily recalling two days of production of Cascadian Farm Organic Cinnamon Raisin Granola cereal because of an undeclared allergen. There have been no reports of illness.

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Great American Deli Issues Allergy Alert On Undeclared Egg And Soy In Premium Chicken Salad Wheatberry Sandwich - FDA Safety Alerts & Drug Recalls

Great American Deli of Ooltewah, Tennessee is recalling 816 Premium Chicken Salad Wheatberry Sandwich Lot Number 17 198 because they have the wrong ingredient statement and contain undeclared eggs and soy. People who have an allergy or severe sensitivity to eggs or soy run the risk of serious or life-threatening allergic reaction if they consume these products.

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Predicting Discharge to Institutional Long-Term Care After Stroke: A Systematic Review and Metaanalysis - American Geriatric Society

Background/Objectives

Stroke is a leading cause of disability worldwide, and a significant proportion of stroke survivors require long-term institutional care. Understanding who cannot be discharged home is important for health and social care planning. Our aim was to establish predictive factors for discharge to institutional care after hospitalization for stroke.

Design

We registered and conducted a systematic review and meta-analysis (PROSPERO: CRD42015023497) of observational studies. We searched MEDLINE, EMBASE, and CINAHL Plus to February 2017. Quantitative synthesis was performed where data allowed.

Setting

Acute and rehabilitation hospitals.

Participants

Adults hospitalized for stroke who were newly admitted directly to long-term institutional care at the time of hospital discharge.

Measurements

Factors associated with new institutionalization.

Results

From 10,420 records, we included 18 studies (n = 32,139 participants). The studies were heterogeneous and conducted in Europe, North America, and East Asia. Eight studies were at high risk of selection bias. The proportion of those surviving to discharge who were newly discharged to long-term care varied from 7% to 39% (median 17%, interquartile range 12%), and the model of care received in the long-term care setting was not defined. Older age and greater stroke severity had a consistently positive association with the need for long-term care admission. Individuals who had a severe stroke were 26 times as likely to be admitted to long-term care than those who had a minor stroke. Individuals aged 65 and older had a risk of stroke that was three times as great as that of younger individuals. Potentially modifiable factors were rarely examined.

Conclusion

Age and stroke severity are important predictors of institutional long-term care admission directly from the hospital after an acute stroke. Potentially modifiable factors should be the target of future research. Stroke outcome studies should report discharge destination, defining the model of care provided in the long-term care setting.

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Prevention and Screening of Unhealthy Substance Use by Older Adults - Geriatrics

The number of older adults who engage in unhealthy substance use is expected to increase substantially to levels never seen before. Older adults, owing to physiologic changes in aging, are at high risk for the adverse effects of alcohol and illegal drug use. Screening and prevention can help older patients to be better informed of the risks of substance use, and reduce high-risk behaviors and its potential negative outcomes. The authors review the prevalence and trends of substance use and their potential impact on health outcomes, and discuss an approach to screening and prevention for older adults.

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Pulmonary Disease in the Aging Patient - Geriatrics

Every 24 hours, 10,000 liters of air are breathed into the lungs. This means that on a daily basis, we are exposed to large amounts of suspended particulate matter, noxious gasses, aeroallergens, and microbes that have the potential to cause disease. Changes in the immune system of elderly individuals (>65 years) coupled with aging-related physiologic changes of the respiratory system make this population more vulnerable to these dangers from the environment. While the protective mechanisms of the lungs are highly effective on most days, on very high pollution days, there are more hospital admissions in the elderly population for conditions such as pneumonia, chronic obstructive pulmonary disease (COPD) and asthma exacerbations, and coronary artery disease.

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Forthcoming Issue - Geriatrics

Screening and Prevention in Geriatric Medicine

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Contents - Geriatrics

Sidney S. Braman and Gwen S. Skloot

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Contributors - Geriatrics

SIDNEY S. BRAMAN, MD, FCCP

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Copyright - Geriatrics

ELSEVIER

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Pulmonary Disease in the Aging Patient - Geriatrics

CLINICS IN GERIATRIC MEDICINE

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Whole Foods Market Issues Nationwide Allergy Alert on Undeclared Peanuts in 365 Everyday Value Organic Raisin Bran - FDA Safety Alerts & Drug Recalls

Whole Foods Market stores is voluntarily recalling 365 Everyday Value Organic Raisin Bran because the product contains undeclared peanuts that were not listed on the product label. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.

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FDA approves implantable device to treat moderate to severe central sleep apnea - FDA Press Releases

The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. The Remedē System is an implantable device that stimulates a nerve located in the chest that is responsible for sending signals to the diaphragm to stimulate breathing.

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Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s continued assistance following the natural disaster in Puerto Rico - FDA Press Releases

FDA continues extensive efforts to provide direct assistance to the residents of Puerto Rico following Hurricanes Irma and Maria, and is taking new steps to mitigate the impact of these twin disasters on the island’s vibrant medical product manufacturing sector. Our top priority is the people of Puerto Rico.

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Kiriko, LLC. Issues Voluntary Nationwide Recall of A1 Slim Due to Undeclared Sibutramine, Phenolphthalein and N-Desmethyl sibutramine - FDA Safety Alerts & Drug Recalls

, Kiriko, LLC. is voluntarily recalling all lots of A1 Slim 30 capsules bottle to the consumer level. FDA laboratory analysis has found the A1 Slim product to be tainted with sibutramine, phenolphthalein and N-Desmethyl sibutramine.

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FDA awards six grants for natural history studies in rare diseases - FDA Press Releases

The U.S. Food and Drug Administration today announced it has awarded six new research grants for natural history studies in rare diseases. The aim of the research is to inform medical product development by better understanding how specific rare diseases progress over time. One potential application of these studies is the opportunity to eventually use natural history models to augment the need for placebo arms in studies of drugs that target very rare disease, where trial recruitment can be challenging.

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FDA awards 15 grants for clinical trials to stimulate product development for rare diseases - FDA Press Releases

The U.S. Food and Drug Administration today announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and industry across the country.

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FDA approves first test for screening Zika virus in blood donations - FDA Press Releases

The U.S. Food and Drug Administration today approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors.

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Baxter Initiates Voluntary Nationwide Recall of One Shipment of Intralipid 20% IV Fat Emulsion Due to Product Being Exposed to Subfreezing Temperatures - FDA Safety Alerts & Drug Recalls

Baxter International Inc. announced today it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the United States, to the user level. The product has been exposed to subfreezing temperatures during transit to a distribution facility. The subfreezing temperature is outside of the acceptable storage range listed on the product labeling. Other shipments of this lot are not affected by this issue.

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Gadget Island, Inc. dba Gear Isle Issues Voluntary Nationwide Recall of Rhino 7 Platinum 5000, Papa Zen 3300, Fifty Shades 6000 and Grande X 5800, Due to Presence of Undeclared Sildenafil, Tadalafil and Desmethyl Carbodenafil - FDA Safety Alerts & Drug Recalls

Newark, CA, Gadget Island, Inc. is voluntarily recalling Rhino 7 Platinum 5000 capsules, All LOTS, Papa Zen 3300 capsules, LOT# NSS050888, Fifty Shades 6000 capsules, all Lots, Grande X 5800 capsules, all Lots, to the consumer level. FDA analysis has found the products to be tainted with Sildenafil and Tadalafil, which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED), as well as Desmethyl Carbodenafil which is structurally similar to sildenafil. The presence of Sildenafil, Tadalafil and or Desmethyl Carbodenafil in Rhino 7 Platinum 5000, Papa Zen 3300, Fifty Shades 6000, and Grande X 5800, renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.

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Inappropriate Prescribing in Older Hospitalized Adults: A Comparison of Medical Specialties - American Geriatric Society

Objectives

To evaluate the prevalence and number of potentially inappropriate medications (PIMs) in hospitalized older adults, comparing prescription patterns of medical specialties.

Design

Retrospective cohort study.

Setting

Tertiary general hospital.

Participants

All older adults hospitalized from January through May 2015 (N = 1,900).

Measurements

Information on medications prescribed during the first and last days of hospitalization was collected and evaluated regarding PIMs using Beers and Screening Tool of Older People's Prescriptions (STOPP) criteria. Medical specialties (internal medicine, cardiology, gastroenterology, infectious disease, nephrology, neurology, pneumology) were compared regarding the prevalence of PIMs and the increase in the number of PIMs during hospitalization.

Results

The number of individuals with PIMs increased significantly according to both criteria (62.3% to 66.6% according to Beers criteria, 43.4% to 50.0% according to STOPP criteria). The most common PIMs were sliding-scale insulin (26.9%), clonazepam (9.5%), and periciazine (6.4%) using Beers criteria and spironolactone (10.3%), acetylsalicylic acid (9.8%), and periciazine (8.7%) using STOPP criteria. Neurology, infectious disease, and pneumology had the highest numbers of PIMs, and neurology, pneumology, and cardiology had a greater increase in PIMs during hospitalization than the other specialties.

Conclusion

This study demonstrates the high and growing prevalence of PIMs in the hospital environment, according to Beers and STOPP criteria. Educational measures and specific pharmaceutical interventions for each specialty are needed to change this situation.

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Sid Wainer & Son® Initiates Class 1 Recall for Jansal Valley® Dried Chili De Arbol Peppers Due to Possible Health Risk - FDA Safety Alerts & Drug Recalls

Sid Wainer & Son® of New Bedford, MA is voluntarily recalling Jansal Valley® brand Dried Chili De Arbol Peppers because it does not have the proper allergens identified, being peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.

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Tai Foong Usa Issues Allergy Alert on Undeclared Egg in Product - FDA Safety Alerts & Drug Recalls

TAI FOONG USA of Seattle, WA is recalling Royal Asia Shrimp Wonton Noodle Soup, because it may contain undeclared EGG. People who have an allergy or severe sensitivity to Egg or egg products run the risk of serious or life-threatening allergic reaction if they consume these products. Individuals who are not allergic to eggs may safely consume this product.

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Dean Dairy Conducts Voluntary Recall of Tampico® Brand Tropical Punch in Illinois, Indiana and Wisconsin Because It May Contain Undeclared Allergen (Milk) - FDA Safety Alerts & Drug Recalls

Impacts only the gallon-size Tropical Punch flavor of Tampico® bottled and distributed by Dean Dairy and sold in Illinois, Indiana and Wisconsin. All affected product has the “Best By” date of 12-27-17.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse Event Reporting System (FAERS) and new search tool - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse Event Reporting System (FAERS) and new search tool

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