Hong Lee Trading Inc. Issues Allergen Alert On Undeclared Milk Allergens In Vina Café Wake-Up Instant Coffee - FDA Safety Alerts & Drug Recalls

Hong Lee Trading Inc., NY, is recalling its VINA CAFÉ WAKE-UP INSTANT COFFEE MIX in 18 PACK CARDBOARD BOXES (.6 oz packs), with lot “EXP:17.MAR.2019 1T13.” because they contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product.

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Greencore USA, LLC Recalls Chicken Salad and Ham 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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Chun Yuen Trading Co. Issues Allergy Alert On Undeclared Milk - FDA Safety Alerts & Drug Recalls

Chun Yuen Trading Co. of South El Monte, California, is recalling its 12.7 oz of 4-in-1 Reishi Coffee due to a mislabeling of the outer packaging, which contains undeclared milk content. People who are allergic to milk run the risk of serious or life threatening allergic reaction if they consume these products.

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Global Sensory Impairment Predicts Morbidity and Mortality in Older U.S. Adults - American Geriatric Society

Objectives

To evaluate global sensory impairment (GSI, an integrated measure of sensory dysfunction) as a predictor of physical function, cognition, overall health, and mortality.

Design

Prospective study.

Setting

The National Social Life, Health, and Aging Project.

Participants

A national probability sample of 3,005 home-dwelling older U.S. adults assessed at baseline (2005–06) and 5-year follow-up (2010–11).

Measurements

Gait speed, activity, disability, cognition, overall health, 5-year mortality.

Results

At baseline, older adults with worse GSI were slower (Timed Up and Go times: odds ratio (OR) = 1.32, 95% confidence interval (CI) = 1.17–1.50) and had more activity of daily living deficits (≥2: OR = 1.26, 95% CI = 1.10–1.46). Five years later, they were still slower (timed walk: OR = 1.22, 95% CI = 1.05–1.42), had more disabilities (≥2 instrumental activities of daily living; OR = 1.45, 95% CI = 1.23–1.70), were less active (daytime activity according to accelerometry: β = −2.7, 95% CI = −5.2 to −0.2), had worse cognitive function (Montreal Cognitive Assessment; β = −0.64, 95% CI = −0.84 to −0.44), more likely to have poorer overall health (OR = 1.16, 95% CI = 1.03–1.31) and lose weight (>10%: OR = 1.31, 95% CI = 1.04–1.64), and have died (OR = 1.45, 95% CI = 1.19–1.76). All analyses were adjusted for relevant confounders at baseline, including age, sex, race and ethnicity, education, smoking, problem drinking, body mass index, comorbidities, and cognitive function.

Conclusion

GSI predicts impaired physical function, cognitive dysfunction, significant weight loss, and mortality 5 years later in older U.S. adults. Multisensory evaluation may identify vulnerable individuals, offering the opportunity for early intervention to mitigate adverse outcomes.

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FDA improves access to reports of adverse drug reactions - FDA Press Releases

The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.

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FDA approves new treatment for certain advanced or metastatic breast cancers - FDA Press Releases

The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy).

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FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration - FDA Press Releases

The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”).

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King Soopers Recalls Deli Chicken Salad Sandwich (6.8oz) Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

King Soopers said today it has recalled its chicken salad sandwiches 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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Individualized Acute Medical Care for Cognitively Impaired Individuals: A Call Always to Pause Before Hospitalization - American Geriatric Society

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Elder-Friendly Emergency Department: Development and Validation of a Quality Assessment Tool - American Geriatric Society

Objectives

To develop and validate a comprehensive quality assessment tool for emergency department (ED) geriatric care.

Design

Four-step study: (1) Content development of tool by a multidisciplinary panel, (2) survey of ED lead physicians and nurses, (3) development of subscales using principal component analysis and clinical judgment, (4) reliability and validity assessment.

Setting

Province of Quebec, Canada.

Participants

Lead ED nurses and physicians at 76 Quebec EDs who participated in a 2013/14 survey (66% of 116 adult nonpsychiatric EDs in the province).

Measurements

Geriatric care items (n = 62) grouped into seven preliminary content areas (screening and assessment, clinical protocols, discharge planning, staffing, physical environment, continuing education, quality assessment), lead nurse and physician perceptions of the quality of ED geriatric care, institutional prioritization of geriatric care, and ED type.

Results

Thirteen subscales were developed; most were associated with ED type and quality indicators.

Conclusion

Thirteen subscales for geriatric ED services are proposed for evaluation in various ED settings.

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Understanding Quality of Care in Medicare Home Health Agency Care - American Geriatric Society

This editorial comments on the article by Krumholz et al.

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Home Health Agency Performance in the United States: 2011–15 - American Geriatric Society

Objectives

To evaluate home health agency quality performance.

Design

Observational study.

Setting

Home health agencies.

Participants

All Medicare-certified agencies with at least 6 months of data from 2011 to 2015.

Measurements

Twenty-two quality indicators, five patient survey indicators, and their composite scores.

Results

The study included 11,462 Medicare-certified home health agencies that served 92.4% of all ZIP codes nationwide, accounting for 315.2 million people. The mean composite scores were 409.1 ± 22.7 out of 500 with the patient survey indicators and 492.3 ± 21.7 out of 600 without the patient survey indicators. Home health agency performance on 27 quality indicators varied, with the coefficients of dispersion ranging from 4.9 to 62.8. Categorization of agencies into performance quartiles revealed that 3,179 (27.7%) were in the low-performing group (below 25th percentile) at least one time during the period from 2011–12 to 2014–15 and that 493 were in the low-performing group throughout the study period. Geographic variation in agency performance was observed. Agencies with longer Medicare-certified years were more likely to have high-performing scores; agencies providing partial services, with proprietary ownership, and those with long travel distances to reach patients had lower performance. Agencies serving low-income counties and counties with lower proportions of women and senior residences and greater proportions of Hispanic residents were more likely to attain lower performance scores.

Conclusion

Home health agency performance on several quality indicators varied, and many agencies were persistently in the lowest quartile of performance. Still, there is a need to improve the quality of care of all agencies. Many parts of the United States, particularly lower-income areas and areas with more Hispanic residents, are more likely to receive lower quality home health care.

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National Structural Survey of Veterans Affairs Home-Based Primary Care Programs - American Geriatric Society

Objectives

To describe the current structural and practice characteristics of the Department of Veterans Affairs (VA) Home-Based Primary Care (HBPC) program.

Design

We designed a national survey and surveyed HBPC program directors on-line using REDCap.

Participants

We received 236 surveys from 394 identified HBPC sites (60% response rate).

Measurements

HBPC site characteristics were quantified using closed-ended formats.

Results

HBPC program directors were most often registered nurses, and HBPC programs primarily served veterans with complex chronic illnesses that were at high risk of hospitalization and nursing home care. Primary care was delivered using interdisciplinary teams, with nurses, social workers, and registered dietitians as team members in more than 90% of the sites. Most often, nurse practitioners were the principal primary care providers (PCPs), typically working with nurse case managers. Nearly 60% of the sites reported dual PCPs involving VA and community-based physicians. Nearly all sites provided access to a core set of comprehensive services and programs (e.g., case management, supportive home health care). At the same time, there were variations according to site (e.g., size, location (urban, rural), use of non-VA hospitals, primary care models used).

Conclusion

HBPC sites reflected the rationale and mission of HBPC by focusing on complex chronic illness of home-based veterans and providing comprehensive primary care using interdisciplinary teams. Our next series of studies will examine how HBPC site structural characteristics and care models are related to the processes and outcomes of care to determine whether there are best practice standards that define an optimal HBPC structure and care model or whether multiple approaches to HBPC better serve the needs of ceterans.

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Risk of Fracture in Women with Sarcopenia, Low Bone Mass, or Both - American Geriatric Society

Objectives

To determine whether women with sarcopenia and low bone mineral density (BMD) are at greater risk of clinical fractures than those with sarcopenia or low BMD alone.

Design

Women's Health Initiative (WHI) Observational and Clinical trials.

Setting

Three U.S. clinical centers (Pittsburgh, PA; Birmingham, AL; Phoenix/Tucson, AZ).

Participants

Women (mean age 63.3 ± 0.07) with BMD measurements (N = 10,937).

Measurements

Sarcopenia was defined as appendicular lean mass values corrected for height and fat mass. Low BMD was defined as a femoral neck T-score less than −1.0 based on the Third National Health and Nutrition Examination Survey reference database for white women. Cox proportional hazards analysis was used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). We followed women for incident fractures over a median of 15.9 years.

Results

Participants were classified into mutually exclusive groups based on BMD and sarcopenia status: normal BMD and no sarcopenia (n = 3,857, 35%), sarcopenia alone (n = 774, 7%), low BMD alone (n = 4,907, 45%), and low BMD and sarcopenia (n = 1,399, 13%). Women with low BMD, with (HR = 1.72, 95% CI = 1.44–2.06) or without sarcopenia (HR = 1.58, 95% CI = 1.37–1.83), had greater risk of fracture than women with normal BMD; the difference remained statistically significant after adjustment for important covariates. Women with low BMD, with (HR = 2.78, 95% CI = 1.78–4.30 and without (HR = 2.42, 95% CI = 1.63–3.59) sarcopenia had higher risk of hip fractures. Women with sarcopenia alone had similar HRs to women with normal BMD.

Conclusion

Compared to women with normal BMD.

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F-36316 A and B, novel vasoactive compounds, isolated from Incrucipulum sp. SANK 10414 - Journal of Antibiotics

F-36316 A and B, novel vasoactive compounds, isolated from Incrucipulum sp. SANK 10414

The Journal of Antibiotics 70, 981 (October 2017). doi:10.1038/ja.2017.84

Authors: Yuki Hirota-Takahata, Yoko Ishimoto, Emi Kurosawa, Yuko Iwadate, Yoshiko Onozawa, Isshin Tanaka, Masahiro Tanaka & Hideki Kobayashi

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Novel p-terphenyl glycoside with a rare 2,6-dideoxyhexopyranose moiety from Actinomycete strain SF2911 that inhibits cancer cell migration - Journal of Antibiotics

Novel p-terphenyl glycoside with a rare 2,6-dideoxyhexopyranose moiety from Actinomycete strain SF2911 that inhibits cancer cell migration

The Journal of Antibiotics 70, 987 (October 2017). doi:10.1038/ja.2017.83

Authors: Liyan Wang, Menjie Li, Jianqiang Tang, Yinzhi Lin, Kulrawee Sidthipong, Naomi Sumida, Nobuaki Kushida & Kazuo Umezawa

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New anti-inflammatory metabolites produced by Streptomyces violaceoruber isolated from Equus burchelli feces - Journal of Antibiotics

New anti-inflammatory metabolites produced by Streptomyces violaceoruber isolated from Equus burchelli feces

The Journal of Antibiotics 70, 991 (October 2017). doi:10.1038/ja.2017.75

Authors: Jian Ma, Hui Lei, Xiu Chen, Xiaoxu Bi, Yi Jiang, Li Han & Xueshi Huang

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Virgisporangium myanmarense sp. nov., a novel motile actinomycete isolated from an anthill soil in Myanmar - Journal of Antibiotics

Virgisporangium myanmarense sp. nov., a novel motile actinomycete isolated from an anthill soil in Myanmar

The Journal of Antibiotics 70, 995 (October 2017). doi:10.1038/ja.2017.81

Authors: Hideki Yamamura, Shoya Miyazaki, Kodai Ikoma, Youji Nakagawa, Moriyuki Hamada, Misa Otoguro, Tomohiko Tamura, Katsuhiko Ando, Nyunt Phay & Masayuki Hayakawa

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Allostreptomyces indica sp. nov., isolated from India - Journal of Antibiotics

Allostreptomyces indica sp. nov., isolated from India

The Journal of Antibiotics 70, 1000 (October 2017). doi:10.1038/ja.2017.82

Authors: Amit Kumar Sahu, Syed Raziuddin Quadri, Dayanand Agasar, Jamal Al Ruwaili, Wen Jun-Li & Syed G Dastager

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Discovering potential Streptomyces hormone producers by using disruptants of essential biosynthetic genes as indicator strains - Journal of Antibiotics

Discovering potential Streptomyces hormone producers by using disruptants of essential biosynthetic genes as indicator strains

The Journal of Antibiotics 70, 1004 (October 2017). doi:10.1038/ja.2017.85

Authors: Nguyen B Thao, Shigeru Kitani, Hiroko Nitta, Toshiya Tomioka & Takuya Nihira

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A quinolinol-based small molecule with anti-MRSA activity that targets bacterial membrane and promotes fermentative metabolism - Journal of Antibiotics

A quinolinol-based small molecule with anti-MRSA activity that targets bacterial membrane and promotes fermentative metabolism

The Journal of Antibiotics 70, 1009 (October 2017). doi:10.1038/ja.2017.79

Authors: Dhanalakshmi R Nair, Ji Chen, João M Monteiro, Michaele Josten, Mariana G Pinho, Hans-Georg Sahl, Jimmy Wu & Ambrose Cheung

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Comparing the action of HT61 and chlorhexidine on natural and model Staphylococcus aureus membranes - Journal of Antibiotics

Comparing the action of HT61 and chlorhexidine on natural and model Staphylococcus aureus membranes

The Journal of Antibiotics 70, 1020 (October 2017). doi:10.1038/ja.2017.90

Authors: Alasdair TM Hubbard, Anthony RM Coates & Richard D Harvey

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A new anthracycline-type metabolite from Streptomyces sp. NEAU-L3 - Journal of Antibiotics

A new anthracycline-type metabolite from Streptomyces sp. NEAU-L3

The Journal of Antibiotics 70, 1026 (October 2017). doi:10.1038/ja.2017.95

Authors: Chang Lu, Yue Zhao, Wei-Qi Jia, Hui Zhang, Huan Qi, Wen-Sheng Xiang, Ji-Dong Wang & Xiang-Jing Wang

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New 12,8-Eudesmanolides from Eutypella sp. 1–15 - Journal of Antibiotics

New 12,8-Eudesmanolides from Eutypella sp. 1–15

The Journal of Antibiotics 70, 1029 (October 2017). doi:10.1038/ja.2017.89

Authors: Yuezhou Wang, Yue Wang, An-an Wu, Lei Zhang, Zhiyu Hu, Huiying Huang, Qingyan Xu & Xianming Deng

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Relationship Between Depressive Symptoms and Activity of Daily Living Dependence in Older Japanese: The Kurabuchi Study - American Geriatric Society

Background/Objectives

Few published studies have investigated the possibility of an association between depressive symptoms and dependence in activities of daily living (ADLs) in elderly adults. The objective of the study was to examine the association between depressive symptoms and future ADL dependence and to investigate how this association varies according to living circumstances and marital status.

Design

Community-based prospective observational study.

Setting

Kurabuchi Town, Gunma Prefecture, Japan.

Participants

A total of 769 residents aged 65 and older were surveyed at baseline in 2005/06; they were followed up annually during the 7.5-year study period (follow-up rate, 99% (n = 763).

Measurements

Presence of depressive symptoms was defined as a score of 2 or greater on the five-item Geriatric Depression Scale, and dependence in ADLs was defined as admission to a nursing home (institutionalization), eligibility for long-term care (LTC), or need for help in any of the six basic ADL items in the Katz Index of Independence in ADLs.

Results

Depressive symptoms were observed in 232 of the 763 participants (30.4%). Those with depressive symptoms were more prone to future ADL dependence than those without (adjusted risk ratio = 1.29, 95% confidence interval = 1.04–1.61). There was no clear evidence of any effect modification according to living circumstances or marital status on this association, although living with other people or marriage was found to be associated with greater risk of institutionalization.

Conclusion

Our findings suggest that depressive symptoms are associated with future ADL dependence and that living circumstances (except for institutionalization) and marital status do not affect the association.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities

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Federal judge orders Flawless Beauty to stop distributing unapproved drugs, recall certain products - FDA Press Releases

A federal judge ordered a New Jersey company that sold injectable skin whitening and other beauty products to stop selling and recall some of its products because they are unapproved new drugs that may be unsafe, putting consumers at risk.

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For Immediate Release: Silver Spring Foods, Inc. Voluntarily Recalling Waterfront Bistro Tartar Sauce Due To Possible Mislabeling and Undeclared Allergen - FDA Safety Alerts & Drug Recalls

Silver Spring is voluntarily recalling Waterfront Bistro Tartar Sauce because there is a chance an incorrect back label was attached to the product, which does not correctly identify ingredients that could pose an allergen risk; specifically egg.

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FDA selects participants for new digital health software precertification pilot program - FDA Press Releases

Today, the U.S. Food and Drug Administration announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA actions to bring relief to citizens of Puerto Rico; to help the island recover its considerable and economically vital medical product manufacturing base; and to prevent critical shortages of life-saving drugs made in Puerto Rico - FDA Press Releases

As an agency dedicated to promoting public health, and as fellow Americans, the staff at the U.S. Food and Drug Administration is doing all it can to support the immediate needs of Puerto Ricans following the destruction of Hurricane Maria. First and foremost, these efforts are focused around our mission driven responsibilities to ensure the safety of the medical products, blood and the food supply needed by residents of the island. Our efforts also encompass challenges that are unique to Puerto Rico. The island is home to a substantial base of manufacturing for critical medical products that supply the entire world. This industrial base is an important source of jobs and economic vitality for the island. It is a key to Puerto Rico’s economic recovery. The manufacturing facilities are also a pivotal source of critical medical products for the entire United States. Helping to bring these resources back in operation is an important goal of ours and of Puerto Rico’s.

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FDA conducts major global operation to protect consumers from potentially dangerous prescription drugs sold online - FDA Press Releases

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectable epinephrine products to American consumers.

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Age-Friendly Health Systems: Their Time Has Come - American Geriatric Society

This editorial comments on the article by Fulmer et al.

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Olfactory Dysfunction Predicts Subsequent Dementia in Older U.S. Adults - American Geriatric Society

Objectives

To investigate the relationship between olfactory dysfunction and subsequent diagnosis of dementia.

Design

Longitudinal study of a population representative of U.S. older adults.

Setting

Home interviews (National Social Life, Health, and Aging Project).

Participants

Men and women aged 57 to 85 (N = 2,906).

Measurements

Objective odor identification ability was measured at baseline using a validated five-item test. Five years later, the respondent, or a proxy if the respondent was too sick to interview or had died, reported physician diagnosis of dementia. The association between baseline olfactory dysfunction and an interval dementia diagnosis was tested using multivariate logistic regression, controlling for age, sex, race and ethnicity, education, comorbidities (modified Charlson Comorbidity Index), and cognition at baseline (Short Portable Mental Status Questionnaire).

Results

Older adults with olfactory dysfunction had more than twice the odds of having developed dementia 5 years later (odds ratio = 2.13, 95% confidence interval = 1.32–3.43), controlling for the above covariates. Having more odor identification errors was associated with greater probability of an interval dementia diagnosis (P = .04, 1-degree of freedom linear-trend test).

Conclusion

We show for the first time in a nationally representative sample that home-dwelling older adults with normal cognition and difficulty identifying odors face higher odds of being diagnosed with dementia 5 years later, independent of other significant risk factors. This validated five-item odor identification test is an efficient, low-cost component of the physical examination that can provide useful information while assessing individuals’ risk of dementia. Use of such testing may provide an opportunity for early interventions to reduce the attendant morbidity and public health burden of dementia.

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Screening Is Not Benign: Comment on “Olfactory Dysfunction Predicts Subsequent Dementia in Older US Adults” - American Geriatric Society

This Editorial comments on the article by Pinto et al.

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Global Sensory Impairment Predicts Morbidity and Mortality in Older U.S. Adults - American Geriatric Society

Objectives

To evaluate global sensory impairment (GSI, an integrated measure of sensory dysfunction) as a predictor of physical function, cognition, overall health, and mortality.

Design

Prospective study.

Setting

The National Social Life, Health, and Aging Project.

Participants

A national probability sample of 3,005 home-dwelling older U.S. adults assessed at baseline (2005–06) and 5-year follow-up (2010–11).

Measurements

Gait speed, activity, disability, cognition, overall health, 5-year mortality.

Results

At baseline, older adults with worse GSI were slower (Timed Up and Go times: odds ratio (OR) = 1.32, 95% confidence interval (CI) = 1.17–1.50) and had more activity of daily living deficits (≥2: OR = 1.26, 95% CI = 1.10–1.46). Five years later, they were still slower (timed walk: OR = 1.22, 95% CI = 1.05–1.42), had more disabilities (≥2 instrumental activities of daily living; OR = 1.45, 95% CI = 1.23–1.70), were less active (daytime activity according to accelerometry: β = −2.7, 95% CI = −5.2 to −0.2), had worse cognitive function (Montreal Cognitive Assessment; β = −0.64, 95% CI = −0.84 to −0.44), more likely to have poorer overall health (OR = 1.16, 95% CI = 1.03–1.31) and lose weight (>10%: OR = 1.31, 95% CI = 1.04–1.64), and have died (OR = 1.45, 95% CI = 1.19–1.76). All analyses were adjusted for relevant confounders at baseline, including age, sex, race and ethnicity, education, smoking, problem drinking, body mass index, comorbidities, and cognitive function.

Conclusion

GSI predicts impaired physical function, cognitive dysfunction, significant weight loss, and mortality 5 years later in older U.S. adults. Multisensory evaluation may identify vulnerable individuals, offering the opportunity for early intervention to mitigate adverse outcomes.

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America New York Ri Wang Food Group Issues Allergy Alert on Seafood Products - FDA Safety Alerts & Drug Recalls

America New York Ri Wang Food Group Co. ltd is recalling the following products because an allergenic ingredient, milk, was not declared in labelling. People who have an allergy or severe sensitivity to milk run the risk of serious of life-threatening allergic reaction if they consume these products.

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Effect of a Multimodal Educational Intervention on Use of Urinary Catheters in Hospitalized Individuals - American Geriatric Society

Background/Objectives

Urinary catheters are frequently used in hospital inpatients despite their association with greater morbidity and mortality. Reducing their unnecessary use can improve patient care. The objective of the current study was to determine the effectiveness of a multimodal nursing and physician education intervention to reduce the unnecessary use of urinary catheters in adult inpatients.

Design

Quasi-experimental interrupted time series study.

Setting

General internal medicine and surgical services of a large urban teaching hospital.

Participants

Admissions to the services under study during the study period (September 2009 to February 2013) (N = 21,550).

Intervention

A multimodal educational intervention incorporating educational posters, small-group teaching sessions, and changes to the hospital's electronic health records and nursing clinical documentation systems were introduced to nurses and physicians.

Measurements

Mean catheter days per patient (CDPP) and incidence of urinary catheterization, measured at monthly intervals throughout the study period.

Results

A decrease in mean CDPP of 5.6 and 6.5 days (P < .001) respectively was observed on the medical and surgical services following the intervention. The monthly incidence of catheterization decreased by 3.0 percentage points on medical units and 6.4 percentage points on surgical units immediately after the intervention, from an average of 14.5% and 15.0%, respectively, before the intervention. Similar degrees of improvement were observed for individuals of all ages, although older adults remained more likely to be catheterized. The effect persisted over nearly 3 years of observed follow-up.

Conclusions

A relatively simple multimodal educational intervention targeting nurses and physicians resulted in a significant and sustained reduction in CDPP and the proportion of participants catheterized.

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Addition of albumin to Traditional Risk Score Improved Prediction of Mortality in Individuals Undergoing Transcatheter Aortic Valve Replacement - American Geriatric Society

Objectives

The ability of the Society of Thoracic Surgeons (STS) and European System for Cardiac Operative Risk Evaluation (EuroSCORE)-2 scores to predict outcomes after transcatheter aortic valve replacement (TAVR) is insufficient. Frailty and serum albumin as a frailty marker were shown to correlate with prognosis after TAVR. We sought to evaluate the additive value of serum albumin to STS and EuroSCORE-2 scores to predict mortality in individuals undergoing TAVR.

Design

Retrospective analysis.

Setting

Tertiary-care hospital prospective registry.

Participants

Individuals who underwent TAVR (N = 426).

Measurements

We compared survival rates according to median baseline albumin levels (4 g/dL), STS score (4.5%), and EuroSCORE-2 (3.45%). Participants were divided into four groups according to median serum albumin and median STS and EuroSCORE-2 scores (high vs low), and 1-year survival rates were compared. A category-free net reclassification index (NRI) was calculated to compare the ability of a model of STS or EuroSCORE-2 alone to classify mortality risk with and without the addition of baseline serum albumin.

Results

Participants with low albumin levels had higher mortality (hazard ratio (HR) = 3.03, 95% confidence interval (CI) = 1.66–5.26, P < .001). Participants with low serum albumin and a high STS (HR = 4.55, 95% CI = 2.21–9.38, P < .001) or EuroSCORE-2 (HR = 2.72, 95% CI = 1.48–5.06, P = .001) score had higher mortality. Using NRI analysis, a model that included albumin in addition to STS correctly reclassified 42% of events (NRI = 0.58) and a model that included albumin in addition to EuroSCORE-2 correctly reclassified 44% of events (NRI = 0.64).

Conclusion

Serum albumin, as a marker of frailty, can significantly improve the ability of STS and EuroSCORE-2 scores to predict TAVR-related mortality.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricane’s Harvey and Irma - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s immediate steps to respond to Hurricane Maria and ongoing recovery efforts related to Hurricane’s Harvey and Irma

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Criminal and civil actions filed against Aegerion Pharmaceuticals Inc. - FDA Press Releases

Aegerion Pharmaceuticals Inc. agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) involving the introduction of misbranded Juxtapid (lomitapide) into interstate commerce.

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A Geriatric Geriatrician's Medication Error - American Geriatric Society

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Cognitive Trajectory Changes Over 20 Years Before Dementia Diagnosis: A Large Cohort Study - American Geriatric Society

Background/Objectives

Longitudinal studies have shown an increase in cognitive decline many years before clinical diagnosis of dementia. We sought to estimate changes, relative to “normal” aging, in the trajectory of scores on a global cognitive function test—the Cognitive Abilities Screening Instrument (CASI).

Design

A prospective cohort study.

Setting

Community-dwelling members of a U.S. health maintenance organization.

Participants

Individuals aged 65 and older who had no dementia diagnosis at baseline and had at least two visits with valid CASI test score (N = 4,315).

Measurements

Average longitudinal trajectories, including changes in trajectory before clinical diagnosis in those who would be diagnosed with dementia, were estimated for CASI item response theory (IRT) scores. The impact of sex, education level, and APOE genotype on cognitive trajectories was assessed.

Results

Increased cognitive decline relative to “normal” aging was evident in CASI IRT at least 10 years before clinical diagnosis. Male gender, lower education, and presence of ≥1 APOE ε4 alleles were associated with lower average IRT scores. In those who would be diagnosed with dementia, a trajectory change point was estimated at an average of 3.1 years (95% confidence interval 3.0-3.2) before clinical diagnosis, after which cognitive decline appeared to accelerate. The change point did not differ by sex, education level, or APOE ε4 genotype. There were subtle differences in trajectory slopes by sex and APOE ε4 genotype, but not by education.

Conclusion

Decline in average global cognitive function was evident at least 10 years before clinical diagnosis of dementia. The decline accelerated about 3 years before clinical diagnosis.

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Can a Left Ventricular Assist Device in Individuals with Advanced Systolic Heart Failure Improve or Reverse Frailty? - American Geriatric Society

Background/Objectives

Frailty, characterized by low physiological reserves, is strongly associated with vulnerability to adverse outcomes. Features of frailty overlap with those of advanced heart failure, making a distinction between them difficult. We sought to determine whether implantation of a left ventricular assist device (LVAD) would decrease frailty.

Design

Prospective, cohort study.

Setting

Five academic medical centers.

Participants

Frail individuals (N = 29; mean age 70.6 ± 5.5, 72.4% male).

Measurements

Frailty, defined as having 3 or more of the Fried frailty criteria, was assessed before LVAD implantation and 1, 3, and 6 months after implantation. Other domains assessed included quality of life, using the Kansas City Cardiomyopathy Questionnaire; mood, using the Patient Health Questionnaire; and cognitive function, using the Trail-Making Test Part B.

Results

After 6 months, three subjects had died, and one had undergone a heart transplant; of 19 subjects with serial frailty measures, the average number of frailty criteria decreased from 3.9 ± 0.9 at baseline to 2.8 ± 1.4 at 6 months (P = .003). Improvements were observed after 3 to 6 months of LVAD support, although 10 (52.6%) participants still had 3 or more Fried criteria, and all subjects had at least one at 6 months. Changes in frailty were associated with improvement in QOL but not with changes in mood or cognition. Higher estimated glomerular filtration rate at baseline was independently associated with a decrease in frailty.

Conclusion

Frailty decreased in approximately half of older adults with advanced heart failure after 6 months of LVAD support. Strategies to enhance frailty reversal in this population are worthy of additional study.

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Prevalence of Long-Term Opioid Use in Long-Stay Nursing Home Residents - American Geriatric Society

Background/Objectives

Overall and long-term opioid use among older adults have increased since 1999. Less is known about opioid use in older adults in nursing homes (NHs).

Design

Cross-sectional.

Setting

U.S. NHs (N = 13,522).

Participants

Long-stay NH resident Medicare beneficiaries with a Minimum Data Set 3.0 (MDS) assessment between April 1, 2012, and June 30, 2012, and 120 days of follow-up (N = 315,949).

Measurements

We used Medicare Part D claims to measure length of opioid use in the 120 days from the index assessment (short-term: ≤30 days, medium-term: >30–89 days, long-term: ≥90 days), adjuvants (e.g., anticonvulsants), and other pain medications (e.g., corticosteroids). MDS assessments in the follow-up period were used to measure nonpharmacological pain management use. Modified Poisson models were used to estimate adjusted prevalence ratios (aPR) and 95% confidence intervals (CI) for age, gender, race and ethnicity, cognitive and physical impairment, and long-term opioid use.

Results

Of all long-stay residents, 32.4% were prescribed any opioid, and 15.5% were prescribed opioids long-term. Opioid users (versus nonusers) were more commonly prescribed pain adjuvants (32.9% vs 14.9%), other pain medications (25.5% vs 11.0%), and nonpharmacological pain management (24.5% vs 9.3%). Long-term opioid use was higher in women (aPR = 1.21, 95% CI = 1.18–1.23) and lower in racial and ethnic minorities (non-Hispanic blacks vs whites: APR = 0.93, 95% CI = 0.90–0.94) and those with severe cognitive impairment (vs no or mild impairment, aPR = 0.82, 95% CI = 0.79–0.83).

Conclusion

One in seven NH residents was prescribed opioids long-term. Recent guidelines on opioid prescribing for pain recommend reducing long-term opioid use, but this is challenging in NHs because residents may not benefit from nonpharmacological and nonopioid interventions. Studies to address concerns about opioid safety and effectiveness (e.g., on pain and functional status) in NHs are needed.

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Chikungunya Virus Infection: Why Should U.S. Geriatricians Be Aware of It? - American Geriatric Society

Chikungunya virus (CHIKV) was until recently perceived only as a tropical disease. Since the first report of a case in Saint Martin Island in 2013, it has spread to South, Central, and North America. The first local transmission in the continental United States was reported in Florida in July 2014. CHIV infection is known to cause debilitating rheumatologic disease. Older adults are particularly susceptible to severe and chronic infection. Without an effective vaccine and antiviral therapy to prevent and control CHIKV, U.S. geriatricians could soon be confronted with major clinical, functional, and therapeutic challenges. After a general overview of CHIKV infection, this review will examine reasons why it has become such a threat to the United States and consider factors that contribute to the greater burden and effect of this disease in elderly adults. Consideration will be given to how aging and immunosenescence may contribute to CHIKV's atypical and more-severe clinical features in older adults. This review concludes with possible therapeutic approaches that best fit the unique needs of older adults, especially with regard to multimorbidity and polypharmacy.

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Atypical Clinical Presentations of Acute Phase Chikungunya Virus Infection in Older Adults - American Geriatric Society

Objectives

We aimed to determine whether the presentation of Chikungunya virus (CHIKV) infection differs between older and younger adults with regard to clinical form during the acute phase defined by the World Health Organization: acute clinical, atypical, and severe acute.

Design

Cross-sectional, retrospective.

Setting

University Hospital of Martinique.

Participants

Individuals aged 65 and older (n = 267, mean age 80.4 ± 87.9) who attended the emergency department with a positive biological diagnosis of CHIKV (reverse transcriptase polymerase chain reaction) between January and December 2014 and a randomly selected sample of individuals younger than 65 (n = 109, mean age 46.2 ± 12.7).

Results

Typical presentation was present in 8.2% of older adults and 59.6% of younger individuals (P < .001), atypical presentation in 29.6% of older adults and 5.6% of younger individuals (P < .001), and severe presentation in 19.5% of older adults and 17.4% of younger individuals (P = .65). One hundred fourteen (42.7%) of the older group and 19 (17.4%) of the younger group could not be classified in any category (absence of fever, absence of joint pain, or both) (P < .001).

Conclusion

Only 8.2% of the older adults presenting in the acute phase of CHIKV have typical forms, suggesting that the most-frequent clinical presentation of CHIKV in older adults differs from that in younger individuals.

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First Source Issues Allergy Alert On Undeclared Milk In Tasty Treats Nonpareils Milk Chocolate - FDA Safety Alerts & Drug Recalls

First Source of Pico Rivera, CA, is recalling Tasty Treats Nonpareils Milk Chocolate because it contains undeclared milk. 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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Nature Supplement Inc. Issues Voluntary Florida Recall of Vegetable Vigra Due to Undeclared Sildenafil - FDA Safety Alerts & Drug Recalls

Natures Supplement, Inc. is voluntarily recalling 260 bottles of VEGETABLE VIGRA, 200 mg capsules to the consumer level. FDA analysis found this product to be tainted with Sidenafil. Sildenafil is an FDA approved drug for the treatment of erectile dysfunction, the presence of Sildenafil in the Vegetable Vigra product renders it an unapproved drug for which safety and efficacy has not been established, therefore subject to recall.

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Death Wish Coffee Co. Announces Recall of Nitro Cold Brew Cans From Retailers, Online Sales - FDA Safety Alerts & Drug Recalls

Death Wish Coffee Co. (“Death Wish”), the Round Lake, N.Y.-based coffee producer known for producing the ‘World’s Strongest Coffee’, has initiated a recall its 11-oz Death Wish Nitro Cold Brew cans.

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Gadget Island, Inc. Dba Gear Isle Issues Voluntary Nationwide Recall of Dietary Supplements Due to Undeclared Active Pharmaceutical Ingredients. - FDA Safety Alerts & Drug Recalls

Newark, CA, Gadget Island, Inc. is voluntarily recalling to the consumer level. The products have been found to contain undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to promote the safe adoption of medication-assisted treatment for opioid addiction - FDA Press Releases

Medication-assisted treatment (MAT) – the use of medication combined with counseling and behavioral therapies – is one of the major pillars of the federal response to the opioid epidemic in this country. This type of treatment is an important tool that has the potential to help millions of Americans with an opioid use disorder regain control over their lives. In fact, patients receiving MAT cut their risk of death from all causes in half, according to the Substance Abuse and Mental Health Services Administration. Addressing the epidemic of opioid addiction is my highest public health priority. One element of that effort is promoting more widespread, safe adoption of MAT as a way to help more people overcome addiction.

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FDA clears first duodenoscope with disposable distal cap - FDA Press Releases

The U.S. Food and Drug Administration today cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.

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Novel and classical human astroviruses in stool and cerebrospinal fluid: comprehensive screening in a tertiary care hospital, Switzerland

Novel and classical human astroviruses in stool and cerebrospinal fluid: comprehensive screening in a tertiary care hospital, Switzerland

Emerging Microbes & Infections 6, e84 (September 2017). doi:10.1038/emi.2017.71

Authors: Samuel Cordey, Diem-Lan Vu, Marie-Celine Zanella, Lara Turin, Aline Mamin & Laurent Kaiser

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Cultivation of Anaplasma ovis in the HL-60 human promyelocytic leukemia cell line

Cultivation of Anaplasma ovis in the HL-60 human promyelocytic leukemia cell line

Emerging Microbes & Infections 6, e83 (September 2017). doi:10.1038/emi.2017.70

Authors: Ran Wei, Hong-Bo Liu, Frans Jongejan, Bao-Gui Jiang, Qiao-Cheng Chang, Xue Fu, Jia-Fu Jiang, Na Jia & Wu-Chun Cao

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Tick-borne encephalitis in Japan, Republic of Korea and China

Tick-borne encephalitis in Japan, Republic of Korea and China

Emerging Microbes & Infections 6, e82 (September 2017). doi:10.1038/emi.2017.69

Authors: Kentaro Yoshii, Joon Young Song, Seong-Beom Park, Junfeng Yang & Heinz-Josef Schmitt

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Zika virus infection confers protection against West Nile virus challenge in mice

Zika virus infection confers protection against West Nile virus challenge in mice

Emerging Microbes & Infections 6, e81 (September 2017). doi:10.1038/emi.2017.68

Authors: Ángela Vázquez-Calvo, Ana-Belén Blázquez, Estela Escribano-Romero, Teresa Merino-Ramos, Juan-Carlos Saiz, Miguel A Martín-Acebes & Nereida Jiménez de Oya

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Self-Reported Function More Informative than Frailty Phenotype in Predicting Adverse Postoperative Course in Older Adults - American Geriatric Society

Background/Objective

Current preoperative assessment tools such as the American College of Surgeons Surgical Risk Calculator (ACS Calculator) are suboptimal for evaluating older adults. The objective was to evaluate and compare the performance of the ACS Calculator for predicting risk of serious postoperative complications with the addition of self-reported physical function versus a frailty score.

Design

Prospective cohort.

Setting

Two tertiary care academic medical centers in Massachusetts.

Participants

Individuals aged 65 and older undergoing any surgery with a risk of serious complication of 5% or greater (N = 403).

Measurements

We measured self-reported physical function using the Late-Life Function and Disability Instrument (LLFDI FUNCTION) and frailty phenotype (FP), which has a score ranging from 0 to 5 based on slow gait speed, weak handgrip, exhaustion, weight loss, or low activity. Using c-statistic and net classification improvement (NRI), we then analyzed capability of LLFDI-FUNCTION versus FP to improve the ACS Calculator for predicting an adverse postoperative course (serious complication, discharge to nursing home, readmission, death within 30 days of surgery). Increase in c-statistic and net reclassification improvement (NRI) for LLFDI-FUNCTION versus FP in addition to the ACS Calculator for predicting an adverse postoperative course (serious complication, discharge to nursing home, readmission, death within 30 days of surgery)

Results

Over 30 days, 26% of participants developed an adverse postoperative course. The increase in c-statistic for the ACS Calculator (baseline value 0.645) was slightly greater with LLFDI-FUNCTION (0.076) than with FP (0.058), with a bootstrapped difference in c-statistic of 0.005 (95% confidence interval = 0.002–0.007). NRI was also better with LLFDI-FUNCTION.

Conclusion

The LLFDI-FUNCTION predicted postoperative complications slightly better than the FP. Further studies are needed to confirm these findings and validate the use of the LLFDI-FUNCTION with the ACS Calculator for preoperative assessments of older adults.

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Nocturia is Associated with Poor Sleep Quality Among Older Women in the Study of Osteoporotic Fractures - American Geriatric Society

Objectives

(1) To examine relationships between frequency of nocturia and self-reported sleep quality and objective sleep measures in older women, and (2) to estimate the amount of variation in sleep measures that is specifically attributable to frequency of nocturia.

Design and setting

Secondary, cross sectional analysis of the multicenter prospective cohort Study of Osteoporotic Fractures (SOF).

Participants

Community-dwelling women aged ≥80 years.

Measurements

Frequency of nocturia in the previous 12 months, Pittsburgh Sleep Quality Index sleep quality subscale, and actigraphy-measured wake after sleep onset (WASO) and total sleep time (TST).

Results

Of 1,520 participants, 25% (n = 392) reported their nocturia frequency was 3–4 times/night and an additional 60% (n = 917) reported their nocturia frequency was 1–2 times/night. More frequent nocturia was associated with poor sleep quality (3–4/night: 26.8% reported fairly bad or very bad sleep quality; 1–2/night: 14.7%; 0/night: 7.7%; P < .001) and longer WASO (3–4/night: 89.8 minutes; 1–2/night: 70.6; 0/night: 55.5; P < .001). In nested regression models, a nocturia frequency of 3–4/night quadrupled the odds of poor sleep quality (odds ratio: 4.26 [95% CI 1.65, 11.01]; P = .003) and was associated with a 37-minute worsening in WASO (95% CI 26.0, 49.0; P < .001). Frequency of nocturia explained an additional 6% variation in WASO, above and beyond demographic, medical/psychiatric conditions, and medication factors (∆R² = 0.06).

Conclusions

Nocturia is common among octogenarian and nonagenarian women and is independently associated with poor sleep quality and longer wake time at night. Interventions that improve nocturia may be useful in improving sleep quality and wake time at night.

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Las Nuevas Tarjetas de Medicare Ya Llegarán Pronto - CMS Blog

Por: Seema Verma, Administradora de los CMS

Como podría haber escuchado ya, o quizás ya vio un comercial de televisión, los Centros de Servicios de Medicare y Medicaid pronto emitirán a cada beneficiario de Medicare una nueva Tarjeta de Medicare, sin números de Seguro Social, para prevenir el fraude, mantener seguros los fondos de los contribuyentes, y para asegurar que siempre ponemos las necesidades de los pacientes primero.

Desafortunadamente los criminales están cada vez más interesados en las personas de 65 años o más para el robo de identidad médica, incluso cuando alguien usa ilegalmente el número de Medicare de otra persona. Un ladrón de identidad puede facturarle a Medicare por servicios costosos que nunca fueron proporcionados o cobrar más por los servicios proporcionados. Esto puede resultar en ambigüedades en los registros médicos, lo que puede significar el retraso en la atención o servicios negados para los pacientes y también impacta los fondos de los contribuyentes.

Para ayudar a combatir esto, les enviaremos a todos los beneficiarios de Medicare una nueva tarjeta con un número único asignado al azar. Cuenta con once caracteres, una combinación de números y letras mayúsculas.

Debido a que el número se genera al azar, no hay conexión a otra información de identificación personal. Este nuevo número reemplazará al número actual basado en el Seguro Social, y está diseñado para proteger la información personal de los beneficiarios de Medicare.

Comenzaremos a enviar por correo las recién diseñadas tarjetas de Medicare en abril de 2018, y reemplazaremos todas las tarjetas antes de abril de 2019. Si usted es beneficiario de Medicare o pronto lo será, no tendrá que hacer nada y podrá comenzar a usar su nueva tarjeta tan pronto como la reciba.

Cuando reciba su nueva tarjeta, le pediremos que destruya su tarjeta de Medicare de una manera segura. Asegúrese de traer la nueva tarjeta a las citas de sus médicos, y mantenga siempre confidencial su nuevo número. Esto ayudará a proteger su identidad personal y prevenir el fraude de identidad médica porque los ladrones de identidad no pueden facturar a Medicare sin un número de Medicare válido. Además, usted y sus proveedores de atención médica podrán utilizar herramientas seguras en línea que estamos desarrollando y que brindarán acceso rápido a su número de Medicare cuando sea necesario.

Usted va a escuchar mucho más acerca de esta iniciativa en las próximas semanas y meses, y también estamos ayudando a los médicos y otros proveedores de atención médica a prepararse para el cambio. Queremos hacer este proceso tan fácil como sea posible para todos los involucrados. Sobre todo, queremos que las personas con Medicare y los proveedores de atención médica sepan estos cambios con anticipación y tengan la información necesaria para asegurar una transición fácil a la nueva tarjeta.

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New Medicare Cards are Coming Soon - CMS Blog

By:  Seema Verma, CMS Administrator

As you may have heard, or perhaps you’ve seen a recent TV commercial, the Centers for Medicare & Medicaid Services will soon be issuing every Medicare beneficiary a new Medicare Card, without Social Security Numbers, to prevent fraud, fight identity theft, and keep taxpayer dollars safe, and to help ensure that we always put the needs of patients first.

It’s unfortunate that criminals are increasingly targeting people age 65 or older for medical identity theft, including when someone illegally uses another person’s Medicare number. An identity thief may bill Medicare for expensive services that were never provided or overbill for provided services. This can lead to inaccuracies in medical records, which can mean delayed care or denied services for patients and impacts taxpayer funding.

To help combat this, we’ll be sending all Medicare beneficiaries a new card with a unique, randomly-assigned Medicare number.  It will consist of eleven characters, a combination of numbers and uppercase letters.

Because it is randomly generated, there is no connection to any other personal identifying information. This new number will replace the Social Security-based number currently used on all Medicare cards, and it’s designed to protect the personal information of Medicare beneficiaries.

We’ll begin mailing the newly designed Medicare cards in April 2018, and we’ll replace all cards by April 2019. If you’re a Medicare beneficiary, or soon will be, you don’t need to do anything, and you can start using your new card as soon as you get it.

When you get your new card, we’ll ask you to safely and securely destroy your current Medicare card.  Make sure you bring the new card to your doctors’ appointments, and always keep your new number confidential.  This will help protect your personal identity and prevent medical identity fraud because identity thieves can’t bill Medicare without a valid Medicare number. Additionally, you and your health care providers will be able to use secure online tools that we’re developing that will support quick access to your Medicare number when needed.

You’ll be hearing a lot more about this initiative in the coming weeks and months, and we’re also helping doctors and other healthcare providers get ready for the change.  We want to make this process as easy as possible for everyone involved. Above all, we want to ensure that people with Medicare and healthcare providers know about these changes well in advance and have the information needed to ensure an easy transition to the new card.

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Statement from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by Hurricanes Harvey and Irma and FDA’s work with farmers affected by the storms - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., about crops impacted by Hurricanes Harvey and Irma and FDA’s work with farmers affected by the storms

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FDA approves new treatment for adults with relapsed follicular lymphoma - FDA Press Releases

The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.

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FDA approves first biosimilar for the treatment of cancer - FDA Press Releases

The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

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Natural Grocers Issues Recall on Organic Deglet Dates Due to Mislabeling and Undeclared Allergens - FDA Safety Alerts & Drug Recalls

Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand Organic Deglet Noor Dates Pitted because it may contain undeclared coconut, an allergen. People who have an allergy or severe sensitivity to coconut run the risk of a serious or life-threatening allergic reaction if they consume this product.

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FDA permits marketing of mobile medical application for substance use disorder - FDA Press Releases

Today, the U.S. Food and Drug Administration permitted marketing of the first mobile medical application to help treat substance use disorders (SUD). The Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence.

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OriGen Biomedical Issues Nationwide Recall of OriGen VV28F Reinforced Dual Lumen ECMO Catheters - FDA Safety Alerts & Drug Recalls

On August 2, 2017, OriGen Biomedical initiated a nationwide recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters. These VV28F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage.

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Cherry Valley Marketplace Issues Allergy Alert on Undeclared Milk Allergens in “Cherry Valley Vanilla Cupcakes” and “Cherry Valley Chocolate Cupcakes” - FDA Safety Alerts & Drug Recalls

Cherry Valley Marketplace, West Hempstead, NY, is recalling its 12-ounce packages of CHERRY VALLEY VANILLA CUPCAKES and CHERRY VALLEY CHOCOLATE CUPCAKES because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product.

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Medtronic Announces Voluntary Recall of Diabetes Infusion Sets - FDA Safety Alerts & Drug Recalls

Medtronic plc (NYSE:MDT) announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors.

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Bravo Produce Inc. Retira Maradol Papaya de Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V. Por posible riesgo a la salud - FDA Safety Alerts & Drug Recalls

Bravo Produce Inc de San Ysidro, está retirando Maradol Papaya, cultivadas por Productores y Exportadores de Carica Papaya de Tecoman y Costa Alegre SPR de RL y empacadas por Frutas Selectas de Tijuana, S. de R.L. de C.V., como manera preventiva, debido a que dicho producto ha probado positivo para Salmonella, es de suma importancia mencionar que dicha bacteria puede afectar a niños, ancianos y personas con sistemas inmunológicos débiles. Los síntomas a experimentar son fiebre, diarrea, náusea, vómito y dolor abdominal. En raras circunstancias, la infección por Salmonella puede resultar en el organismo entrando en el torrente sanguíneo y la producción de enfermedades graves, como las infecciones arteriales (es decir, los aneurismas infectados), endocarditis y artritis.

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Prevalence and Correlates of Elder Abuse in São Paulo and Rio de Janeiro - American Geriatric Society

Objectives

To assess the prevalence of elder abuse and to investigate potential sociodemographic, health behavior, and medical correlates.

Design

Cross-sectional data were collected in face-to-face assessments.

Setting

São Paulo and Rio de Janeiro, Brazil.

Participants

Individuals aged 60 to 75.

Measurements

Information on elder abuse was obtained using the Brazil-adapted, nine-item Hwalek-Sengstock Elder Abuse Screening Test. Sampling design–adjusted descriptive statistics and logistic regression were used in analyses.

Results

The overall prevalence of abuse was 14.4% (n = 46/259, 95% confidence interval (CI) = 9.82–20.61) in São Paulo and 13.3% (n = 27/197, 95% CI = 8.76–19.74) in Rio de Janeiro. Unadjusted analyses indicated that poor education, low physical activity, unemployment, heart disease, and psychiatric problems were associated with abuse, but in adjusted analyses, self-reported elder abuse was significantly associated only with psychiatric problems (São Paulo: OR = 4.48, 95% CI = 1.75–11.45; Rio de Janeiro: OR = 21.61, 95% CI = 6.39–73.14).

Conclusion

Elder abuse is prevalent in São Paulo and Rio de Janeiro, but whether concomitants of abuse are cause, effect, or both is unclear because this was a cross-sectional study. These findings highlight the importance of the problem, as well as the need to develop measures to increase awareness, facilitate prevention, and fight against abuse of elderly adults.

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Racial Differences in the Association Between Apolipoprotein E Risk Alleles and Overall and Total Cardiovascular Mortality Over 18 Years - American Geriatric Society

Objectives

To examine the difference in the association between apolipoprotein (APO)E allele and overall and cardiovascular mortality between African Americans (AAs) and European Americans (EAs).

Design

Longitudinal, cohort study of 18 years.

Setting

Biracial urban US population sample.

Participants

4,917, 68% AA and 32% EA.

Measurements

APOE genotype and mortality based on National Death Index.

Results

A higher proportion of AAs than of EAs had an APOE ε2 allele (ε2ε2/ε2ε3/ε2ε4; 22% vs 13%) and an APOE ε4 allele (ε3ε4/ε4ε4; 33% vs 24%). After adjusting for known risk factors, the risk of mortality was 19% less with the APOE ε2 allele (hazard ratio (HR) = 0.81, 95% confidence interval (CI) = 0.76–0.87), and the risk of cardiovascular mortality was 35% less (HR = 0.65, 95% CI = 0.58–0.76) than with the ε3ε3 allele. The risk of mortality was 10% greater with the APOE ε4 allele (HR = 1.10, 95% CI = 1.04–1.16), and the risk of cardiovascular mortality was 20% greater (HR = 1.20, 95% CI = 1.07–1.29) than with the ε3ε3 allele. No difference in the association between APOE allele and mortality was observed between AAs and EAs.

Conclusion

The APOE ε4 allele increased the risk of overall and cardiovascular mortality, whereas the APOE ε2 allele decreased the risk of overall and cardiovascular mortality. There was no racial difference in the association between these alleles and mortality.

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Coborn’s, Inc.’s Issues Recall of American Rye Bread and Caraway Rye Bread Due To Undeclared Allergens - FDA Safety Alerts & Drug Recalls

Coborn's, Inc. is recalling packages of its American Rye Bread and Caraway Bread, which contain undeclared allergens (milk, soy and egg) as a result of an update to the ingredient profile from the manufacturer of the base. People who have an allergy or severe sensitivity to Milk, Soy, and/or Eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

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Statins for Primary Prevention of Cardiovascular Events and Mortality in Older Men - American Geriatric Society

Background/Objectives

We sought to determine whether statin use for primary prevention is associated with a lower risk of cardiovascular events or mortality in older men.

Design

Prospective cohort study.

Setting

Physicians’ Health Study participants.

Participants

7,213 male physicians ≥70 years without a history of cardiovascular disease (CVD).

Measurements

Multivariable propensity score for statin use with greedy matching (1:1) to minimize confounding by indication.

Results

Median baseline age was 77 (70–102), median follow-up was 7 years. Non-users were matched to 1,130 statin users. Statin use was associated with an 18% lower risk of all-cause mortality, HR 0.82 (95% CI 0.69–0.98) and non-significant lower risk of CVD events, HR 0.86 (95% CI 0.70–1.06) and stroke, HR 0.70 (95% CI 0.45–1.09). In subgroup analyses, results did not change according to age group at baseline (70–76 or >76 years) or functional status. There was a suggestion that those >76 at baseline did not benefit from statins for mortality, HR 1.14 (95% CI 0.89–1.47), compared to those 70–76 at baseline, HR 0.83 (95% CI 0.61–1.11); however the CIs overlap between the two groups, suggesting no difference. Statin users with elevated total cholesterol had fewer major CVD events than non-users, HR 0.68 (95% CI 0.50–0.94) and HR 1.43 (95% CI 0.99–2.07)), respectively.

Conclusions

Statin use was associated with a significant lower risk of mortality in older male physicians ≥70 and a nonsignificant lower risk of CVD events. Results did not change in those who were >76 years at baseline or according to functional status. There was a suggestion that those with elevated total cholesterol may benefit. Further work is needed to determine which older individuals will benefit from statins as primary prevention.

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Statins for Primary Prevention in Older Adults: An Unresolved Conundrum - American Geriatric Society

This editorial comments on the article by Orkaby et al.

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Proton Pump Inhibitors and Risk of Pneumonia in Individuals with Dementia - American Geriatric Society

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Nursing Home Use Across The Spectrum of Cognitive Decline: Merging Mayo Clinic Study of Aging With CMS MDS Assessments - American Geriatric Society

Background/objectives

Objective, complete estimates of nursing home (NH) use across the spectrum of cognitive decline are needed to help predict future care needs and inform economic models constructed to assess interventions to reduce care needs.

Design

Retrospective longitudinal study.

Setting

Olmsted County, MN.

Participants

Mayo Clinic Study of Aging participants assessed as cognitively normal (CN), mild cognitive impairment (MCI), previously unrecognized dementia, or prevalent dementia (age = 70–89 years; N = 3,545).

Measurements

Participants were followed in Centers for Medicare and Medicaid Services (CMS) Minimum Data Set (MDS) NH records and in Rochester Epidemiology Project provider-linked medical records for 1-year after assessment of cognition for days of observation, NH use (yes/no), NH days, NH days/days of observation, and mortality.

Results

In the year after cognition was assessed, for persons categorized as CN, MCI, previously unrecognized dementia, and prevalent dementia respectively, the percentages who died were 1.0%, 2.6%, 4.2%, 21%; the percentages with any NH use were 3.8%, 8.7%, 19%, 40%; for persons with any NH use, median NH days were 27, 38, 120, 305, and median percentages of NH days/days of observation were 7.8%, 12%, 33%, 100%. The year after assessment, among persons with prevalent dementia and any NH use, >50% were a NH resident all days of observation. Pairwise comparisons revealed that each increase in cognitive impairment category exhibited significantly higher proportions with any NH use. One-year mortality was especially high for persons with prevalent dementia and any NH use (30% vs 13% for those with no NH use); 58% of all deaths among persons with prevalent dementia occurred while a NH resident.

Conclusions

Findings suggest reductions in NH use could result from quality alternatives to NH admission, both among persons with MCI and persons with dementia, together with suitable options for end-of-life care among persons with prevalent dementia.

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Reply to: Re: Proton Pump Inhibitor Usage and Risk of Pneumonia in Dementia Patients - American Geriatric Society

This letter comments on the letter by Muhammet Cemal Kizilarslanoglu.

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Bravo Produce Inc. Recalls Maradol Papaya from Productores Y Exportadores De Carica Papaya De Tecomán Y Costa Alegre SPR of RL and Packed by Frutas Selectas De Tijuana, S. De R.L. De C.V. Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Bravo Produce Inc. of San Ysidro, is withdrawing Maradol Papaya, grown by Productores y Exportadores de Carica Papaya de Tecomán y Costa Alegre SPR of RL and packed by Frutas Selectas de Tijuana, S. de RL de CV, as a preventive measure, because the product has tested positive for Salmonella by exams done by FDA. It is extremely important to mention that this bacterium can affect children, elderly and people with weak immune systems. Symptoms are fever, diarrhea, nausea, vomiting and abdominal pain.

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Simply Fresh Foods, Inc. Issues Allergy Alert on Undeclared Milk in Single Serve Cups of San Francisco Seafood Salad Made with Greek Yogurt - FDA Safety Alerts & Drug Recalls

Simply Fresh Foods, Inc. of Buena Park, CA is recalling 272 cases of one specific lot of its 4-4 ounce packages of "San Francisco Seafood Salad Made with Greek Yogurt" bearing a UPC bar code of 47502 19701 because the individual cups inside the carton may be mislabeled as Seafood Salad with Real Mayonnaise and does not declare "milk". The outer carton is correct and has the correct ingredient statement which declares "milk". People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

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Garden of Life LLC Issues Recall of Baby Organic Liquid Formula - FDA Safety Alerts & Drug Recalls

Today, Garden of Life, LLC, is issuing a voluntary precautionary recall of its new supplement for infants, Baby Organic Liquid, because the product, as labeled, includes directions for use that may be misinterpreted. The company is concerned that if not administered precisely following the labeled instructions, the product may present difficulties in swallowing and potentially pose a choking hazard due to the thickness of the liquid.

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The Association Between the Use of Zolpidem and the Risk of Alzheimer's Disease Among Older People - American Geriatric Society

Objectives

To evaluate the association between zolpidem use and the risk of Alzheimer's disease among older people.

Design

A retrospective cohort study using data from 2001 to 2011 from the National Health Insurance Research Database.

Setting

Taiwan.

Participants

A total of 6,922 patients aged 65 years or older enrolled from January 2002 to December 2004 (the enrollment period).

Intervention (Exposure)

Zolpidem users were identified as patients who used zolpidem during the enrollment period. The index date was the date of the first zolpidem prescription. Dosage of zolpidem use was defined using cumulative defined daily dose (cDDD) based on the cumulative dosage that patients took within one year after the index date (grouped as: less than 28, 28–90, 91–180, and more than 180 cDDD).

Measurements

The occurrence of Alzheimer's disease was defined as the time period from the end of one year after the index date to the date of the Alzheimer's disease diagnosis. The propensity score was used to adjust the measured confounders of Alzheimer's disease. Cox proportional hazards models were used to evaluate the association between zolpidem use and the incidence of Alzheimer's disease.

Results

Zolpidem users with a high cumulative dose (>180 cDDD) in the first year after initiation had a significantly greater risk of Alzheimer's disease than non-zolpidem users (HR = 2.97, 95% CI = 1.61–5.49) and low cumulative dose (<28 cDDD) users (HR = 4.18, 95% CI = 1.77–9.86).

Conclusion

We found the use of a high cumulative dose of zolpidem was associated with an increased risk of Alzheimer's disease among older people living in Taiwan. It is advised to use caution when considering long-term use of zolpidem in older patients.

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Co-creation by the ABIM Geriatric Medicine Board and the AGS – Helping Move Geriatrics Forward - American Geriatric Society

The American board of internal medicine (ABIM) establishes standards for physicians. The American geriatrics society (AGS) is a not-for-profit membership organization of nearly 6,000 health professionals devoted to improving the health, independence, and quality of life of all older people. Beginning in 2013, ABIM redesigned its governance structure, including the role of the specialty boards. Specialty boards are charged with responsibilities for oversight in four main areas: (1) the assessments used in initial certification and maintenance of certification (MOC); (2) medical knowledge self-assessment and practice assessment in the specialty; (3) building relationships with relevant professional societies and other organizational stakeholders; and (4) issues related to training requirements for initial certification eligibility within the specialty. The aim of this paper is to inform the geriatrics community regarding the function of geriatric medicine board (GMB) of the ABIM, and to invite the geriatrics community to fully engage with and leverage the GMB as a partner to: (1) develop better certification examinations and processes, identifying better knowledge and practice assessments, and in establishing appropriate training and MOC requirements for geriatric medicine; (2) leverage ABIM assets to conduct applied research to guide the field in the areas of training and certification and workforce development in geriatric medicine; (3) make MOC relevant for practicing geriatricians. Active engagement of the geriatrics community with ABIM and the GMB will ensure that certification in geriatric medicine provides the greatest possible value and meaning to physicians, patients, and the public.

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Product Recall By Wegmans Assorted Muffins 4 Pack - FDA Safety Alerts & Drug Recalls

The assorted muffin four pack may include a banana nut muffin containing walnuts, an allergen not listed on the label. People who have an allergy or sensitivity to nuts should not consume this product.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy

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Genentech Issues Voluntary Nationwide Recall of Three Lots of Activase® (Alteplase)-100 mg Due to Lack of Sterility Assurance of the Sterile Water for Injection - FDA Safety Alerts & Drug Recalls

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), is voluntarily recalling three lots of Activase® (alteplase) 100mg vials, that were co-packaged with Sterile Water for Injection, to the hospital level. The vials of Sterile Water for Injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100 mg, may be cracked or chipped at the neck of the vial and leaking.

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The Age-Friendly Health System Imperative - American Geriatric Society

The unprecedented changes happening in the American healthcare system have many on high alert as they try to anticipate legislative actions. Significant efforts to move from volume to value, along with changing incentives and alternative payment models, will affect practice and the health system budget. In tandem, growth in the population aged 65 and older is celebratory and daunting. The John A. Hartford Foundation is partnering with the Institute for Healthcare Improvement to envision an age-friendly health system of the future. Our current prototyping for new ways of addressing the complex and interrelated needs of older adults provides great promise for a more-effective, patient-directed, safer healthcare system. Proactive models that address potential health needs, prevent avoidable harms, and improve care of people with complex needs are essential. The robust engagement of family caregivers, along with an appreciation for the value of excellent communication across care settings, is at the heart of our work. Five early-adopter health systems are testing the prototypes with continuous improvement efforts that will streamline and enhance our approach to geriatric care.

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Surveillance for highly pathogenic influenza A viruses in California during 2014–2015 provides insights into viral evolutionary pathways and the spatiotemporal extent of viruses in the Pacific Americas Flyway

Surveillance for highly pathogenic influenza A viruses in California during 2014–2015 provides insights into viral evolutionary pathways and the spatiotemporal extent of viruses in the Pacific Americas Flyway

Emerging Microbes & Infections 6, e80 (September 2017). doi:10.1038/emi.2017.66

Authors: Andrew M Ramey, Nichola J Hill, Troy Cline, Magdalena Plancarte, Susan De La Cruz, Michael L Casazza, Joshua T Ackerman, Joseph P Fleskes, T Winston Vickers, Andrew B Reeves, Frances Gulland, Christine Fontaine, Diann J Prosser, Jonathan A Runstadler & Walter M Boyce

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