Major Need of Foreign Medical Graduate Physicians for Insights into Older Americans - American Geriatric Society

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Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products

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FDA, USDA partner to improve coordination, bolster collaboration - FDA Press Releases

FDA Commissioner Dr. Scott Gottlieb and USDA Secretary Perdue launched an effort today to increase collaboration, efficiency and effectiveness, and provide clarity to food producers.

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Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA's Cooperation to Restore Access for Patients with Medical Necessity - FDA Safety Alerts & Drug Recalls

Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.

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Panera Bread Preemptively Recalls All 2 oz. and 8 oz. Cream Cheese Products - FDA Safety Alerts & Drug Recalls

While there have been no reported illnesses, out of an abundance of caution, Panera Bread is conducting a nationwide preemptive, voluntary recall of all 2 oz. and 8 oz. cream cheese products sold in its U.S. bakery-cafes. This recall was initiated after samples of one variety of 2 oz. cream cheese from a single production day showed a positive result for the presence of Listeria monocytogenes. Tests on cream cheese samples manufactured both before and after the production run in question have all come back negative.

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Battles Worth Fighting - American Geriatric Society

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FDA approves new treatment for certain digestive tract cancers - FDA Press Releases

FDA approves first radioactive drug for a certain type of digestive tract cancer called GEP-NETs

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Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s strengthened commitments to humane and judicious animal research and the termination of a nicotine study - FDA Press Releases

FDA strengthens commitments to humane and judicious animal research and the termination of a nicotine study

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Bulletproof 360, Inc. Issues Allergy Alert on Undeclared Milk in Collagen Protein Dietary Supplement - FDA Safety Alerts & Drug Recalls

Out of an abundance of caution, Bulletproof 360, Inc. is voluntarily recalling one lot #1017088 of Bulletproof Collagen Protein dietary supplement due to 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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Albuminuria and Cerebral Small Vessel Disease: A Systematic Review and Meta-Analysis - American Geriatric Society

Objectives

To determine whether albuminuria, a marker of systemic endothelial dysfunction, is associated with cerebral small vessel disease (SVD).

Design

Systematic review following the Meta-analyses Of Observational Studies in Epidemiology guidelines; independent reviewers searched Pubmed/Medline and Scopus, data were extracted, studies were evaluated on quality, and random-effects models were implemented for meta-analysis.

Setting

Observational studies quantifying an association between albuminuria and cerebral SVD.

Participants

Adults.

Measurements

Magnetic resonance imaging–defined markers of cerebral SVD; white matter hyperintensities (WMHs), lacunar infarcts (LIs), cerebral microbleeds (CMBs), and enlarged perivascular spaces (EPVSs).

Results

Of 31 eligible studies comprising 23,056 participants identified, 27 were included in quantitative synthesis. Most of the studies were cross-sectional and of varying quality. On meta-analysis, albuminuria was associated with greater risk of WMHs (odds ratio (OR) = 1.70, 95% confidence interval (CI) = 1.43–2.01; 13,548 subjects, 2,665 cases; I² = 44%), LIs (OR = 1.86, 95% CI = 1.49–2.31; 12,857 subjects, 998 cases; I² = 27%), CMBs (OR = 1.78, 95% CI = 1.30–2.43; 7,645 subjects; 748 cases; I² = 39%), and EPVSs in the basal ganglia (OR = 1.78, 95% CI = 1.02–3.09; 1,388 subjects, 399 cases; I² = 37%) and centrum semiovale (OR = 3.27, 95% CI = 1.49–7.20; 1,146 subjects, 460 cases; I² = 66%). Sensitivity analyses for high-quality and general population studies, but also studies controlling for cardiovascular disease risk factors and renal function, confirmed the findings and resolved the moderate heterogeneity and publication bias that were evident in the overall analyses.

Conclusion

Albuminuria is independently associated with cerebral SVD, indicating shared microvascular pathology in the kidney and the brain. The results suggest that peripheral systemic microvascular disease biomarkers could be useful in the evaluation of brain microvascular damage.

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Recombinant yeast and human cells as screening tools to search for antibacterial agents targeting the transcription termination factor Rho - Journal of Antibiotics

Recombinant yeast and human cells as screening tools to search for antibacterial agents targeting the transcription termination factor Rho

Recombinant yeast and human cells as screening tools to search for antibacterial agents targeting the transcription termination factor Rho, Published online: 25 January 2018; doi:10.1038/s41429-017-0007-x

Recombinant yeast and human cells as screening tools to search for antibacterial agents targeting the transcription termination factor Rho

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Protective Effect of Denosumab on Bone in Older Women with Primary Hyperparathyroidism - American Geriatric Society

Objectives

To determine the effect of denosumab, which is used in primary osteoporosis (PO), in primary hyperparathyroidism (PHPT)-related osteoporosis.

Design

Retrospective, longitudinal study.

Setting

Outpatient osteoporosis clinic.

Participants

Older women with PHPT (78.6 ± 5.5) (n = 25) and PO (78.8 ± 5.2) (n = 25) matched on age, body mass index, familial history of hip fracture, femoral bone mineral density (BMD), and personal history of fragility fractures.

Intervention

Twenty-four months of denosumab therapy.

Measurements

We assessed the calcium-phosphorus metabolism parameters; BMD at the lumbar spine (LS), femoral neck (FN), and total hip (TH) using dual X-ray absorptiometry; and morphometric vertebral fractures using radiographs in all subjects at baseline and after 24 months. Changes in BMD and total alkaline phosphatase (ALP) activity were considered significant if they were greater than the least significant change (LS 2.8%, FN 5.9%, TH 4.8%, ALP –22%) and were expressed as percentage difference between end of follow-up and baseline (Δ).

Results

After 24 months, women with PHPT had greater ΔALP (−30.6 ± 11.3), ΔFN (5.6 ± 4.8), and ΔTH (4.8 ± 4.4) than those with PO (ΔALP −21.4 ± 13.1, ΔFN 2.9 ± 4.8, ΔTH 1.2 ± 4.1, P < .05 for all comparisons). A significant increase in BMD was more frequent in women with PHPT (92%) than in those with PO (52%, P < .05) and it was 13.4 times as likely in women with PHPT as in those with PO (P = .02), regardless of possible confounders. Two subjects in each group had an incident fracture.

Conclusions

Denosumab therapy is effective in older women with PHPT-related osteoporosis.

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FDA, FTC warn companies for selling illegal, unapproved opioid cessation products using deceptive claims - FDA Press Releases

FDA and FTC issued joint warning letters to the marketers and distributors of 12 opioid cessation products, for illegally marketing unapproved products with claims about their ability to help in the treatment of opioid addiction and withdrawal

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Products Pacheco Inc Issues Allergy Alert For Undeclared Wheat, Soy, Egg, Milk and Undeclared Artificial Coloring in its Bakery Products - FDA Safety Alerts & Drug Recalls

PRODUCTS PACHECO INC. in Bayamón, Puerto Rico, is recalling the following products of PACHECO brand because they may contain undeclared allergens: Wheat, Soy, Egg, Milk and artificial coloring not listed: Red#40, Yellow#5, Yellow#6. People who have allergies to these foods run the risk of serious or life-threatening allergic reaction if they consume these products

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Inflammation and Trajectory of Renal Function in Community-Dwelling Older Adults - American Geriatric Society

Objectives

To examine the hypothesis that the inflammatory state of aging is a risk factor for accelerated renal function (RF) decline using inflammatory biomarkers and RF measures collected over 9 years of follow-up in relatively healthy individuals enrolled in the Invecchiare in Chianti study.

Design

Longitudinal.

Setting

Community.

Participants

Individuals aged 60 and older with baseline estimated glomerular filtration rate (eGFR) of 60 mL/min per 1.73 m² and greater and no diabetes mellitus (DM) (N = 687).

Measures

eGFR, as a proxy for RF, was determined using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at baseline and 3-, 6-, and 9-year follow-up. Incident chronic kidney disease (CKD) was defined as new-onset eGFR less than 60 mL/min per 1.73 m² at each follow-up. Predictors included baseline and time-dependent inflammatory biomarkers: soluble tumor necrosis factor alpha receptors (sTNFα-R1 and -R2), interleukin (IL)-6, IL-18, IL-1β, IL-1 receptor antagonist, and high-sensitivity C-reactive protein.

Results

Higher baseline sTNFα-R1 was significantly associated with lower eGFR over 9 years, independent of DM or blood pressure (baseline: = −0.39, P = .001; 3-year: = −0.26, P = .001; 6-year: = −0.36, P = .001; 9-year: = −0.47, P = .001). The rate of TNFα-R1 change was significantly associated with rate of eGFR change ( = −0.18, P = .001). Baseline sTNFα-R1 predicted incident CKD (per 1-standard deviation increment: 3-year: relative risk (RR) = 1.3, 95% confidence interval (CI) = 1.1–1.5; 6-year: RR = 1.5, 95% CI = 1.1–2.2; 9-year RR = 1.6, 95% CI = 1.1–2.2). Similar results were found for sTNFα-R2.

Conclusion

Baseline TNFα-R levels and their rates of change were significantly associated with RF decline and incident CKD in older adults independent of DM or blood pressure.

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Effects of Survey Mode on Consumer Assessment of Healthcare Providers and Systems (CAHPS) Hospice Survey Scores - American Geriatric Society

Objectives

To examine the effect of mode of survey administration on response rates and response tendencies for the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Hospice Survey and develop appropriate adjustments.

Design

Survey response data were obtained after sampling and fielding of the CAHPS Hospice Survey in 2015. Sampled caregivers and decedents were randomized to one of three modes: mail only, telephone only, and mixed mode (mail with telephone follow-up). Linear regression analysis was used to examine the effect of mode on individual responses to questions (6 composite measures and 2 global measures that examine hospice quality).

Setting

U.S. hospice programs (N = 57).

Participants

Primary caregivers of individuals who died in hospice (N = 7,349).

Measurements

Outcomes were 8 hospice quality measures (6 composite measures, 2 global measures). Analyses were adjusted for differences in case-mix (e.g., decedent age, payer for hospice care, primary diagnosis, length of final episode of hospice care, respondent age, respondent education, relationship of decedent to caregiver, survey language, and language spoken at home) between hospices.

Results

Response rates were 42.6% for those randomized to mail only, 37.9%, for those randomized to telephone only, and 52.6% for those randomized to mixed mode (P < .001 for difference). There were significant mode effects (P < .05) for 10 of the 24 questions that compose the quality measures, with mail-only respondents being significantly more likely to report better experiences than telephone-only respondents.

Conclusion

Unlike results observed in previous mode experiments for hospital CAHPS, hospice primary caregivers tend to respond more negatively by telephone than by mail. Valid comparisons of hospice performance require that reported hospice scores be adjusted for survey mode.

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Asenjonamides A–C, antibacterial metabolites isolated from Streptomyces asenjonii strain KNN 42.f from an extreme-hyper arid Atacama Desert soil - Journal of Antibiotics

Asenjonamides A–C, antibacterial metabolites isolated from Streptomyces asenjonii strain KNN 42.f from an extreme-hyper arid Atacama Desert soil

Asenjonamides A–C, antibacterial metabolites isolated from <i>Streptomyces asenjonii</i> strain KNN 42.f from an extreme-hyper arid Atacama Desert soil, Published online: 23 January 2018; doi:10.1038/s41429-017-0012-0

Asenjonamides A–C, antibacterial metabolites isolated from Streptomyces asenjonii strain KNN 42.f from an extreme-hyper arid Atacama Desert soil

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Sun Noodle - New Jersey - Issues Allergy Alert on Undeclared Fish in Tonkotsu Ramen - FDA Safety Alerts & Drug Recalls

Sun Noodle of Carlstadt, NJ is voluntarily recalling one lot of their retail Tonkotsu Ramen because it is mis-labeled. While it is labeled Tonkotsu, the actual flavor packet inside is Assari Shoyu, which contains an additional undeclared allergen of fish (sardines).

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Productos Pacheco Inc Emite La Alerta De Alergenos No Declarados: Trigo, Soya, Huevo, Leche Y Colorantes No Declarados En Sus Productos De Panaderia - FDA Safety Alerts & Drug Recalls

PRODUCTOS PACHECO INC. en Bayamón, Puerto Rico, está recogiendo los siguientes productos marca PACHECO porque pueden contener alérgenos no declarados: Trigo, Soya, Huevo, Leche y colorantes artificiales no listados en ingredientes Rojo#40, Amarillo#5, Amarillo#6. Las personas que tienen alergias a estos alimentos y colores artificiales corren el riesgo de una reacción alérgica grave o que pone en peligro la vida si consumen estos productos.

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Magno-Humphries Laboratories, Inc., Issues Voluntary Nationwide Recall of Basic Drugs Brand of Senna Laxative Due to Mislabeling - FDA Safety Alerts & Drug Recalls

Tigard, OR, Magno-Humphries Laboratories, Inc., is voluntarily recalling one lot of Basic Drugs Brand of Senna Laxative tablets, 8.6mg Sennosides to the consumer level due to a customer complaint that their bottle labeled as Senna Laxative actually contained Basic Drugs Brand of Naproxen Sodium 220mg. Naproxen Sodium 220mg tablet is used as a pain reliever and is a nonsteroidal anti-inflammatory drug (NSAID).

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Flawless Beauty, LLC Issues Voluntary Recall of Unapproved Drugs - FDA Safety Alerts & Drug Recalls

Ocean Township, NJ. In accordance with a Consent Decree of Permanent Injunction ordered in the United States District Court for the District of New Jersey, Flawless Beauty, LLC is voluntarily recalling all lots of nineteen different products sold individually or as part of multi-unit kits alleged by the U.S. Food and Drug Administration ("FDA") to be misbranded or unapproved new drugs pursuant to the Federal Food, Drug, and Cosmetic Act. The FDA believes that these drugs present serious public health risks.

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Where Are Antipsychotics Prescribed in Nursing Homes Initiated? - American Geriatric Society

Objectives

To describe the settings of care in which antipsychotics that nursing home (NH) residents received were likely to have been initiated.

Design

Cross-sectional.

Setting

Iowa NHs.

Participants

Fee-for-service Medicare beneficiaries who had NH stays between January 1, 2011, and December 31, 2014, and had new use of antipsychotics during their NH stays, defined as no antipsychotic use in NHs in the last 6 months.

Measurements

A linked dataset of Chronic Condition Data Warehouse Medicare claims and Long-Term Care Minimum Data Set (MDS) 3.0 was used to determine care settings of antipsychotic initiations.

Results

Of 7,496 residents with new antipsychotic use in NHs, 4,794 (64.0%, 95% confidence interval (CI) = 62.9–65.0%) initiated them in NHs, 1,392 (18.6%, 95% CI = 17.7–19.5%) appeared to have had them initiated in hospitals, and 1,310 (17.5%, 95% CI = 16.6–18.3%) had antipsychotics first dispensed as outpatients. Antipsychotics were commonly prescribed during the early NH stays, and 3,026 (40.4%, 95% CI = 39.3–41.5%) of the entire sample received antipsychotic therapy within the first 7 days after NH admissions. Fifty-eight percent (n = 4,348) of the study residents initiating antipsychotics had potentially appropriate antipsychotic indications according to MDS records.

Conclusion

Most residents initiated antipsychotic therapy in NHs, confirming that NH providers are appropriate primary target of interventions to reduce antipsychotic initiation in their residents. However, many antipsychotics were continued from other settings, indicating a need to evaluate the necessity of continued antipsychotic treatment after such transitions of care.

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Reducing Off-Label Antipsychotic Use in Older Adults: Time to Look Beyond the Doors of Nursing Homes - American Geriatric Society

This editorial comments on the article by Zhang et al.

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Break Ventures/California Basics Recalls "Zero For Him" 150ct Lot#1710-638 Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Break Ventures/California Basics is recalling its Dietary Supplement "Zero for Him 150ct" Lot#1710-638(the "Product") because it may 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

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Arthri-D, LLC Recalls Arthri-D Lot#1701-092 Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Arthri-D, LLC is recalling its Dietary Supplement "Arthri-D 120ct" Lot#1701-092 (the "Product") because it may 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

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JustFoodForDogs Voluntarily Recalls Three Daily Diets because of Possible Listeria monocytogenes Health Risk from Green Beans - FDA Safety Alerts & Drug Recalls

JustFoodForDogs (JFFD) of Los Alamitos, CA, is voluntarily recalling its Beef & Russet Potato, Fish & Sweet Potato and Turducken dog food meals in all sizes. JFFD uses 100% USDA and other restaurant grade ingredients in all of its pet food, and because the green beans used in these meals may be contaminated with Listeria monocytogenes, the company is alerting the public.

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Ottogi America, Inc. Issues Allergy Alert on Undeclared Milk in Rice Cake Soup - FDA Safety Alerts & Drug Recalls

Ottogi America, Inc. of Gardena, CA is recalling 6.40 ounce “Rice cake soup” food, because it may contain undeclared milk. People who have allergies to milk 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 new policy steps for strengthening public warning and notification of recalls - FDA Press Releases

FDA discusses new policy steps for strengthening public warning and notification of recalls

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Effects of Cognitive Training on Cognition and Quality of Life of Older Persons with Dementia - American Geriatric Society

Objectives

To evaluate the effect of cognitive training on cognition and health-related quality of life (HRQoL) in community-dwelling persons with dementia.

Design

Single-blind randomized controlled trial with 3- and 9-month follow-up.

Setting

Adult day care centers in Helsinki, Finland.

Participants

Older individuals with mild to moderate dementia living at home and attending adult day care twice a week (N = 147; mean age 83, 72% female, 63% at mild stage of dementia).

Intervention

A systematic 12-week training program focused on subskills of executive function: attention, working memory, cognitive flexibility, and planning. The intervention group (n = 76) underwent cognitive training twice a week for 45 minutes, and the control group (n = 71) attended day care as usual.

Measurements

Primary outcomes were the Alzheimer's Disease Assessment Scale—Cognitive subscale (ADAS-Cog) for global cognition and the 15-dimensional instrument (15D) for HRQoL. The outcomes were measured at baseline and 3 and 9 months.

Results

Both groups deteriorated in global cognition and HRQoL during follow-up, and there were no differences between the two groups in change on the ADAS-Cog (P = .43) or 15D (P = .61) over time (adjusted for age and sex). At 3 months, changes were 0.8 (95% confidence interval (CI) = −0.2–1.8) for the intervention group and 1.7 (95% CI = 0.6–2.7) for the control group on the ADAS-Cog and −0.040 (95% CI = −0.058 to −0.021) for the intervention group and −0.037 (95% CI = −0.056 to −0.018) for the control group on the 15D.

Conclusion

Systematic cognitive training had no effect on global cognition or HRQoL in community-living persons with mild to moderate dementia.

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Cognitive Training for Older Adults: What Works? - American Geriatric Society

This editorial comments on the article by Kallio et al.

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Clinical Intentions of Antibiotics Prescribed Upon Discharge to Hospice Care - American Geriatric Society

Objectives

To better understand the clinical intentions for antibiotic prescribing upon discharge from acute care to hospice care.

Design

Retrospective cohort study.

Setting

Five hundred forty-four–bed academic, acute-care, tertiary referral hospital in Portland, Oregon.

Participants

Adults (≥18) who received an outpatient prescription for antibiotics on discharge from an acute care hospital to hospice care between January 1, 2009 and December 31, 2011 (N = 149).

Measurements

We determined whether antibiotics were indicated for treatment of an active infection, palliative treatment, prophylaxis, or prescribed according to family or participant preference.

Results

Antibiotics were prescribed to 17.6% (n = 149) of individuals discharged to hospice care over the 3-year study period. Antibiotics were most frequently prescribed for pneumonia (19.5%), urinary tract infections (18.9%), and gastrointestinal tract infections (17.0%). The explicit rationale for antibiotic prescription was documented for only 72 prescriptions (45.3%). For 84 (52.8%) participants, antibiotics were used to treat an active infection in the hospital. Of prescriptions with a documented rationale, 37.5% indicated that the intent was curative, 26.4% prophylaxis, and 22.2% to suppress an infection. For 19.4% of prescriptions, participants or their family members specifically wanted to be treated with antibiotics. Only 9.7% of prescriptions specifically indicated that antibiotics were prescribed for palliative reasons.

Conclusion

Antibiotics were frequently prescribed for treatment of active infection in individuals discharged to hospice care. Further research is needed to document antibiotic benefits and risks and optimize medication management at the end of life.

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Mobility Trajectories at the End of Life: Comparing Clinical Condition and Latent Class Approaches - American Geriatric Society

Objectives

To assess mobility disability trajectories before death in a large sample of very old adults using two analytical approaches to determine how well they corresponded.

Design

Decedent sample from the Health, Aging and Body Composition (Health ABC) Study. Data were collected between 1997 and 2015.

Setting

Pittsburgh, Pennsylvania, and Memphis, Tennessee.

Participants

Individuals randomly selected from well-functioning white Medicare beneficiaries and all black community residents meeting age criteria (70–79) (N = 3,075).

Measurements

Participants were interviewed in person or by phone at least every six months throughout the study. Of the 1,991 participants who died by the end of the study, 1,410 had been interviewed for 3 years before death, including an interview 6 months before dying. We analyzed self-reported mobility collected prospectively at 6-month intervals during the last 3 years of life. We derived trajectories in two ways: by averaging decline within decedent groups prespecified according to clinical conditions and by estimating trajectory models using maximum-likelihood semiparametric modeling.

Results

Ninety-eight percent of decedents were classified according to 4 prespecified clinical conditions (sudden death, terminal, organ failure, frailty), which produced groups with different characteristics. Five disability trajectories were identified: late decline, progressive disability, moderate disability, early decline, and persistent disability. Disability trajectory and clinical condition grouping confirmed previous research but were only marginally related.

Conclusion

Derived disability trajectories and grouping according to clinical condition provide useful information about different facets of the end-of-life experience. The lack of fit between them suggests a need for greater attention to heterogeneity in disability in the period before death.

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Near Visual Impairment Incidence in Relation to Diabetes in Older People: The Three-Cities Study - American Geriatric Society

Objectives

To characterize the relationship between diabetes mellitus (DM) and future risk of near vision impairment (VI) in a community-dwelling population of older people.

Design

Seven-year population-based longitudinal study.

Setting

Three-Cities Study, a French prospective study designed to assess the risk of cognitive and functional decline attributable to vascular factors.

Participants

Community-dwelling individuals aged 65 and older (N = 8,412).

Measurements

DM was determined at baseline according to self-reported DM, antidiabetic treatment, and fasting blood glucose. Near visual acuity was measured at baseline and 2, 4, and 7 years later. Near VI was defined as a Snellen score greater than 20/30.

Results

DM was associated with a higher risk of near VI in an adjusted model (hazard ratio (HR) = 1.24, 95% confidence interval (CI) = 1.02–1.52, P = .03). Because of an interaction between Body Mass Index (BMI) and diagnosed DM, the longitudinal analyses were stratified according to BMI category. DM was associated with greater risk of near VI only in underweight (BMI <21.0 kg/m², HR = 2.89, 95% CI = 1.18–7.03) and normal-weight (BMI 21.0–24.9 kg/m², HR = 1.60, 95% CI = 1.10–2.32), but not overweight (P = .69) and obese (P = .09) subjects.

Conclusion

DM is a risk factor for near VI in older people, particularly in those with a low or normal BMI. This risk profile should be taken into account in older adults to support their independence.

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Geriatric Syndromes, Dementia Subtypes, Gizmo Idolatry - American Geriatric Society

See the response from Teng et al.

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Response to Dr. Finucane - American Geriatric Society

This is a response to the article by Thomas E. Finucane.

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Response to Teng et al. - American Geriatric Society

This is a response to the article by Teng et al.

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Accurate Etiological Diagnosis of Dementia Contributes to Better Clinical Care - American Geriatric Society

See the response from Finucane et al.

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Allergy Alert Issued in Select North Atlantic Whole Foods Market Stores for Undeclared Almond Flour in Cheesecake Bars - FDA Safety Alerts & Drug Recalls

CAMBRIDGE, Massachusetts (January 15, 2018) – Nine Whole Foods Market stores in Connecticut, Massachusetts, and Rhode Island are voluntarily recalling cheesecake bars because the product potentially contained a tree nut allergen (almond flour) that was not listed on the product label. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reactions if they consume these products

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Isopentylated diphenyl ether derivatives from the fermentation products of an endophytic fungus Phomopsis fukushii - Journal of Antibiotics

Isopentylated diphenyl ether derivatives from the fermentation products of an endophytic fungus Phomopsis fukushii

Isopentylated diphenyl ether derivatives from the fermentation products of an endophytic fungus <i>Phomopsis fukushii</i>, Published online: 18 January 2018; doi:10.1038/s41429-017-0006-y

Isopentylated diphenyl ether derivatives from the fermentation products of an endophytic fungus Phomopsis fukushii

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The human muscarinic acetylcholine receptor antagonist, Dicyclomine targets signal transduction genes and inhibits the virulence factors in the human pathogen, Candida albicans - Journal of Antibiotics

The human muscarinic acetylcholine receptor antagonist, Dicyclomine targets signal transduction genes and inhibits the virulence factors in the human pathogen, Candida albicans

The human muscarinic acetylcholine receptor antagonist, Dicyclomine targets signal transduction genes and inhibits the virulence factors in the human pathogen, <i>Candida albicans</i>, Published online: 18 January 2018; doi:10.1038/s41429-017-0013-z

The human muscarinic acetylcholine receptor antagonist, Dicyclomine targets signal transduction genes and inhibits the virulence factors in the human pathogen, Candida albicans

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Two new lankacidin-related metabolites from Streptomyces sp. HS-NF-1178 - Journal of Antibiotics

Two new lankacidin-related metabolites from Streptomyces sp. HS-NF-1178

Two new lankacidin-related metabolites from <i>Streptomyces</i> sp. HS-NF-1178, Published online: 18 January 2018; doi:10.1038/s41429-017-0004-0

Two new lankacidin-related metabolites from Streptomyces sp. HS-NF-1178

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Prodigiosin R2, a new prodigiosin from the roseophilin producer Streptomyces griseoviridis 2464-S5 - Journal of Antibiotics

Prodigiosin R2, a new prodigiosin from the roseophilin producer Streptomyces griseoviridis 2464-S5

Prodigiosin R2, a new prodigiosin from the roseophilin producer <i>Streptomyces griseoviridis</i> 2464-S5, Published online: 18 January 2018; doi:10.1038/s41429-017-0011-1

Prodigiosin R2, a new prodigiosin from the roseophilin producer Streptomyces griseoviridis 2464-S5

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In vitro and in vivo antimicrobial activity of TS2037, a novel aminoglycoside antibiotic - Journal of Antibiotics

In vitro and in vivo antimicrobial activity of TS2037, a novel aminoglycoside antibiotic

In vitro and in vivo antimicrobial activity of TS2037, a novel aminoglycoside antibiotic, Published online: 18 January 2018; doi:10.1038/s41429-017-0002-2

In vitro and in vivo antimicrobial activity of TS2037, a novel aminoglycoside antibiotic

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Cordybislactone, a stereoisomer of the 14-membered bislactone clonostachydiol, from the hopper pathogenic fungus Cordyceps sp. BCC 49294: revision of the absolute configuration of clonostachydiol - Journal of Antibiotics

Cordybislactone, a stereoisomer of the 14-membered bislactone clonostachydiol, from the hopper pathogenic fungus Cordyceps sp. BCC 49294: revision of the absolute configuration of clonostachydiol

Cordybislactone, a stereoisomer of the 14-membered bislactone clonostachydiol, from the hopper pathogenic fungus <i>Cordyceps</i> sp. BCC 49294: revision of the absolute configuration of clonostachydiol, Published online: 18 January 2018; doi:10.1038/s41429-017-0008-9

Cordybislactone, a stereoisomer of the 14-membered bislactone clonostachydiol, from the hopper pathogenic fungus Cordyceps sp. BCC 49294: revision of the absolute configuration of clonostachydiol

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Agrocin 108 is a 5'-cytidine nucleotide bacteriocin containing a carbocyclic phosphoryl-ascorbate group - Journal of Antibiotics

Agrocin 108 is a 5'-cytidine nucleotide bacteriocin containing a carbocyclic phosphoryl-ascorbate group

Agrocin 108 is a 5'-cytidine nucleotide bacteriocin containing a carbocyclic phosphoryl-ascorbate group, Published online: 18 January 2018; doi:10.1038/s41429-017-0014-y

Agrocin 108 is a 5'-cytidine nucleotide bacteriocin containing a carbocyclic phosphoryl-ascorbate group

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Linearmycins are lytic membrane-targeting antibiotics - Journal of Antibiotics

Linearmycins are lytic membrane-targeting antibiotics

Linearmycins are lytic membrane-targeting antibiotics, Published online: 18 January 2018; doi:10.1038/s41429-017-0005-z

Linearmycins are lytic membrane-targeting antibiotics

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Palmer Candy Company Announces Voluntary Recall of Sea Salt Caramel Hearts - FDA Safety Alerts & Drug Recalls

Palmer Candy Company (www.palmercandy.com), announced today a limited recall of Sea Salt Caramel Hearts that were only sold at Bomgaards Supply Inc. Store in the Midwest States. The voluntary recall, in cooperation with the U.S. Food and Drug Administration (FDA) due to abundance of caution of a possible peanut allergen contamination. 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.

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AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Levofloxacin in 5% Dextrose 250mg/50mL Due to Presence of Visible Particulate Matter Tentatively Identified as Mold - FDA Safety Alerts & Drug Recalls

FOR IMMEDIATE RELEASE – 01-12-2018 – East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling one lot of Levofloxacin in 5% Dextrose Injection 250mg/50mL in a Single-Use flexible container NDC 55150-243-46, Lot CLF160003, Expiry date May 2018, to the hospital level. The product has been found to contain visible particulate matter tentatively identified as mold. This problem was discovered as a result of a product complaint in which the contents of one flexible bag was found to contain white particulate matter

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Underdiagnosis of influenza virus infection in hospitalized older adults - American Geriatric Society

Abstract

Objective: To describe factors associated with provider-ordered influenza testing among hospitalized adults.

Design: Information on patient demographics, symptoms, and provider-ordered influenza testing were collected by questionnaire and chart review. We conducted prospective laboratory-based surveillance using reverse-transcriptase polymerase chain reaction (RT-PCR), the gold-standard for diagnosis of influenza, to determine how patient characteristics and provider-ordered testing impacted accurate influenza diagnosis.

Setting: One academic and three community hospitals in Davidson County, Tennessee, USA.

Participants: 1422 adults ages 18 years and older with acute respiratory illness or non-localizing fever.

Measurements: We compared characteristics of participants with and without provider-ordered testing for influenza using the Wilcoxon test and Pearson's chi-square test. Multivariable logistic regression models identified factors predictive of provider-ordered influenza testing.

Results: Overall 28% (399/1422) of participants had provider-ordered influenza testing. Patients who were tested were younger than those not tested (58 ± 18 years vs. 66 ± 15 years, p < 0.001) and more likely to have influenza-like illness (ILI, 71% vs. 49%, p < 0.001). ILI increased with decreasing age: 48% ≥ 65 years; 60% 50-64 years; and 63% 18-49 years. Among all patients, presence of ILI and younger age were independent predictors of provider-ordered testing. Among the 136 patients with RT-PCR confirmed influenza, ILI was the only significant predictor of provider-ordered testing (AOR 3.43, 95% CI 1.22-9.70).

Conclusion: Adults 65 years and older hospitalized with fever or respiratory symptoms during influenza season are less likely to have a provider-ordered influenza test than younger adults. Some, but not all, of this disparity is due to a lower likelihood of ILI presentation. Further strategies are needed to increase clinician awareness and testing in this vulnerable group. This article is protected by copyright. All rights reserved.

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Baxter Expands Voluntary Nationwide Recall to Include Second Lot of Nexterone Injection Due to Presence of Particulate Matter - FDA Safety Alerts & Drug Recalls

Following the issuance of a voluntary recall dated November 10, 2017 of one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection, Baxter International Inc. announced today it is expanding the recall to include a second lot (NC109123) of NEXTERONE due to the potential presence of particulate matter.

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Bellisio Foods, Inc. Issues Allergy Alert Regarding Certain Michelina’s Fettuccine Alfredo Packages Due to Potential Presence of Undeclared Soy - FDA Safety Alerts & Drug Recalls

Bellisio Foods, Inc., a Jackson, Ohio, manufacturer, is voluntarily recalling certain Michelina’s Fettuccine Alfredo due to the possibility some packages may contain undeclared chicken with soy that is not listed on packaging. People who have an allergy or sensitivity to soy may run the risk of serious allergic reaction(s) if they consume this product.

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Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review - FDA Press Releases

Statement from FDA Commissioner Scott Gottlieb, M.D., in response to GAO report regarding FDA’s ongoing commitment to employing a least burdensome approach to device review

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Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA’s ongoing efforts to increase access to complex generic drugs - FDA Press Releases

GAO issued the report “Generic Drugs: FDA Should Make Public Its Plans to Issue and Revise Guidance on Nonbiological Complex Drugs,” which contains a single recommendation for the FDA -- that the agency publicly announce its plans to issue or revise guidance for these drug products. The FDA agrees and is actively working to accomplish this goal.

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FDA Commissioner Scott Gottlieb, M.D., updates on some ongoing shortages related to IV fluids - FDA Press Releases

FDA updates on some ongoing shortages related to IV fluids

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FDA and DoD launch program to expedite availability of medical products for the emergency care of American military personnel - FDA Press Releases

The U.S. Food and Drug Administration and the Department of Defense launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.

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FDA Commissioner Scott Gottlieb, M.D., on new steps FDA is taking to enhance transparency of clinical trial information to support innovation and scientific inquiry related to new drugs - FDA Press Releases

FDA takes steps to enhance transparency of clinical trial data used in support of new drug approvals

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Facility and State Variation in Hip Fracture in U.S. Nursing Home Residents - American Geriatric Society

Objectives

To quantify the variation in hip fracture incidence across U.S. nursing home (NH) facilities and states and examine how hip fracture incidence varies according to facility- and state-level characteristics.

Design

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

Setting

U.S. NHs with 100 or more beds.

Participants

Long-stay NH residents between May 1, 2007, and April 30, 2008, from 1,481 facilities and 46 U.S. states (N = 201,892).

Measurements

Incident hip fractures were ascertained using Medicare Part A diagnostic codes. Each resident was followed for up to 2 years.

Results

The mean adjusted incidence rate of hip fractures for all facilities was 3.13 (95% confidence interval (CI) = 3.01–3.26) per 100 person-years (range 1.20, 95% CI = 1.15–1.26 to 6.40, 95% CI = 6.07–6.77). Facilities with the highest rates of hip fracture had greater percentages of residents taking psychoactive medications (top tertile 27.2%, bottom tertile 24.8%), and fewer nursing (top tertile 3.43, bottom tertile 3.53) and direct care (top tertile 3.22, bottom tertile 3.29) hours per day per resident. The combination of state and facility characteristics explained 6.7% of the variation in hip fracture, and resident characteristics explained 7.6%.

Conclusion

Much of the variation in hip fracture incidence remained unexplained, although these findings indicate that potentially modifiable state and facility characteristics such as psychoactive drug prescribing and minimum staffing requirements could be addressed to help reduce the rate of hip fracture in U.S. NHs.

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Preoperative Cognitive Impairment As a Predictor of Postoperative Outcomes in a Collaborative Care Model - American Geriatric Society

Objectives

To compare postoperative outcomes of individuals with and without cognitive impairment enrolled in the Perioperative Optimization of Senior Health (POSH) program at Duke University, a comanagement model involving surgery, anesthesia, and geriatrics.

Design

Retrospective analysis of individuals enrolled in a quality improvement program.

Setting

Tertiary academic center.

Participants

Older adults undergoing surgery and referred to POSH (N = 157).

Measurements

Cognitive impairment was defined as a score less than 25 out of 30 (adjusted for education) on the St. Louis University Mental Status (SLUMS) Examination. Median length of stay (LOS), mean number of postoperative complications, rates of postoperative delirium (POD, %), 30-day readmissions (%), and discharge to home (%) were compared using bivariate analysis.

Results

Seventy percent of participants met criteria for cognitive impairment (mean SLUMS score 20.3 for those with cognitive impairment and 27.7 for those without). Participants with and without cognitive impairment did not significantly differ in demographic characteristics, number of medications (including anticholinergics and benzodiazepines), or burden of comorbidities. Participants with and without cognitive impairment had similar LOS (P = .99), cumulative number of complications (P = .70), and 30-day readmission (P = .20). POD was more common in those with cognitive impairment (31% vs 24%), but the difference was not significant (P = .34). Participants without cognitive impairment had higher rates of discharge to home (80.4% vs 65.1%, P = .05).

Conclusion

Older adults with and without cognitive impairment referred to the POSH program fared similarly on most postoperative outcomes. Individuals with cognitive impairment may benefit from perioperative geriatric comanagement. Questions remain regarding the validity of available measures of cognition in the preoperative period.

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Hiland Dairy Announces Voluntary Recall Of Hiland Dairy Orange Juice And Tampico Citrus Punch - FDA Safety Alerts & Drug Recalls

Hiland Dairy is announcing a voluntary recall of two products produced at the Omaha, Nebraska facility, over concerns the products may contain milk protein that could affect those individuals that have sensitivity to milk allergens. 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. No illnesses or allergic reactions have been reported at this time.

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Rico Brand Issues Allergy Alert on Undeclared Soy in Tofu Breakfast Burrito - FDA Safety Alerts & Drug Recalls

Rico Brand of Salt Lake City, Utah is recalling Tofu Breakfast Burrito, because it may contain undeclared Soy. People who have an allergy or severe sensitivity to Soy 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 FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products - FDA Press Releases

: FDA decision to seek additional time to reassess rule that would have changed longstanding practices for how the agency determined the ‛intended use’ of medical products

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FDA approves first treatment for breast cancer with a certain inherited genetic mutation - FDA Press Releases

FDA approves first treatment for breast cancer with a certain inherited genetic mutation

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Hom/Ade Foods, Inc. Voluntarily Recalls Frozen Biscuits Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Hom/Ade Foods, Inc is voluntarily recalling Mary B’s® brand biscuits due to potential contamination with Listeria monocytogenes. The problem was discovered in a product sampling conducted by an outside co-packer, who manufactured the product.

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Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls

January 10, 2018 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily expanding the recall issued on December 27, 2017 to include the below lots of sterile drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening.

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Gilster - Mary Lee Corp. Issues a Recall For Undeclared Milk Allergen in Essential Everyday® Chicken Coating - FDA Safety Alerts & Drug Recalls

January 8, 2018 - Gilster-Mary Lee, 520 Old St. Mary’s Road, of Perryville, Missouri, is voluntarily recalling one lot of Essential Everyday® Coat & Bake Original Chicken coating, UPC 41303-01572 at the consumer level because it may contain 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 these products.

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FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues - FDA Press Releases

FDA warns Becton Dickinson & Company of significant violations of the law as part of ongoing investigation into lead testing issues

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FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use - FDA Press Releases

The U.S. Food and Drug Administration announced today that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.

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No Expiration Date on the Association Between Physical Activity and Mortality - American Geriatric Society

This editorial comments on the article by LaMonte et al.

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Competing Risks of Fracture and Death in Older Adults with Chronic Kidney Disease - American Geriatric Society

Objectives

To examine whether chronic kidney disease (CKD) at any stage is associated with fracture risk after adjusting for competing mortality and to determine whether age or race modify the relationship between CKD and fracture risk.

Design

Prospective cohort study.

Setting

Department of Veterans Affairs (VA) national healthcare system.

Participants

Men receiving VA primary care aged 65 and older with no history of fracture or osteoporosis therapy (N = 712, 918).

Measurements

We determined CKD stage from baseline estimated glomerular filtration rate (eGFR). Participants were followed for up to 10 years for occurrence of any fracture or death. We ascertained fractures and covariates from VA medical records and Medicare claims.

Results

Of the 356,459 older veterans with CKD (defined as eGFR <60 mL/min per 1.73 m²), 15.7% (n = 56,032) experienced a fracture, and 43.0% (n = 153,438) died over a median time at risk of 5.2 years. Veterans with CKD Stages 3 to 5 had a greater risk of death than those without CKD, which biased estimates from traditional survival models. Competing risk models showed that Stage 3 CKD was associated with greater hazard (adjusted subdistribution hazard ratio (sdHR) = 1.07, 95% confidence interval (CI) = 1.02–1.11) of fracture (than those without CKD) and a trend toward greater hazard for Stage 4 (sdHR = 1.07, 95% CI = 0.94–1.22) and Stage 5 (sdHR = 1.31, 95% CI = 0.97–1.77) CKD. Age, race, and bone mineral density did not modify the relationship between CKD and fracture risk.

Conclusions

In older male veterans, CKD, including Stage 3, is associated with a moderately greater fracture risk irrespective of age, race, or bone mineral density.

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The Benefits of Reviewing - American Geriatric Society

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Association Between Sensory Impairment and Dementia in Older Adults: Evidence from China - American Geriatric Society

Objectives

To determine the association between sensory impairment and dementia in Chinese older adults.

Design

Cross-sectional.

Setting

Older adults in 31 provinces of China.

Participants

Individuals aged 65 and older (N = 250,752).

Measurements

Psychiatrists ascertained dementia based on the International Classification of Diseases, 10th Revision. Sensory impairment was measured as only hearing impairment, only vision impairment, and combined sensory impairment (combined hearing and vision impairment). Hearing impairment was defined as greater than 40 dB loss in the better ear according to the standard of the World Health Organization (WHO) Prevention of Deafness and Hearing Impairment (PDH) standard 97.3. Ophthalmologists assessed vision impairment according to the WHO best-corrected visual acuity (BCVA) criteria (low vision: 0.05≤BCVA ≤0.29; blindness: no light perception ≤ BCVA <0.05, visual field less than 10 degrees; the better-seeing eye).

Results

The prevalence of dementia was 0.41% (95% CI = 0.39–0.44%) without sensory impairment, 0.83% (95% CI = 0.70–0.99%) with only visual impairment, 0.61 (95% CI = 0.53–0.71%) with only hearing impairment, and 1.27% (95% CI = 1.00–1.61%) with combined sensory impairments. After adjusting for sociodemographic characteristics, vision impairment (odds ratio (OR) = 1.58, 95% CI = 1.28–1.96) and combined sensory impairments (OR = 1.64, 95% CI = 1.23–2.20) were associated with greater risk of severe to extremely severe dementia. Hearing impairment was not significantly associated with dementia.

Conclusion

Sensory impairments are associated with greater risk of dementia in Chinese older adults. Studies are needed to further explore the pathway of this association in Chinese elderly adults and to provide suggestions to improve health status for this population.

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International Laboratories, LLC Issues Voluntary Nationwide Recall of one (1) Lot of Clopidogrel Tablets USP, 75 mg packaged in bottles of 30 tablets Due to Mislabeling NDC # 54458-888-16; Lot # 117099A - FDA Safety Alerts & Drug Recalls

International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.

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Wells Collection Inc Issues Alert On Undeclared Sulfites In Rely Brand Dried Longya Lily - FDA Safety Alerts & Drug Recalls

Wells Collection Inc of Brooklyn, NY, is recalling its 8 ounce packages of Rely Brand Dried Longya Lily because the product contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

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Fieldbrook Foods Corporation, Announces an Extension of Voluntary Recall of Orange Cream Bars and Chocolate Coated Vanilla Ice Cream Bars for Possible Health Risk - FDA Safety Alerts & Drug Recalls

Fieldbrook Foods Corporation has issued a voluntary recall of all orange cream bars and chocolate coated vanilla ice cream bars that were produced in 2017 on the company’s Hoyer 1 Line at its Dunkirk, NY plant (plant code 362677). This is the only production line and the only Fieldbrook Foods plant (of 3) involved in this recall notice. Both products are being recalled due to the possibility that they may be contaminated 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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Dollar General Announces Voluntary Recall of Clover Valley® Iced Oatmeal Cookies Over Undeclared Milk and Tree Nuts - FDA Safety Alerts & Drug Recalls

Dollar General Corporation announced a voluntary recall of its 12-ounce packages of Clover Valley® Iced Oatmeal Cookies with lot # L46217 30 with a best-by date of August 18, 2018 over concerns of undeclared milk and tree nuts. Consumers with a milk and/or nut allergy or sensitivity to these items should not consume these products due to a possible health risk or serious allergic reaction. No illnesses or reactions have been reported at this time.

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Fieldbrook Foods Corporation, Announces a Voluntary Recall of Orange Cream Bars for Possible Health Risk - FDA Safety Alerts & Drug Recalls

Fieldbrook Foods Corporation of Dunkirk NY has issued a voluntary recall of 20 cases of the Tops brand of Orange Cream Bars and 320 cases of the Meijer Purple Cow brand Orange Cream Bars due to the possibility that the product may be contaminated 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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Hong Lee Trading Inc. Issues Allergen Alert on Undeclared Milk Allergens in Chao Café Vietnamese Instant Coffee Mixed 3 in 1 - FDA Safety Alerts & Drug Recalls

Hong Lee Trading Inc., NY, is recalling its CHAO CAFÉ VIETNAMESE INSTANT COFFEE MIXED 3 IN 1, 384 GRAM, CONTAINER CODE JUNE 06 2018, 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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Preface: special issue Hamao Umezawa (1914–1986) - Journal of Antibiotics

Preface: special issue Hamao Umezawa (1914–1986)

Preface: special issue Hamao Umezawa (1914–1986), Published online: 05 January 2018; doi:10.1038/ja.2017.136

Preface: special issue Hamao Umezawa (1914–1986)

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Memory of Professor Hamao Umezawa - Journal of Antibiotics

Memory of Professor Hamao Umezawa

Memory of Professor Hamao Umezawa, Published online: 05 January 2018; doi:10.1038/ja.2017.137

Memory of Professor Hamao Umezawa

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Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages - FDA Press Releases

Statement by FDA Commissioner Scott Gottlieb, M.D., update on recovery efforts in Puerto Rico, and continued efforts to mitigate IV saline and amino acid drug shortages

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Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance - FDA Press Releases

FDA announced today guidance outlining four key areas that it does not intend to enforce in the FDA Food Safety Modernization Act rules. The provisions relate to the “farm” definition, requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances, and requirements related to certain human food by-products for use as animal food.

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FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product, Atcell - FDA Press Releases

FDA warns American CryoStem Corporation of significant deviations related to its unapproved stem cell product

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Condies Foods Issues Allergy Alert on Undeclared Milk and Egg allergen in Veggie Cup Item# 40781 - FDA Safety Alerts & Drug Recalls

Condies Foods of Kearns, UT is recalling 166 cases of code date “USE THRU 01/05/2018,” there is a possibility that this may contain undeclared milk and egg allergens. People who have an allergy or severe sensitivity to milk and egg run the risk of serious or life-threatening allergic reaction if they consume these products.

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Evershing International Trading Company Recalls Frozen Shredded Coconut Because of Possible Health Risk - FDA Safety Alerts & Drug Recalls

Evershing International Trading Company is recalling 16 ounces Coconut Tree Brand Frozen Shredded Coconut because they have 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 system. 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 in to the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. No illnesses have been reported to date.

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Auromedics Pharma LLC Issues Voluntary Nationwide Recall of Product Ampicillin and Sulbactam for Injection USP 1.5 g/ Vial, Due to Presence of Glass Particles in the Vial - FDA Safety Alerts & Drug Recalls

AuroMedics Pharma LLC is voluntarily recalling lot AFO l 17001-A, Expiry date Dec 2018, of Ampicillin and Sulbactam for Injection USP, 1.5 g (equivalent to 1 g ampicillin as the sodium salt plus 0.5 g Sulbactam as the sodium salt) in a Single-Dose vial, to the hospital level. The product has been found to contain glass particles.

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California Popsicle, Inc. Issues Allergy Alert on Undeclared Milk in Ice Bars - FDA Safety Alerts & Drug Recalls

California Popsicle, Inc. dba Polly Ann Ice Cream of South San Francisco, CA is recalling ice bars, because it may contain 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 these products.

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Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices - FDA Press Releases

FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. FDA is releasing two documents that together will improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs).

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T. Marzetti Company Voluntarily Recalls Frozen Biscuit Dough Packed Under Various Brands Due to Potential Listeria Contamination - FDA Safety Alerts & Drug Recalls

As a precautionary measure, T. Marzetti Company is voluntarily recalling all “Best By” dates of the following products that were distributed in Alabama, Florida, Georgia, Indiana, Kentucky, Louisiana, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, and Virginia, because they may have the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is 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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PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products due to Lack of Sterility Assurance - FDA Safety Alerts & Drug Recalls

December 27, 2017 Lake Forest, IL PharMEDium Services, LLC (PharMEDium) is voluntarily recalling the below lots of drug products to the hospital/user level due to a lack of assurance of sterility. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, PharMEDium has not received any reports of complaints related to the products but is issuing this recall out of an abundance of caution following a commitment made during a recent inspection of the company’s facility.

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