FDA Designates Medtronic Worldwide Voluntary Field Action on HVAD(TM) System Controllers and DC Adapters as Class I Recall - FDA Safety Alerts & Drug Recalls

Medtronic plc (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to its HVAD(TM) System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435) as a Class I recall.

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FDA approves new combination treatment for acute myeloid leukemia - FDA Press Releases

The U.S. Food and Drug Administration today approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML.

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Urban Remedy Issues Voluntary Recall of Mislabeled Non-Dairy Spiced Golden Milk Due to Undeclared Allergen - FDA Safety Alerts & Drug Recalls

Urban Remedy is voluntarily recalling Non-Dairy Spiced Golden Milk that was mislabeled as cold pressed apple juice. The products were sold in select Whole Foods Market stores in Arizona, California and Nevada and contained tree nut (cashew) allergens that were not listed on the product labels. People who have an allergy or severe sensitivity to tree nuts run the risk of serious or life-threatening allergic reaction if they consume these products.

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Falls in the Aging Population - Geriatrics

The number of people living beyond 65 years of age is increasing rapidly and they are at increased risk of falls. Falls-related injuries and hospitalizations are steadily increasing. Falls can lead to fear of falling, loss of independence, institutionalization, and death, inevitably posing a significant burden to the health care system. Therefore, screening of people at risk of falls and comprehensive assessment of older people at high risk of falls are critical steps toward prevention. This review evaluates the current knowledge relating to falls, with particular focus on rapid screening, assessment, and strategies to prevent falls in the community.

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Lords Organics Recalls Ginger Powder Because Of Possible Health Risk - FDA Safety Alerts & Drug Recalls

LORDS ORGANICS is recalling Ginger Powder Product from AGF Organic Veda, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

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Survival, Functional Status, and Eating Ability After Percutaneous Endoscopic Gastrostomy Tube Placement for Acute Stroke - American Geriatric Society

Objectives

To determine the long-term survival and independence of individuals with stroke and percutaneous endoscopic gastrostomy (PEG) tube placement.

Design

Retrospective cohort study.

Setting

A longitudinal nationally representative community-based sample of older adults.

Participants

Individuals with stroke who had a PEG tube placed (N = 174, mean age 79, 51% female, 29% African American).

Measurements

Functional status before incident stroke was determined based on data from the Health and Retirement Study (HRS), a national longitudinal survey of community-dwelling older adults, from 1993 to 2012. Hospitalizations for stroke and PEG placement were determined according to Medicare claims. HRS participants were interviewed, and outcomes of survivors interviewed in the 2 years after hospitalization are described. Survival and functional and eating ability of the cohort were examined. Groups were compared according to age and prestroke functional disability in activities of daily living (ADLs) because it was hypothesized that ADL disability would predict worse outcomes.

Results

In the 2 years after hospitalization, overall mortality was 66%. Fifteen participants survived and regained independent ADL function (9%). Of those who survived to a follow-up interview, 33 (56%) could not eat independently, and 31 (53%) required assistance to walk across the room. Age of 85 and older was associated with worse outcomes (10% vs 29% at 2 years, P < .001), but baseline ADL disability was not.

Conclusion

In this community-based sample, individuals who had had a stroke and a PEG tube placed had high mortality, and survivors were unlikely to be functional or mobile or to recover eating ability after hospitalization. A palliative care discussion including goals of care should occur before PEG tube placement is considered.

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Caregiving for Older Adults with Obesity in the United States - American Geriatric Society

Objectives

To determine the difference in receipt of activity of daily living (ADL) assistance between obese and normal-weight older adults.

Design

Retrospective cohort study.

Setting

National Health and Aging Trends Study, 2011–2015.

Participants

U.S. adults aged 65 and older with ADL disability and a body mass index (BMI) of 18.5 kg/m² or greater (N = 5,612)

Measurements

BMI was classified as normal weight (18.5–24.9 kg/m²), overweight (25.0–29.9 kg/m²), or obese (≥30.0 kg/m²). Primary outcome was self-reported receipt of help with specific ADLs. Models were adjusted for demographic characteristics (age, sex, race), degree of need (self-reported general health, severity of disability), household resources (income, marriage, people in household, number of children), and cognitive status (dementia, proxy respondent).

Results

Obese with disabilities had lower rates of receiving assistance with walking inside (odds ratio (OR) = 0.63, 95% confidence interval (CI) = 0.50–0.81), walking outside (OR = 0.76, 95% CI = 0.59–0.97), toileting (OR = 0.68, 95% CI = 0.52–0.89), and getting in and out of bed (OR = 0.67, 95% CI = 0.50–0.87) than normal-weight older adults after adjustment for respondent demographic characteristics. Level of need and cognitive status partially explained the associations. In fully adjusted models, older adults with obesity still had significantly lower odds of receiving assistance in getting in and out of bed than normal weight adults (OR = 0.69, 95% CI = 0.49–0.98).

Conclusion

Older adults with obesity are less likely to receive assistance for ADL disabilities than their normal-weight counterparts—an important concern because of ongoing demographic changes in the United States.

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