FDA expands use of Sapien 3 artificial heart valve for high-risk patients - FDA Press Releases

The U.S. Food and Drug Administration today approved an expanded indication for the Sapien 3 Transcatheter Heart Valve (THV) for patients with symptomatic heart disease due to failure of a previously placed bioprosthetic aortic or mitral valve whose risk of death or severe complications from repeat surgery is high or greater.

from Food and Drug Administration--Press Releases http://ift.tt/2sKLVsS
via IFTTT

Naturally Wholesome Products LLC Wholesome Country Creamery LLC Voluntary recall of Half & Half in plastic gallon and pint bottles, due to the presence of Alkaline Phosphatase in samples - FDA Safety Alerts & Drug Recalls

Naturally Wholesome Products LLC is voluntarily recalling gallon and pint containers of Half & Half labeled under the brand name Wholesome Country Creamery due to the presence of Alkaline Phosphatase found in samples during routine testing. Naturally Wholesome Products LLC has received no reports of illnesses related to the affected product and is removing the product from the market out of the abundance of caution.

from Food and Drug Administration--Recalls/Safety Alerts http://ift.tt/2rtDeWk
via IFTTT

Gilster-Mary Lee Corp. Issues a Recall For Undeclared Egg Noodles in Western Family Onion Soup Mix - FDA Safety Alerts & Drug Recalls

Gilster-Mary Lee of Chester, Illinois, is voluntarily recalling one lot of Western Family Onion Soup Mix, UPC 15400-03604 because it may contain undeclared egg. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

from Food and Drug Administration--Recalls/Safety Alerts http://ift.tt/2rKX7Zv
via IFTTT

Influence of Hospital Type on Outcomes of Individuals Aged 80 and Older with Stroke Treated Using Intravenous Thrombolysis - American Geriatric Society

Objectives

The aim of the study was to confirm the safety and effectiveness of using intravenous thrombolysis (IVT) with individuals aged 80 and older in routine practice in different hospital settings.

Design

Observasional registry.

Setting

Prospective multicenter population-based registry of acute stroke patients treated with reperfusion therapies in Catalonia, Spain (Sistema Online d'Informació de l'Ictus Agut).

Participants

Individuals treated only with IVT (N = 3,231; 1,189 (36.8%) aged ≥80).

Measurements

Symptomatic intracranial hemorrhage, mortality, and favorable outcome (modified Rankin Scale (mRS) score = 0–2) at 3 months were evaluated according to hospital characteristics. Treating hospitals were classified in three categories: comprehensive stroke centers (CSCs), primary stroke centers (PSCs), and community hospitals operating a telestroke system (TS). First individuals aged 80 and older were compared with those younger than 80, and then participants aged 80 and older were focused on.

Results

Participants aged 80 and older had significantly higher baseline National Institute of Health Stroke Scale (NIHSS) scores, longer onset to treatment times, and worse outcomes than younger participants. For participants aged 80 and older, 90-day mortality was 23.2%, with 38.7% having favorable outcomes at 3 months. Symptomatic intracranial hemorrhage (SICH; Safe Implementation of Thrombolysis in Stroke-MOnitoring STudy definition) was observed in 4.7% of subjects. None of the risk factors differed significantly between participants treated in different types of hospitals. Basal stroke severity measured according to NIHSS score was not significantly different either. The three different types of hospitals achieved similar outcomes, although the TS and PSC hospitals had significantly higher proportions of SICH (6.3% and 6.3%, respectively) than the CSC (3.2%).

Conclusion

Older adults with acute stroke treated with IVT had similar outcomes regardless of hospital characteristics.

from Journal of the American Geriatrics Society http://ift.tt/2qJNrz7
via IFTTT

Schnucks Bakery Issues Allergy Alert on Undeclared Walnuts in Cinnamon Pudding Half Cakes and Cake Slices - FDA Safety Alerts & Drug Recalls

Cinnamon Pudding Half Cakes and Cake Slices

from Food and Drug Administration--Recalls/Safety Alerts http://ift.tt/2qGYZz4
via IFTTT

Hannaford Supermarkets Issues Allergy Alert on Undeclared Milk in Taste of Inspirations Greek Pasta Salad Net. Weight 10 oz. (284g) - FDA Safety Alerts & Drug Recalls

A.S.K. Foods, Inc. of Palmyra, Pennsylvania is voluntarily recalling one lot of Hannaford Supermarkets’ TASTE OF INSPIRATIONS GREEK PASTA SALAD Net Wt. 10 oz. (284g) 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.

from Food and Drug Administration--Recalls/Safety Alerts http://ift.tt/2siX2tJ
via IFTTT

When It Comes to Older Adults, Language Matters: Journal of the American Geriatrics Society Adopts Modified American Medical Association Style - American Geriatric Society

from Journal of the American Geriatrics Society http://ift.tt/2qCwhUd
via IFTTT