Category Archives: FDA Notice

Rosiglitazone containing Diabetes Medicines Drug Safety Communication

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Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication – Removal of Some Prescribing and Dispensing Restrictionsincluding Avandia, Avandamet, Avandaryl, and generics AUDIENCE: Family Care, Endocrinology, Cardiology ISSUE: FDA has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and … Continue reading

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Meridian Medical Technologies Auto-Injectors Extension of Expiration Dates

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Meridian Medical Technologies Auto-Injectors: Extension of Expiration Dates including Auto-Injectors for Atropen (atropine)DuoDote (atropine/pralidoxime chloride)morphine sulfatepralidoxime chloridediazepam AUDIENCE: Emergency Medicine,¬†Pharmacy ISSUE: FDA is aware of a disruption in supply to health care providers and emergency response personnel of Atropen (atropine), … Continue reading

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St Jude Amplatzer Atrial Septal Occluder ASO Safety Communication

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St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication – Reports of Tissue Erosion AUDIENCE: Cardiology, Risk Manager, Patient ISSUE: FDA is alerting health care providers and patients that in very rare instances, tissue surrounding the Amplatzer ASO can break … Continue reading

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Avance Aisys And Avance CS2 Anesthesia Delivery Systems

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Avance, Aisys And Avance CS2 Anesthesia Delivery Systems: Voluntary Field Corrective Action – Potential Safety Issue AUDIENCE: Risk Manager, Anesthesiology, Health Professional ISSUE: GE Healthcare has initiated a voluntary field corrective¬† for the Avance, Aisys and Avance CS2 anesthesia delivery¬†systems … Continue reading

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Gilenya fingolimod Drug Safety Communication

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Gilenya (fingolimod) – Drug Safety Communication: Investigating Rare Brain Infection AUDIENCE: Neurology, Pharmacy ISSUE: FDA is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking … Continue reading

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Acetaminophen Drug Safety Communication

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Acetaminophen: Drug Safety Communication – Association with Risk of Serious Skin Reactions AUDIENCE: Dermatology, Primary Care, Pharmacy ISSUE: FDA notified healthcare professionals and patients that acetaminophen has been associated with a risk of rare but serious skin reactions. Acetaminophen is … Continue reading

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Healthy Life Chemistry By Purity First B 50

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Healthy Life Chemistry By Purity First B-50: FDA Health Risk Warning – Undeclared Ingredients [UPDATE 8/01/2013] – Purity First Health Products is recalling two lots of Healthy Life Chemistry B-50 (100 capsules), one lot of Healthy Life Chemistry Multi-Mineral (200 … Continue reading

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Diabetes Treatments FDA Alerts of Illegal Sales Undeclared Ingredients

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Diabetes Treatments: FDA Alerts of Illegal Sales – Undeclared Ingredients AUDIENCE: Consumer, Health Professional ISSUE: FDA is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent … Continue reading

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MedWatch June 2013 Safety Labeling Changes

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The MedWatch June 2013 Safety Labeling Changes posting includes over 44 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT. The “Summary Page” provides a listing of product names … Continue reading

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Cybersecurity for Medical Devices and Hospital Networks

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Cybersecurity for Medical Devices and Hospital Networks: FDA Safety Communication AUDIENCE: Biomedical Engineering, Health Professional, Risk Manager ISSUE: FDA is recommending that medical device manufacturers and health care facilities take steps to assure that appropriate safeguards are in place to … Continue reading

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Posted in Biomedical Engineering, FDA 2013, FDA Notice, FDA Safety Communication, Healthcare Professionals, Risk Manager | Tagged , , , , , , , , | Comments Off on Cybersecurity for Medical Devices and Hospital Networks