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Emergency Medicine and Surgery professionals have been informed by the FDA that the Agency has received several adverse events reports that may be related to a retrievable filter remaining in the body for long periods of time. Background of Inferior Vena Cava (IVC) Filters IVC filters are small, cage-like devices that are inserted into the [...]

Cardiology Healthcare Personnel and patients are warned by the FDA that Pradaxa (dabigatran etexilate mesylate) should not be used in patients with mechanical heart valves. Background of Pradaxa (dabigatran etexilate mesylate) Pradaxa (dabigatran etexilate mesylate) is an anti-coagulant or blood thinner which is used to minimize the risk of getting a stroke in patients. It [...]

Health Professionals, Patients and Home Caregivers are notified by the FDA about a change to the container and carton labels for heparin products in order to eliminate the risk of miscalculations. Background of Heparin Heparin is used: for preventing the formation of blood clots in people with certain medical conditions or under certain medical procedures [...]

Oncological, nephrological healthcare professionals and patients are notified by the US FDA and Amgen that all ESAs must be used under a REMS risk management program. FDA Alert on Erythropoiesis-Stimulating Agents (ESAs) FDA requires a REMS because studies have shown that ESAs (Procrit, Epogen and Aranesp) can increase the risk of tumor growth and shorten [...]