FDA Drug Safety Communication: FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products

Safety Announcement [6-25-2014] The U.S. Food and Drug Administration (FDA) is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation.  Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness;…

FDA Drug Safety Communication: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required

Data Summary  FDA has completed a safety review of olmesartan and cardiovascular risk that was prompted by results of the ROADMAP (Randomized OlmesArtan and Diabetes MicroAlbuminuria Prevention) trial and ORIENT (Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial).  These studies suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic…

Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events

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