What is FDA Posting? Why is FDA posting this summary information? What information is provided on this website? What information does FDA consider for these postmarket safety evaluations? How is the information analyzed? Postmarket Drug Safety Evaluation Summaries  October 2013 – December 2013 previous summaries What is FDA posting? This website provides summary information about ongoing…
FDA Drug Safety Communication: FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning
Data Summary FDA continues to monitor reports of toxicity with the use of prescription oral viscous lidocaine and over-the-counter (OTC) benzocaine to treat teething pain in infants and young children. A search of FDA’s Adverse Event Reporting System (FAERS) database and the medical literature through December 2013 identified 22 cases of toxicity with the use…
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte sobre reacciones poco frecuentes pero serias de hipersensibilidad a ciertos productos para el acné de uso tópico y venta libre
Anuncio de seguridad [6-25-2014] La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA por su sigla en inglés) advirtió acerca de ciertos productos para el acné de uso tópico y venta libre que pueden causar irritación severa o reacciones alérgicas poco frecuentes pero serias y hasta potencialmente mortales. Los consumidores deben dejar de…
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…
FDA Drug Safety Communication: FDA warns that cancer drug docetaxel may cause symptoms of alcohol intoxication after treatment
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Drug-Induced Liver Injury: Premarketing Clinical Evaluation
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Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications
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Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events
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Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage
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