[3-14-2013] The U.S. Food and Drug Administration (FDA) is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These…
FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms
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FDA Drug Safety Communication: Pediatric clinical studies of Sensipar (cinacalcet hydrochloride) suspended after report of death
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FDA Drug Safety Communication: FDA suspends pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after report of death
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FDA Drug Safety Communication: Safety review update of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy
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Acetaminophen Toxicity
Acetaminophen is one of the most commonly used medicines in the United States. When used according to the label directions, it has a well-established record of safety and efficacy. Although acetaminophen overdose is very rare in the context of its broad usage, overdose can be toxic and lead to acute liver failure. Liver injury from…
FDA Drug Safety Communication: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)
questions and answers to provide an additional overview of this safety issue.
Comunicado de la FDA sobre la seguridad de los medicamentos: Riesgo de aletargamiento o menor nivel de alerta mental la mañana posterior al uso de medicamentos contra el insomnio; la FDA requiere reducir la dosis recomendada para ciertos medicamentos que contienen zolpidem
Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de datosDosis recomendada de zolpidem para adultos (no ancianos)Medicamentos para el insomnio Referencias Anuncio de seguridad El 10 de enero del 2013, La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) notificó al público de nueva información…
Comunicado de la FDA sobre la seguridad de los medicamentos: Pradaxa (dabigatrán etexilato mesilato) no se debe usar en pacientes con válvulas protésicas del corazón
Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de datos  Anuncio de seguridad El 19 de diciembre del 2012, La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público y profesionales de la salud que el anticoagulante Pradaxa (dabigatrán etexilato mesilato) no…