Esta actualización se hace a manera de seguimiento al Comunicado de la FDA sobre la seguridad de los medicamentos del 7/12/2011: Estudio de seguridad sobre informes posteriores al lanzamiento al mercado sobre eventos de hemorragias severas con el anticoagulante Pradaxa (dabigatrán etexilato mesilato) Anuncio de seguridadInformación adicional para consumidores y padres de familia/cuidadoresInformación adicional para…
FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa
This update is a follow-up to the FDA Drug Safety Communication of 12/7/2011: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate) Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary References Safety Announcement [11-02-2012] The U.S. Food and Drug Administration (FDA) has evaluated new information about…
Multistate outbreak of fungal meningitis and other infections
FDA provides NECC Customer List [10-22-2012] On October 4, 2012, FDA advised medical professionals that all products produced by New England Compounding Center (NECC) should be retained, secured, and withheld from use. On October 6, NECC announced a voluntary recall of all its products currently in circulation that were compounded at and distributed from its…
Comunicado de la FDA sobre la seguridad de los medicamentos: Sucesos adversos graves resultantes de ingestión accidental por niños de colirios (gotas para los ojos) y aerosoles nasales de venta libre
Anuncio de seguridadInformación adicional para consumidores y padres de familia/cuidadoresInformación adicional para profesionales de la saludResumen de datosLista de productosReferencias  Anuncio de seguridad El 25 de octubre del 2012 La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) le advirtió al público que si los niños ingieren accidentalmente…
Truthful Prescription Drug Advertising and Promotion
 FDA’s Bad Ad program is an outreach program designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading. The Bad Ad Program is administered by the agency’s Office of Prescription Drug Promotion (OPDP) in the Center for Drug…
Update on Fungal Meningitis
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Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) (formerly AERS)
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Drug Establishments Current Registration Site
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Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de seguridad en curso sobre el medicamento Mirapex (pramipexole) para la enfermedad de Parkinson y el posible riesgo de insuficiencia cardÃaca
Anuncio de seguridadInformación adicional para consumidoresInformación adicional para profesionales de la saludResumen de datosReferencias  Anuncio de seguridad 19 de septiembre del 2012. La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) le informó al público sobre la posibilidad de un mayor riesgo de insuficiencia cardÃaca con Mirapex (pramipexole),…
FDA Drug Safety Communication: Rare cases of serious burns with the use of over-the-counter topical muscle and joint pain relievers
Safety AnnouncementAdditional Information for ConsumersAdditional Information for Health Care ProfessionalsData SummaryReferences Safety Announcement [9-13-2012] The U.S. Food and Drug Administration (FDA) is alerting the public that certain over-the-counter (OTC) products that are applied to the skin for the relief of mild muscle and joint pain have been reported to cause rare cases of serious skin…