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CDER Statement: FDA alerts pharmacies to concerns with testing conducted by Front Range Laboratories
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Warning on Stolen Albuterol Sulfate Inhalation Solution and Ipratropium Bromide Inhalation Solution
On September 17, 2009, the U.S. Food and Drug Administration (FDA) advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept….
Update to FDA Alert About Stolen Insulin
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FDA Advisory About Levemir Insulin
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FDA Drug Safety Communication:Â FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection
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Drug Safety Oversight Board Meeting, March 18, 2010
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Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte que el medicamento antipirético y analgésico acetaminofén (paracetamol) puede causar reacciones poco comunes pero serias en la piel
Resumen de datos La FDA analizó la base de datos del Sistema de Reportaje de Reportaje de Eventos Adversos (AERS) y la literatura médica en busca de una asociación entre el acetaminofén y el sÃndrome de Stevens-Johnson (SJS), necrólisis epidérmica tóxica (TEN) y pustulosis exantemática generalizada aguda (AGEP). La evidencia que indica causalidad entre el…
FDA Drug Safety Communication: FDA warns of rare but serious skin reactions with the pain reliever/fever reducer acetaminophen
Data Summary FDA reviewed the FDA Adverse Event Reporting System (FAERS) database and the medical literature for evidence of an association between acetaminophen and Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). Â The evidence supporting causality between acetaminophen and serious skin reactions primarily comes from a small number of published…
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA limita el uso de tabletas orales de Nizoral (ketoconazol) debido a lesiones potencialmente fatales al hÃgado y riesgo de interacción con medicamentos y problemas de las glándulas suprarrenales
Anuncio de seguridad El 26 de julio, 2013, La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) está tomando varias medidas relacionadas con las tabletas orales de Nizoral (ketoconazol), entre ellas limitar el uso del medicamento, advertir que puede causar lesiones severas al hÃgado y problemas de las glándulas…