[11-25-2014] The U.S. Food and Drug Administration (FDA) is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate), developed a rare and serious brain infection called PML, and later died. As a result, information describing this case of PML, or progressive multifocal leukoencephalopathy, is being added to the…
Key Points of the Bad Ad Program
What is the Bad Ad Program? The Bad Ad Program is an FDA-sponsored outreach program designed to educate health care professionals about the role they can play in helping FDA ensure that prescription drug advertising and promotion is truthful and not misleading. The program helps health care professionals who prescribe medications or otherwise make selection…
FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events
A U.S. Food and Drug Administration (FDA) review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, we have added information about these…
FDA Drug Info Rounds Video
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Status of OTC Rulemakings
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Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)
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Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA)
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FDA Drug Safety Communication: Increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections
Safety AnnouncementAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [09-01-2010] The U.S. Food and Drug Administration (FDA) is reminding healthcare professionals of an increased mortality risk associated with the use of the intravenous antibacterial Tygacil (tigecycline) compared to that of other drugs used to treat a variety of serious infections. The increased risk…
Comunicado de la FDA sobre la seguridad de los medicamentos: No es concluyente el análisis de la FDA de riesgos cardiovasculares para diabéticos que toman el medicamento para la hipertensión olmesartán; se requieren actualizaciones a la etiqueta
Resumen de datos FDA has completado un análisis de seguridad de olmesartán y riesgos cardiovasculares que fue motivado por los resultados del estudio ROADMAP (Randomized Olmesartan and Diabetes MicroAlbuminuria Prevention) y ORIENT (Olmesartan Reducing Incidence of End Stage Renal Disease in Diabetic Nephropathy Trial). Estos estudios indicaron que una dosis alta de olmesartán puede aumentar…
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA recomienda no usar lidocaÃna para el tratamiento del dolor por dentición y requiere nuevo Recuadro de advertencia
Anuncio de seguridad [6-26-2014] La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por su sigla en inglés) advirtió que la solución de lidocaÃna viscosa al 2 por ciento para uso oral y de venta con receta médica, no se debe usar en el tratamiento del dolor por dentición de bebés o niños. Estamos…