The FDA Adverse Event Reporting System (FAERS) contains over nine million reports of adverse events and reflects data from 1969 to the present. FDA moved data from our legacy system (AERS) to FAERS on August 28, 2012. Data from FAERS are presented here as summary statistics. These summary statistics cover…
FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder
The U.S. Food and Drug Administration (FDA) is warning that Viberzi (eluxadoline), a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in patients who do not have a gallbladder. An FDA review found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or…
Oncologic Drugs Advisory Committee Roster
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Orange Book Data Files
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La FDA advierte acerca de reacciones alérgicas poco comunes pero graves del antiséptico tópico con gluconato de clorhexidina
La Administración de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en inglés) advierte que se han reportado reacciones alérgicas poco comunes pero graves con los ampliamente utilizados productos antisépticos tópicos que contienen gluconato de clorhexidina. Si bien son poco comunes, el número de reportes de reacciones alérgicas graves por estos productos ha…
Dear Health Care Provider Letters: Improving Communication of Important Safety Information
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Gammaplex 5% & 10%
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Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
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FDA Drug Safety Communication: FDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate
The U.S. Food and Drug Administration (FDA) is warning that rare but serious allergic reactions have been reported with the widely used skin antiseptic products containing chlorhexidine gluconate. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. As a result, we are requesting the…
Dermatologic and Ophthalmic Drugs Advisory Committee Roster
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