FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women

CodeineA search of the FDA Adverse Event Reporting System (FAERS) database from January 1969 to May 2015 identified 64 worldwide cases of respiratory depression, including 24 deaths, with codeine-containing medicines in children younger than 18 years. Fifty cases were reported in children younger than 12 years. Respiratory depression occurred after the children received a range…

FDA Adverse Events Reporting System (FAERS) Public Dashboard

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…

Dermatologic and Ophthalmic Drugs Advisory Committee Roster

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Assessment of Abuse Potential of Drugs

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