Valproate products are FDA-approved drugs to treat seizures.  Some valproate products are also approved to treat manic or mixed episodes associated with bipolar disorder (manic-depressive disorder), or […]

The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period April – June […]

The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period October – […]

Adenosine is a cardiac drug that is used for the treatment of paroxysmal supraventricular tachycardia (PSVT) including that associated with accessory bypass tracts (Wolff-Parkinson-White syndrome). Adverse […]

[11-04-2011] The U.S. Food and Drug Administration (FDA) is reminding healthcare providers and patients about the need to enroll in the Avandia-Rosiglitazone Medicines Access Program by […]

For 2010 information on Risk Evaluation and Mitigation Strategy (REMS) please see the FDA Archive Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData SummaryReferences Safety […]

(en Español) Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [3-28-2012] The U.S. Food and Drug Administration (FDA) is clarifying dosing and […]

(en Español) Safety Announcement [4-10-2012] The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood […]