Eluxadoline (Viberzi®) may cause serious, life-threatening pancreatitis in patients without a gallbladder.

Kingsway Trading Inc. is recalling its dietary supplement Well Balance Xanthium & Siler Combo (Bi Yan Pian) due to the presence of ephedra herba (ma huang) in the product.

Due to increases in reports of anaphylaxis, a warning is now being added to the OTC Drug Facts labels.

FDA is informing patients and health care professionals that magnetic resonance (MR) environments can cause implantable infusion pump errors resulting in patient harm and death.

FDA received a cluster of bleeding event reports in 2016 associated with the Vascu-Guard Peripheral Vascular Patch from Baxter International.

FDA is adding a new boxed warning to all opioid medications and benzodiazepines about the risk of serious adverse effects with concomitant use. FDA reviewed 6 studies regarding opioid use...