MedWatch Safety Alerts

Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults

MedWatch Alert on certain prescription insomnia medicines.

Drug Safety Communication - Due to an Increased Risk of Blood Clots and Death with Higher Dose

FDA MedWatch Alert regarding Fecal Microbiota for Transplantation: Safety Communication- Risk of Serious Adverse Reactions Due to Transmission of Multi-Drug Resistant Organisms

FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.

Both the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are working tirelessly to investigate the distressing incidents of severe respiratory disease associated with use of e-cigarette products.

Consumers are likely aware of the recent reports of respiratory illnesses – including some resulting in deaths – following the use of vaping products.The FDA is working closely with the CDC, as well as state and local public health partners to investigate them as quickly as possible.

FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain NDMA.

FDA is warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs.