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MedWatch Safety Alert

Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety Communication - Due to Rare but Severe Lung Inflammation

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.


Zantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicines

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


Tetrahydrocannabinol (THC)-containing Vaping Products: Vaping Illnesses

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.


E-Cigarette Products: Safety Communication - Due to the Incidents of Severe Respiratory Disease Associated with Use of an E-Cigarette Product

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.


Hepatitis C Medicines (Mavyret, Zepatier, and Vosevi): Drug Safety Communication - Due to Rare Occurrence of Serious Liver Injury in Some patients with Advanced Liver Disease

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.


Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Due to an Increased Risk of Blood Clots and Death with Higher Dose

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


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

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


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

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


Certain Prescription Insomnia Medicines: New Boxed Warning - Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake

MedWatch Alert on certain prescription insomnia medicines.