[Posted 09/13/2019] AUDIENCE: Patient, Health Professional, Oncology ISSUE: 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. FDA has approved new warnings about this risk to the prescribing information and Patient Package Insert for the entire…

[Posted 09/06/2019] AUDIENCE: Consumer, Health Professional BACKGROUND: 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 U.S. Centers for Disease Control and Prevention, as well as state and local public health partners to investigate…

[Posted 08/30/2019] AUDIENCE: Consumer, Critical Care Medicine, Emergency Medicine, Health Professional, Pulmonology  ISSUE: As of Aug. 27, 2019, 215 possible cases have been reported from 25 states, and additional reports of pulmonary illness are under investigation. States are completing their own investigations and verifications of cases based on Center for Disease Control and Prevention (CDC) recently…

[Posted 08/28/2019] AUDIENCE: Gastroenterology, Infectious Disease, Health Professional, Patient, Pharmacy  ISSUE: 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. FDA identified 63 cases of worsening liver function called…

[Posted 07/26/2019] AUDIENCE: Patient, Health Professional, Pharmacy, Gastroenterology, Rheumatology ISSUE: FDA has approved new warnings about an increased risk of blood clots and of death with the 10 mg twice daily dose of Xeljanz, Xeljanz XR (tofacitinib), which is used in patients with ulcerative colitis. In addition, the approved use of tofacitinib for ulcerative colitis will…

[Posted 06/13/2019] AUDIENCE: Patient, Healthcare Professional ISSUE: The FDA is now aware of bacterial infections caused by multi-drug resistant organisms (MDROs) that have occurred due to transmission of a MDRO from use of investigational fecal microbiota for transplantation (FMT): Two immunocompromised adults who received investigational FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli…

[Posted 04/03/2019]  AUDIENCE: Consumers, Emergency Medicine, Health Professionals  ISSUE: The FDA has become aware that some people who use e-cigarettes have experienced seizures, with most reports involving youth or young adult users. Seizures or convulsions are known potential side effects of nicotine toxicity and have been reported in the scientific literature in relation to intentional…

[Posted 04/30/2019] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: FDA is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more…