Public Summary

The following 4 Drug Safety Communications have posted since the September 18, 2020 DSOB meeting.

• February 4, 2021: Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)
  • FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available.
  • FDA will communicate final conclusions and recommendations when the review is complete or when there is more information to share.

• October 15, 2020: FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid
  • For prescription NSAIDS, FDA is requiring changes to the prescribing information to describe the risk of kidney problems in unborn babies that result in low amniotic fluid. FDA is recommending avoiding NSAIDs in pregnant women at 20 weeks or later in pregnancy rather than the 30 weeks currently described in NSAID prescribing information.
  • FDA will also update the Drug Facts labels of OTC NSAIDs intended for use in adults.

• September 24, 2020: FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)
  • FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine diphenhydramine (Benadryl) can lead to serious heart problems, seizures, coma, or even death.
    • FDA became aware of news reports of teenagers ending up in emergency rooms or dying after participating in the “Benadryl Challenge” encouraged in videos posted on the social media application TikTok.
    • FDA is investigating these reports and conducting a review to determine if additional cases have been reported.

• September 23, 2020: FDA required Boxed Warning be updated to improve safe use of benzodiazepine drug class
  • FDA is requiring that the Boxed Warning be updated for all benzodiazepine medications and has also required changes in other sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.
    • FDA reviewed postmarketing databases, adverse event cases reported to FAERS database, and the published literature on abuse, misuse, addiction, dependence, and withdrawal associated with benzodiazepine use
      • Found benzodiazepines are:
        • widely prescribed in the U.S., often for long periods of times;
        • widely abused and misused, often together with alcohol, prescription opioids, and illicit drugs, which worsen the risks of serious problems;
      • Found that some patients have had serious withdrawal reactions after benzodiazepines were stopped suddenly or the dose was reduced too quickly. Some patients experienced withdrawal symptoms lasting many months.

There was one presentation to the Board: Biosimilar and Interchangeable Biological Products (Sarah Yim, M.D. Director, Office of Therapeutic Biologics and Biosimilars, CDER; Sarah Ikenberry, M.A. Senior Communication Advisor, Office of Therapeutic Biologics and Biosimilars, CDER)

Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or institution.

Additional Information

• Drug Safety Oversight Board Members (PDF - 32KB)