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FDA Update: Committee Recommends 2 mg Baricitinib Approval; HLH Identified as Serious Adverse Event for Lamotrigine

  |  Issue: June 2018  |  

Information about this serious adverse event with lamotrigine was added as a new warning to the prescribing information.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

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References

  1. Eli Lilly and Company. New release: FDA Advisory Committee recommends the approval of baricitinib 2 mg, but not 4 mg, for the treatment of moderately to severely active rheumatoid arthritis. 2018 Apr 23.
  2. U.S. Food and Drug Administration. Drug safety announcement: FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal). 2018 Apr 25.

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