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  5. Drug Safety Oversight Board (DSOB) Meeting March 31, 2021
  1. Center for Drug Evaluation and Research | CDER

Drug Safety Oversight Board (DSOB) Meeting March 31, 2021


Public Summary

The following 2 Drug Safety Communications have posted since the February 18, 2021 DSOB meeting.

  • March 31, 2021: Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease
    • FDA wants to evaluate whether other medicines in the same drug class have similar effects on the heart and are requiring safety studies on those also
  • March 25, 2021: FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harm
    • Reports of individuals abusing and misusing propylhexedrine have increased in recent years.
    • FDA is requesting that all manufacturers of OTC propylhexedrine nasal decongestant inhalers consider product design change that support its safety use. In addition, decreasing the amount of medicine the device contains could also reduce the risk of serious side effects if abused or misused.

There was one presentation to the Board: Overview of the Executive Order on America’s Supply Chain (Jacqueline Corrigan- Curay, J.D., M.D.., Director, Office of Medical Policy)

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

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