Ask the Expert Live Webinar: Do We Need REMS?-Ask the Experts On Demand Webinar: Do We Need Rems

Video Transcription

Video Summary

The webinar explored the role of REMS (Risk Evaluation and Mitigation Strategies) in drug safety and whether they are truly needed. Dr. Almut Winterstein reviewed major drug-safety milestones, from the sulfonamide and thalidomide disasters to Vioxx and the FDA Amendments Act, which established REMS. She explained that REMS are used when a drug’s serious risks require more than standard labeling, especially when unsafe real-world use could worsen outcomes.<br /><br />Examples included cisapride, where FDA warnings failed to change unsafe prescribing, and REMS drugs used in neurology such as vigabatrin, topiramate-phentermine, and fenfluramine. She showed that REMS can reduce unsafe pregnancy exposure, especially when they include strong safeguards like pregnancy testing and restricted dispensing. However, some REMS appear less effective, as with mycophenolate, where provider education helped but conception during use remained unchanged.<br /><br />A major focus was valproic acid, a potent teratogen widely used outside epilepsy. Dr. Winterstein argued that the lack of a REMS for valproate is concerning, given persistent prenatal exposure and serious fetal risks. She concluded that REMS can be useful when they target the right weak point in the safety chain, but they can also create burden and reduce access.

Asset Subtitle

Recording from Live Session.

Keywords

REMS

drug safety

FDA Amendments Act

valproic acid

teratogenicity

pregnancy exposure

risk mitigation

cisapride

mycophenolate