Regulations Limiting Use of Potent Acne Drug During Pregnancy Work Most of the Time, UF Study Finds

Efforts to control the use of a potent anti-acne drug among pregnant women appear to be working, a University of Florida College of Pharmacy study has found, but there is room for improvement.

Isotretinoin is commonly used by adolescents and young adults to treat more severe cases of acne. Since it was first approved by the Food and Drug Administration in 1982, the drug has been heavily regulated by the agency to prevent its use during pregnancy. Chief among the concerns is that isotretinoin causes birth defects, including severe cardiac malformations.

“Isotretinoin is one of the most controlled drugs on the market, but no one has ever looked to what degree this level of control is successful,” said Almut Winterstein, R.Ph., Ph.D., FISPE, a professor, the Robert and Barbara Crisafi Chair in Pharmaceutical Outcomes and Policy in the College of Pharmacy and director of the Center for Drug Evaluation and Safety at UF. “This is the first study that assesses the risk of becoming pregnant while taking isotretinoin compared to other acne drugs.”

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