UF Study Finds FDA Strategy Cuts Fetal Exposure to Harmful Immunosuppressive Drug, but Risks Remain

University of Florida researchers determined an FDA-approved program deters pregnant women from starting a potentially harmful immunosuppressive drug. But for women taking the drug, the program was not effective at reducing conception.

Mycophenolate helps prevent organ rejection after transplantation and is increasingly used for a variety of autoimmune disorders such as lupus or psoriasis. However, studies suggest mycophenolate also can increase the risk of miscarriage and birth defects, so it is not recommended for use during pregnancy.

“As chair of the drug safety and risk management advisory committee for the FDA, I was oftentimes faced with the need to make Risk Evaluation and Mitigation Strategy (REMS) program recommendations for drugs with certain safety concerns,” said Almut Winterstein, R.Ph., Ph.D., FISPE, a professor and the Dr. Robert and Barbara Crisafi Chair in Pharmaceutical Outcomes and Policy in the UF College of Pharmacy and the director of the UF Center for Drug Evaluation and Safety.

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