FDA approves REMS to warn of birth defects.

Dow Jones Newswire (9/25, Dooren) reports that the Food and Drug Administration on Tuesday announced it has approved a Risk Evaluation and Mitigation Strategy system for organ-transplant drugs that contain mycophenolate, which is an immunosuppressive agent and can cause birth defects if taken during pregnancy. The agency said the Mycophenolate REMS, which includes a training guide for healthcare providers and a medication guide they can distribute to patients, will establish a registry in which pregnant women will be given the option to participate. The FDA noted that approximately, 20 percent of babies exposed to mycophenolate during their mothers' pregnancies were born with congenital malformations.