Mycophenolate mofetil and mycophenolic acid linked to spontaneous abortion and birth defects

June 16, 2008

FDA issues warning to healthcare professionals about Roche and Novartis' transplant drugs.

The Food & Drug Administration has issued a warning to healthcare professionals about an increased risk of spontaneous abortion during the first trimester of pregnancy and an increased risk of birth defects for women taking mycophenolate mofetil (CellCept, Roche) or mycophenolic acid (Myfortic, Novartis). Both drugs are FDA approved as immunosuppressants used to prevent organ transplant rejection and are used off-label to treat systemic lupus erythematosus, rheumatoid arthritis, and erythema multiforme. Providers should confirm that patients are not pregnant and are using effective birth control measures to prevent pregnancy prior to treatment. In addition, women who are planning to become pregnant should discuss the risk with their physicians and whether or not an alternate immunosuppressant may be necessary. The FDA revised the labeling for both drugs in November 2007 to include boxed warning information concerning spontaneous abortion and birth defects.