FDA warns of increased pregnancy risk for Myfortic

November 29, 2007

Evidence of fetal risk reported for mycophenolic acid (Myfortic, Novartis)

Following postmarketing reports of pregnancy loss and congenital malformations in women exposed to the active ingredient of mycophenolate mofetil (MMF), mycophenolic acid, or MPA (Myfortic, Novartis), the FDA has sent out a Dear Healthcare Professional Letter informing clinicians of a change in status for the drug from Pregnancy Category C to Category D, a class including drugs that have shown positive evidence of fetal risk. As part of the change, the FDA encourages providers to discuss the risks and benefits of the drug as well as alternative treatments with patients. Contraceptive counseling should also be provided to women of childbearing age, and effective contraception should be used while taking the drug. The immunosuppressant is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplant in combination with corticosteroids and cyclosporine. MMF is converted to MPA, and both drugs are considered to have the same teratogenic risk in humans. The FDA has requested that manufacturers of all MMF and MPA products update their labeling to reflect the new findings.

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