On December 6, 2007, the United States Food and Drug Administration (FDA) issued a MedWatch Alert for Novartis? Myfortic. The kidney transplant drug now carries a ?black box? warning ? the FDA?s strongest ? advising users of the increased risk of pregnancy loss and congenital malformations associated with using the drug.

Myfortic is a drug manufactured to aid kidney transplant patients. A patient?s immune system usually recognizes a new kidney as something foreign, and may attack or reject it. When Myfortic is injected, the drug converts from mycophenolate mofetil (MMF) to mycophenolic acid (MPA). MPA has been shown to help prevent rejection of the new kidney by slowing down or suppressing the immune system, thereby providing additional time for the kidney to be accepted by the body.

Novartis mailed a ?dear doctor? letter to healthcare professionals in November 2007 informing of the increased risks of pregnancy loss and congenital malformations associated with use of Myfortic. The letter described new important safety information updates on the boxed warning, warnings, pregnancy precautions, and information for patient subsection precautions.

Women planning a pregnancy are warned by the FDA not to use Myfortic unless other organ rejection drugs can not be used. The FDA also asserts that female Myfortic patients in their childbearing years must receive contraceptive counseling and effective contraception while on the drug.

Sources: ?FDA Issues MedWatch on Novartis’ Myfortic,? FDA News, December 6, 2007; “Novartis’ Myfortic Poses Fetal Risks-FDA,” Reuters, November 27, 2007; ?Important Prescribing Information about Myfortic,? Novartis, November 2007.