Infants born with congenital anomalies, such as microtia, an ear deformity, and cleft palate, may have gotten them due to exposure to mycophenolate mofetil (MMF). According to the FDA, MMF is the active drug in CellCept, manufactured by Roche Pharmaceuticals, and part of the chemical makeup of metabolite mycophenolic acid (MPA) in Myfortic, manufactured by Novartis Pharmaceuticals. Both CellCept and Myfortic are immunosuppressants. Links have also been made between MMF and MPA, and spontaneous abortion in the first trimester.
Expectant mothers were taking these drugs as part of their treatment following organ transplant, lupus, and erythema multiforme, a type of skin disorder caused by an allergic reaction. It has been noted that treatment for these conditions began before the women became pregnant, but continued into the first trimester.
Labeling of both MMF and MPA was revised in November 2007, showing the Pregnancy Category as “D.” This rating means that there is “positive evidence of human fetal risk, but potential benefits may warrant use of the drug in pregnant women despite the potential risk.” The FDA is currently working with the manufacturers of these drugs to reduce fetal exposure and lowering risks.
Notes for Women from the FDA
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If you are taking MMF or MPA early in your pregnancy, the risks of miscarriage or birth defects is increased
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If you are planning on getting pregnant, notify your doctor if you are already using CellCept or Myfortic so your doctor can change your medication
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If you are on MMF or MPA, you must use two effective forms of birth control (unless abstinence is your chosen method)
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Two forms of birth control should be used four weeks prior to beginning MMF or MPA and for six weeks after you have completed taking the medication
If you have a child born with birth defects or have miscarried, and you believe the cause was MMF or MPA, please contact an experienced injury lawyer in your area to see if you have a claim.
