FDA Approves Plan for Organ-Transplant Drugs to Warn of Birth Defects

The U.S. Food and Drug Administration approved a risk-mitigation plan for a specific class of organ-transplant drugs to warn women about the risk of miscarriages and birth defects. The plan is aimed at drugs containing the active ingredient mycophenolate. The drugs, which include Roche’s CellCept and Novartis’ Myfortic, are used in combination with other medicines to help prevent the body from rejecting a transplanted organ.
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