Roche Drug Cellcept Increases Risk of Birth Defects

Gary Shipman

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On Monday, the Food and Drug Administration said that Cellcept, a drug manufactured by drug giant Roche Holding AG and used for certain organ-transplant patients, was "associated with increased risk" of miscarriages and birth defects.

Both the FDA and Roche advised women of child-bearing age to insure that they have a negative pregnancy test before starting Cellcept, which is given to people who have received kidney, heart or liver transplants to help insure that the transplanted organs remain healthy. Transplanted organis can be rejected by the body, and Cellcept is designed to keep the body from attacking the new organ.

The medication already contains a "black box" warning, which is the FDA's strongest. Roche, in the face of these new findings, submitted a "Dear Doctor" letter to physicians, describing the new pregnancy warnings.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.