FDA Adds New Warning to Cellcept Drug

Jamie Sheller

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Earlier this week, the FDA, along with Roche, the maker of Cellcept, notified healthcare providers that use of Cellcept is associated with pregnancy loss, and increased risk of congenital malfunctions. Specific abnormalities include cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney. Cellcept is typically given to kidney, heart or liver transplant recipients to suppress organ rejection. The drug also helps keep the new organ healthy. Due to the severity of the adverse events, the FDA has required Roche to change its warning from a Category C (Risk of Fetal Harm Cannot be Ruled Out) to Category D (Positive Evidence of Fetal Risk). Roche recommends that doctors give women of childbearing years a pregnancy test prior to prescribing the medication, as well as advise women to use two forms of birth control to prevent pregnancy during the use of the drug.

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