The FDA issue a warning to healthcare professionals on Monday about elevated risks of birth defects associated with the drug CellCept. The drug is used as anti-rejection aid for patients that have received transplants. The FDA warns of concerns of an increased likelihood of miscarriage in the first trimester of pregnancy and the risk of severe birth defects during fetal development. The FDA has also warned that CellCept may cause oral contraceptives to be less effective or ineffective in some situations.
Women of childbearing potential should have a negative pregnancy test within a week of starting the immune-system suppressing drug, and must receive birth control counseling and use effective contraception, the FDA said.
The new boxed is accompanied by a category change for the drug regarding its potential risk to the fetus. CellCept is no longer categorized under Category C meaning “risk of fetal harm cannot be ruled out,” but rather the Category D reserved for drugs that have shown “positive evidence of fetal risk.” The drug’s maker, Roche estimates that almost 460,000 have been exposed to the drug since its approval in 1995.
Switzerland’s Roche Holding said it is difficult to estimate how often the problems have occurred, the company cited 25 miscarriages among 77 women exposed to the drug between 1995 and 2007. Fourteen of the women exposed to the drug had deformed babies or fetuses, according to a national registry that tracks women who undergo organ transplant.
For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.