Resources for Food and Drug Administration (FDA)

FDA Issues Second CellCept Warning

www.newsinferno.com

The Food and Drug Administration (FDA) issued another warning Friday that Roche and Novartis drugs prescribed to organ transplant patients can cause miscarriages and birth defects when taken by pregnant women. Birth defects include external ear and facial abnormalities such as cleft palate and lip as well as problems with the distal limbs, esophagus, and kidney. This recent warning was the second in less than two months.

Last October, Roche’s CellCept and Myforic by Novartis labeling were updated to include a boxed warning over the potential for miscarriages and birth defects. The new CellCept labeling classified the risk as Category D (Positive Evidence of Fetal Risk). The concern about side effects was so great that the FDA warned women of childbearing age to use two methods of birth control before, during, and after CellCept treatment.

FDA spokesman Christopher Kelly said it has not received new reports of pregnancy-related problems; however, the FDA reissued the warning over concerns some doctors may not have seen the initial warning. Roche previously reported 25 miscarriages among 77 women exposed to the drug between 1995 and 2007. In a notice posted online Friday, the FDA said that before prescribing the drugs doctors should confirm their transplant patients are not pregnant and are using effective contraception.

View the Resource

Share or bookmarklet this web page at: