Foetal risk observed in anti-rejection drugs

Novartis and the FDA have informed healthcare professionals and patients that use of Myfortic Delayed-Release Tablets (mycophenolate) during pregnancy increases the risk of miscarriage and congenital malformations.

Myfortic is used in preventing organ rejection following kidney, liver or heart transplants, and is generally used in combination with cyclosporine and corticosteroids.

In the US, Myfortic has been categorised in class D, which means there is positive evidence of foetal risk. According to the FDA, post-marketing data collected by the US National Transplantation Pregnancy Registry indicated that the active ingredient mycophenolate mofetil (MMF) puts pregnant women at a high risk of miscarriage and having babies with birth defects.

Both the FDA and Novartis advise that any woman who is pregnant or plans to get pregnant should not use this medication, unless there is no other alternative for treatment. Novartis said in a letter to healthcare providers that the drug would carry a new safety warning stressing the increased miscarriage risk and malformations of the external ear and the face, such as cleft lip and palate.

Roche's CellCept also flagged
In other news, the FDA also warned that Swiss pharmaceutical company Roche's own organ rejection drug CellCept (mycophenolate mofetil) raises the risk of miscarriage in the first trimester and can cause congenital malformations.

CellCept is the top selling immunosuppressant in the US. Global sales in the nine months to September 30 2007 were CHF 1.2bn (USD 1.1bn).