FDA reissues warning on mycopheno drugs

The Food and Drug Administration has renewed warnings on immunosuppressants made by Swiss drug majors Roche and Novartis, after incidences of birth defects and miscarriages in organ transplant patients on the drugs.

The agency issued a similar warning late last year after it received reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil, the active drug substance in Roche's CellCept, which is an ester of the active metabolite of Novartis' Myfortic (mycophenolic acid).

In most cases, the mothers were taking MMF following an organ transplant to prevent organ rejection, it noted. However, some mothers taking MMF were being treated for immune-mediated conditions such as systemic lupus erythematosus and erythema multiforme. Treatment began before their pregnancies and continued into the first trimester or until the pregnancy was detected. While the FDA has received no new reports of side effects, it reissued the warning on fears that some doctors may have missed it the first time round.