The FDA is warning doctors again that organ-transplant drugs CellCept (from Roche) and Myfortic (Novartis) have been linked to miscarriages and birth defects when taken by pregnant women. Last October, the agency announced that it had received reports of these side effects, and at the time added warnings to the two drugs' labels. The new round of FDA alerts doesn't stem from additional reports of safety problems, but from the agency's fear that physicians didn't get the initial heads-up. Before prescribing the drugs, the agency says, doctors should confirm that their transplant patients are not pregnant, and should make sure that the patients are using effective contraception.
Patient who'd experienced miscarriages and birth defects were mostly mothers who took CellCept before their pregnancies were detected. Some were taking the med not because they'd received organ transplants, but to treat rheumatoid arthritis and lupus--both off-label uses for the drug.
The new warning comes just a month after another CellCept alert: FDA announced in April that it was investigating 16 patients who'd developed a rare neurological disease while taking it.