Health regulators have warned for the second time about transplant drugs from Roche and Novartis that can cause miscarriage and birth defects if used during pregnancy.
The US Food and Drug Administration (FDA) said it had received reports of miscarriages, and of ear and mouth defects in newborns whose mothers took Roche's CellCept (mycophenolate mofetil), and added its strongest warning to CellCept and to the similar Novartis drug Myfortic (mycophenolic acid). Both drugs suppress the immune system to stop the body rejecting a transplanted organ.
The FDA stresses that before treatment, doctors should make sure the woman isn't pregnant and is using effective contraception. Most reports came from women who took CellCept before finding out they were pregnant, and some were taking it for unapproved uses, such as rheumatoid arthritis and lupus.
A Roche spokesperson said there had been no new reports since the label was updated; between 1995 and 2007 the company received reports of 25 miscarriages among 77 women who took the drug. The FDA said it would work with Roche and Novartis to reduce use of the drugs in pregnancy.
This was the FDA's second warning about CellCept in less than two months. The previous month it reported 16 patients taking the drug who developed progressive multifocal leukoencephalopathy (PML), a rare brain infection that is often fatal; symptoms include problems with vision, memory and balance.
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