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FDA warning on immune system drugs

The US Food and Drug Administration has issued a warning that CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid) have been linked to first-trimester miscarriages and birth defects.

CellCept and Myfortic are immunosuppressive medicines used to prevent organ transplant rejection.

CellCept is prescribed to treat conditions resulting from abnormal activity in the immune system, such as systemic lupus erythematosus (SLE), rheumatoid arthritis or erythema multiforme. However, CellCept is not approved for use in treating those conditions in the US, the FDA said.

The FDA recommends a number of strategies to assist healthcare professionals in reducing pregnancy-related risks associated with these products.

These include confirming that a pregnancy has not occurred and ensuring that patients use effective contraceptive measures. Women taking CellCept and Myfortic and who are planning to become pregnant should also consult with their doctors about the risks involved and to find out if alternative immunosuppressive agents can be used.

The FDA revised the labelling for both CellCept and Myfortic in November 2007. Information concerning the risk of spontaneous abortion and birth defects was added.

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