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 Myfortic in Pregnancy
The pregnancy category for mycophenolic acid (Myfortic) has been changed to D (positive evidence of fetal risk), and the drug label will soon carry a new boxed warning for women of childbearing potential.
Postmarketing studies have shown that the drug increases the risk of pregnancy loss in the first trimester. It also increases the risk of congenital malformations, especially abnormalities of the ear, face (such as cleft lip and palate), distal limbs, heart, esophagus, and kidneys. The drug maker urges health care providers to do the following:
- Tell any woman of childbearing potential about these risks.
- Make sure the patient has a negative pregnancy test with a sensitivity of at least 25 mIU/ml 1 week before therapy starts.
- Require that the patient have contraceptive counseling and use two types of effective contraception during Myfortic therapy.
- Instruct her to continue using contraception for 6 weeks after Myfortic therapy stops.
Tell any woman planning pregnancy not to take Myfortic unless no other immunosuppressant is effective.
Mycophenolic acid is used to prevent organ rejection in patients undergoing allogenic renal transplant. Therapy also includes cyclosporine and corticosteroids and should be managed by experienced health care providers in appropriately equipped facilities.
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