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The Food and Drug Administration has fully implemented a new program to ensure that the acne drug isotretinoin (Accutane) is not used by pregnant women or those who can become pregnant.
The Food and Drug Administration has fully implemented a new program to ensure that the acne drug isotretinoin (Accutane) is not used by pregnant women or those who can become pregnant. Isotretinoin is an effective treatment of severe recalcitrant nodular acne, but has been known to cause birth defects when pregnant women are exposed to the drug. It has also been associated with severe depression.
The new rules require women of child-bearing age to take a pregnancy test every month. These tests must be negative before a new prescription for isotretinoin can be written, reported The Wall Street Journal (2/23/06). Women who take the drug must also commit to using two forms of effective contraception simultaneously 1 month before, during, and 1 month after treatment with isotretinoin. Prescribers would then document their contraceptive counseling with the patients, the list of contraception to be used by the patient, and the results of the pregnancy test in the FDA's program, known as iPledge.
As of March 1, the drug is only available through the iPledge program. Information on the program can be found by calling the iPledge call center at 1-866-495-0654 (8 AM to midnight EST, Monday through Saturday) or going online at http://www.ipledgeprogram.com/.