Managing Acne-Drug Risk in Pregnancy

A new program is designed to minimize fetal exposure to isotretinoin, which has a high risk of causing birth defects when taken during pregnancy.

Isotretinoin, marketed under the brand names Accutane, Amnesteem, Claravis, and Sotret, is used to treat recalcitrant nodular acne that has not responded to other therapies. The new risk-management program called iPledge, is to be implemented in stages over the next several months through a restricted U.S. distribution policy approved by the U.S. Food and Drug Administration (FDA, Washington, DC, USA). It is designed to ensure that no woman begins isotretinoin therapy if she is pregnant and that no woman taking isotretinoin becomes pregnant during treatment.

The iPledge program requires mandatory registration of prescribers, patients, wholesalers, and pharmacies. It also requires laboratory-certified monthly pregnancy tests for female patients to confirm pregnancy status before they receive isotretinoin treatment. The iPledge program will grant dispensing authorization to a pharmacy only if all criteria for the patient, prescriber, and pharmacy have been met. Part of the system is a requirement for patients to use two forms of effective contraception simultaneously for one month before and during treatment and for one month after treatment.

Isotretinoin can only be dispensed in the United States by prescribers who are registered and activated with the iPledge program and can be dispensed only to patients who are registered and meet all the requirements of the program. The program was developed by isotretinoin manufacturers along with Covance (Princeton, NJ, USA), a drug development services company, in collaboration with the FDA.





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FDA
Covance