FDA plans for increased monitoring of Accutane

Journal of Drugs in Dermatology, Jan-Feb, 2005

The U.S. Food and Drug Administration is strengthening required monitoring of isotretinoin (Accutane[R]) in further efforts to reduce the risks of fetal exposure and birth defects associated with women who become pregnant while taking the drug. The initiative is in response to recommendations of an FDA advisory board earlier this year that urged tighter controls on the drug. Accutane has come under fire by a group of lawmakers who had previously called for a ban of the drug.

Isotretinoin is used to treat severe acne that is recalcitrant to other treatments. Prescribing information and the drug's label warn against use of the drug in pregnant women. Under the new risk minimization action plan (RiskMAP) for isotretinoin, manufacturers of isotretinoin will be required to monitor not only physicians prescribing the drug, but also pharmacies dispensing the drug and patients using it. In addition to registering in a central database, the regulations require verification of the following before a patient's first prescription is filled:

* Completion of patient education on the potential risks of the drug by the prescribing physician.

* Proof of a recent negative pregnancy test before dispensing the drug.

* Completed informed consent, education, and risk management information.

For subsequent refills, verification of monthly patient education, repeat negative pregnancy tests, and ongoing risk management will also be required.