Accutane Safety Program Improved Before Start Date

Yael Waknine

February 24, 2006

Feb. 24, 2006 -- The US Food and Drug Administration (FDA) released a statement yesterday advising healthcare professionals that iPledge, the risk management program for isotretinoin ( Accutane), will be implemented as expected on March 1, 2006.

The mandatory program is intended to reduce the risk for fetal exposure to the teratogenic drug by tightly linking negative pregnancy testing with isotretinoin distribution. It was originally scheduled to debut on November 1, 2005.

As of March 1, each monthly prescription of isotretinoin will only be dispensed if the criteria for the prescriber, patient, and pharmacy have been met, thereby ensuring that the drug is not prescribed for pregnant women and that pregnancy does not occur during treatment.

According to the FDA, a large number of prescribers, wholesalers, and pharmacies have registered in the program in anticipation of the start date, and more than 1200 patients per day have registered during the past few weeks.

The agency has worked closely with isotretinoin sponsors and their vendor (Covance, Inc) to address concerns recently raised by dermatologists and pharmacists regarding the operational aspects of the program.

Specific measures implemented to ensure access to and safe use of the drug include increased staffing at the iPledge program's call center to handle increases in call volume and user questions during the next few weeks, and an enhanced system to process requests for lost or forgotten user passwords.

Physicians participating in the program are reminded that they will be required to input information (including pregnancy test results) into the system on a monthly basis for female patients of childbearing age. An interactive component for patients will ensure that women are aware of the need to use 2 separate, effective forms of contraception at least 1 month before, during, and for 1 month after therapy to ensure drug clearance from the body.

In addition, all patients are restricted from donating blood until 1 month has elapsed since discontinuation of isotretinoin therapy.

Because treatment with isotretinoin also carries a risk for psychiatric effects, all patients should be observed closely for depression or suicidal thinking. In addition to discontinuation of therapy, further psychiatric evaluation and treatment may be necessary to prevent self-harm.

Accutane is marketed in the United States by Hoffman-LaRoche Inc and is also available generically as Amnesteem (made by Genpharm Inc), Claravis (made by Barr Laboratories Inc), and Sotret (made by Ranbaxy Pharmaceuticals Inc).

Additional information regarding iPledge may be obtained online at http://www.ipledgeprogram.com or by contacting the program's call center at 1-866-495-0654.

Healthcare professionals are encouraged to report isotretinoin-related adverse to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch , or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

Reviewed by Gary D. Vogin, MD

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