HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Wednesday, August 24, 2005

New Regulations on ACNE Medication

Thanks to Dr. Douglas Mossmass for this excellent post:

Isotreninoin (brand name AccutaneTM) is an oral medication used for treating severe acne that does not respond to any other acne treatments, including antibiotics. Because of an extremely high risk of birth defects, women users of isotreninoin have for years been required to have two negative pregnancy tests and to commit themselves to using two simultaneous forms of birth control before starting to take the medication. Prescribers have had to participate in the "System to Manage Accutane Related Teratogenicity (S.M.A.R.T.TM). This program includes reading a booklet, signing a letter of understanding concerning the practitioner’s ability to diagnose acne and address risks associated with pregnancy, and affixing a yellow sticker to each prescription.

In addition to pregnancy-associated risks, isotretinoin may cause depression, psychosis, or suicidal ideation. The Food and Drug Administration (FDA) has been assessing reports of suicide or suicide attempts associated with use of this drug, and has recommended that all patients receiving isotretinoin be observed closely for symptoms of depression or suicidal thoughts.

On August 12, the FDA notified healthcare professionals and patients about a strengthened risk management program for isotretinoin called "iPLEDGE." iPLEDGE will require registration of wholesalers, prescribers, pharmacies and patients who agree to accept specific responsibilities for minimizing pregnancy exposures if they wish to distribute, prescribe, dispense, or use isotretinoin. The FDA also has approved changes to the existing warnings, patient information, and informed consent documentation so that patients and prescribers can better identify and address potential psychiatric problems before and after prescribing isotretinoin. The new patient information sheet appears here:

August 22 was the first date on which doctors, patients, and pharmacies could obtain information and register with iPLEDGE via the internet, at

After October 31, 2005, wholesalers and pharmacies will have to register with iPLEDGE to obtain isotretinoin from a manufacturer.

Starting December 31, 2005, all patients must be registered and activated by their doctors in iPLEDGE to get isotretinoin. Only prescriptions from iPLEDGE doctors will be filled by iPLEDGE pharmacies. Patients must sign the Patient Information/ Informed Consent form and must adhere to all the instructions in the iPLEDGE program. For women who can become pregnant, this includes using two effective birth control methods simultaneously and entering these methods of birth control each month into the iPLEDGE system by telephone or the internet. Women will also need to have negative pregnancy tests before each isotretinoin refill.


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