Stronger Risk Management Program for Accutane (isotretinoin)

Revised October 28, 2005: The implementation dates of the iPLEDGE program have been revised. The date by which wholesalers and pharmacies must be registered /activated in IPLEDGE has been changed from November 1, 2005 to December 30, 2005. By March 1, 2006, only prescribers registered and activated in iPLEDGE can prescribe isotretinoin and only patients registered and qualified in iPLEDGE can be dispensed isotretinoin. Patients can begin registering and qualifying on December 30, 2005.

FDA has developed stronger requirements to prevent fetal exposure to the drug Accutane (isotretinoin) along with its generic equivalents, such as Amnesteem, Sotret and Claravis. Isotretinoin is used to treat severe, recalcitrant, nodular acne, but it can cause serious birth defects if taken by pregnant women.

These requirements are now going into effect in a new program called iPLEDGE. Under this program, wholesalers, prescribers, pharmacies and patients, both men and women, must register. Also, women who are capable of becoming pregnant must have two negative pregnancy tests before isotretinoin can be dispensed to them. They also must have a negative pregnancy test each month while taking the drug.

Isotretinoin is now a restricted distribution drug. This means that wholesalers won't be able to distribute the drug, pharmacists won't be able to dispense it, physicians won't be able to prescribe it, and patients won't be able to receive it unless they register. Doctors, patients, and pharmacies can obtain program information and register with iPLEDGE either online or by telephone at 1-866-495-0654.

There is also a possible link between taking this drug and depression, suicidality, and psychosis. And for that reason, FDA has strengthened the labeling to help practitioners and patients identify and manage these risks.

Any patient being treated with this drug should be carefully monitored for symptoms of depression, or suicidalility or psychosis. Patients should be told to stop the drug and contact their health professional if they experience any of these symptoms. Stopping the drug by itself, however, may not be sufficient. Psychiatric evaluation and intervention may be needed to prevent patients from harming themselves.

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News & Politics

Tags:

• Stronger
• Risk
• Management
• Program
• Accutane
• (isotretinoin)
• iPLEDGE
• Wholesale
• Pharmacy
• FDA
• Amnesteem
• Sotret
• Claravis
• Acne