Acne Drug Gets Powerful Restrictions

September 2006

Isotretinoin, more commonly known as Accutane, is getting harder and harder to come by after the government enforced strict rules to hopefully eliminate the drug’s dangerous side effects. The Food and Drug Administration (FDA) started a program known as iPledge, and requires all users of the drug to follow the rules in order to obtain Accutane.

Features of the iPledge program include:

• All patients, physicians, pharmacists and drug distributors must register with iPledge.
• Women of child-bearing age must take a pregnancy test and be on at least two forms of birth control for 30 days. To receive a prescription, they must take a blood pregnancy test within five days of their periods.
• Every month, women must visit their dermatologist, take a blood pregnancy test, and log on to the iPledge site to answer questions and to confirm they are on two forms of birth control. Doctors are responsible for updating the patient’s birth control information.
• If answers from doctors and patients do not match, the iPledge system will deny access to the monthly prescription. Women must also log on to the system every month or they will not be able to get their monthly prescription.
• Men must also visit their doctor each month to receive a monthly prescription.
• Patients only have seven days, including weekends and holidays, to fill their prescription.
• If a pregnancy test is positive, a woman would not receive a refill.

Generic versions of the drug include:

• Amnesteem from Mylan Laboratories
• Claravis from Barr Pharmaceuticals
• Sotret from Ranbaxy Laboratories

The FDA feels that these steps are necessary due to the potency of Isotretinoin. The drug has been linked to birth defects including disfigured heads, missing ears and heart defects.

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