FDA Strengthens Warnings on Acne Drug

Nov. 23, 2004 -- The FDA is strengthening its restrictions on the acne drug Accutane and its generic equivalents in an effort to reduce the risks of fetal exposure and birth defects associated with use of the drug by pregnant women.

The move is in response to the recommendations of an FDA advisory board earlier this year that urged tighter controls on the drug, which is known generically as isotretinoin.

In February, advisory board members said better monitoring is needed to track women of childbearing age to prevent them from becoming pregnant while taking the drug.

The drug was also in the news recently after a group of lawmakers called for a ban of the drug last month, and an FDA scientist named it as one of five potentially dangerous drugs on the market in congressional testimony last week.

Isotretinoin is used to treat severe acne that has not responded to other treatments. Prescribing information and the drug's label warn against use of the drug in pregnant women.

Under the new restrictions, manufacturers of Accutane and its generic versions will be required to keep track of not only doctors who prescribe the drug, but also the pharmacies that dispense the drug and the patients who use 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 doctor
• Proof of a recent negative pregnancy test before dispensing the drug
• Completed informed consent, education, and risk management information by the patient

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

The new risk minimization action plan (RiskMAP) for Accutane (isotretinoin) and its generic equivalents calls for the drug's manufacturers to:

• Establish and maintain the database
• Monitor sales of the drug outside the approved channels, such as on the Internet
• Develop procedures to monitor and evaluate RiskMAP compliance
• Evaluate the effectiveness of the program in reducing exposure to the drug during pregnancy