Experts agree that pregnancy prevention education should remain a key part of risk management for Accutane use. But more labeling changes and letters are not likely to make a significant difference, according to FDA's Honig. "During all the time the drug has been on the market and after all of those labeling changes, there are still pregnancies," he says. "It is not expected that another labeling change or 'Dear Doctor' letter will change behavior at this point." Psychiatric adverse events have also continued after labeling changes.
FDA's Dermatologic and Ophthalmic Drugs Advisory Committee met in September 2000 to discuss options for Accutane, and to evaluate whether a framework for safer use of the drug can be developed. One change since then is that all Accutane prescriptions now come with a new Medication Guide that contains warnings about pregnancy and psychiatric issues, plus other important warnings and precautions regarding potentially serious or life-threatening effects.
FDA has also proposed a mandatory registration of patients taking Accutane, prescribers, and pharmacists. "The main reason is to ensure that pregnancy testing is done before the drug is prescribed," says Julie Beitz, MD, of FDA's office of postmarketing drug risk assessment. The goal would be to have doctors document negative pregnancy tests and to have pharmacies dispense the drug only to women who have had negative pregnancy tests. The program to track Accutane patients is expected to be in place by summer 2001.
The registry for prescribers may involve a continuing education course that doctors would have to take to be able to prescribe Accutane. According to Hoffmann-La Roche, about 85 percent of Accutane prescriptions come from dermatologists and 15 percent come from primary care physicians. The course would be open to all medical doctors. And all Accutane patients would have to sign a mandatory consent form that would address both pregnancy and psychiatric issues, Beitz says.
The American Academy of Dermatology and the Dermatologic Nurses Association were among those who testified at the September 2000 committee meeting in opposition to a mandatory registration, saying that it would be a disservice to patients, making it harder for them to obtain the drug. Others, including the March of Dimes and the Public Citizen's Health Research Group, testified that they want to see stricter measures for Accutane.
FDA's experts say it's a balancing act. The value of Accutane is clear, but when it comes to even one report of death--whether it's suicide, miscarriage, or some other cause--FDA must make choices that will best protect the public's health.
Michelle Meadows
U.S. Food and Drug Administration
FDA Consumer magazine
March-April 2001
