Accutane - Acne Drug: The Future of Accutane

by Food and Drug Administration (FDA)

(Page 3 of 3)

Roche does not want to have any Accutane-exposed pregnancies, a company spokesperson says, and plans to continue educational efforts. This year Roche launched a targeted Pregnancy Prevention Program that focuses on women who are at highest risk of becoming pregnant while taking Accutane.

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.

Monthly Accutane Prescriptions Ensure Follow-Up

Evelyn Germanakos of Los Angeles, Calif., recalls forgetting to have a blood test before returning to her dermatologist for a monthly visit while taking Accutane. "He sent me right away to get it and said he wouldn't renew the prescription without it," she says.

Experts say that kind of follow-up is critical. Doctors should only give one-month prescriptions for Accutane and should conduct urine or blood pregnancy testing and contraceptive counseling each month of treatment.

Monthly blood tests also allow doctors to monitor patients for other adverse effects. Elevated triglyceride levels, which can be associated with pancreatitis, have occurred in about 25 percent of patients in clinical trials for Accutane, and about 7 percent of patients showed an increase in cholesterol levels.

Alan N. Moshell, MD, director of the skin diseases branch at the National Institute of Arthritis and Musculoskeletal and Skin Diseases, says he's heard about severe adverse effects such as liver damage in cases where a full dose of Accutane has been prescribed with inadequate follow-up. "It has usually been a situation in which the full five-month course has been prescribed at the first visit and then the patient was not brought back, or simply failed to follow instructions about follow-up visits and blood tests." In such cases, patients may keep taking the drug and only return to the doctor when it's too late and they've experienced an adverse effect.

More common side effects of Accutane include lip inflammation and drying of the skin and mucous membranes. Germanakos says her mouth was incredibly dry. "I drank about 15 to 16 glasses of water a day, and I was still thirsty," she says. She also experienced skin peeling on her eyelids and dry nasal passages, and she says her acne got worse before it got better.

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.