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. 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.
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. 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.