Until then, the FDA will see if it receives fewer reports of suicides or side effects now that this warning and consent program is in effect, says FDA spokeswoman Jonca Bull. The FDA is currently reviewing approximately 65 reports of suicides, and some 1,370 cases of psychiatric problems, among Accutane users since the drug first became available in 1982. On the informed consent document, patients must acknowledge they are aware of the potential mental health side effects and agree to tell their physician if they start experiencing them. They also must tell their doctor if they or any member of their family has had mental illness. The medication guide tells patients about Accutane's use and its potential side effects, including birth defects and mental disorders.
Doctors say the new policy is a responsible way to address the growing concerns.
Barbara Reed, a dermatologist in Denver, Colo., says she is aware of the anecdotal reports but in her practice has not seen significant evidence of the depression. She said she would stop prescribing the drug if a patient started getting depressed, but feels it is an effective treatment for severe acne. Indeed, Megan's college roommate had also taken Accutane and had no problems with it. She'd suffered from severe acne since her teenage years, but at 28 it became so bad, her face got puffy and she had fevers. Accutane and steroids helped.