Today, the young woman often spends days crying, cannot concentrate and cannot attend classes at school. She is finishing her education at home. It was anecdotal reports linking psychiatric problems like Megan's with Accutane use that prompted the Food and Drug Administration to pressure the drug's manufacturer, Roche Pharmaceuticals, of Nutley, N.J., to issue new warning labels about how it is prescribed. The drug, which is taken by approximately 500,000 Americans each year, is essentially the only treatment for severe or nodular acne. The condition affects mainly young men but also women in the 20s, 30s and 40s.
Sufferers often experience scarring.
While many people do not experience the mood changes on the medication, enough cases of psychiatric reactions drew the FDA's attention. Despite the new warnings, Roche maintains there is no scientific evidence of a link between Accutane and depression or suicide. 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.