New Warnings With Accutane Use
N E W Y O R K, Jan. 29 -- Megan McKinley, 19, had been an honors student until she took Accutane, the popular acne drug.
The Norfolk, Va.-teen entered college early on a community service scholarship, participated in community theater and won awards. She was “a very happy kid,” says her mother Karen. But she did have very bad acne, so on the advice of her doctor, she began taking Accutane, the only drug available to treat serious acne, a scourge common to young adults.
Once on Accutane, she began experiencing fatigue and memory loss, and her mother, a psychotherapist, asked the doctor if her symptoms might be connected to the drug. The doctor said the drug and her feelings were unrelated.
Megan improved after she stopped taking Accutane, but when placed back on it for another course of treatment, she had a “big meltdown,” and never quite recovered. Today, the young woman often spends days crying, cannot concentrate and cannot attend classes at school. She is finishing her education at home.
New Accutane Warnings
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.
On Thursday, Roche sent dermatologists, family physicians, psychiatrists and pharmacists material informing them that patients who agree to take Accutane must get a medication guide and sign what is called an “informed consent.”
Both address mental disorder side effects, saying “Some patients while taking Accutane or soon after stopping Accutane have become depressed or developed other serious mental problems.”
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.
Related Stories
ABC News Live