New Warnings With Accutane Use
N E W Y O R K, Jan. 29, 2001 -- 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.
Despite the new warnings, Roche maintains there is no scientific evidence of a link between Accutane and depression or suicide. A Roche spokesperson says there is a “high incidence of depression and suicide among boys who may not go to a doctor.” These new consent forms are making “parents and physicians pay more attention to such problems.”
Studies Necessary To Show Link
FDA, Roche and the National Institutes of Health are in discussions to develop an appropriate scientific study to determine if there is a “relationship between use of Accutane and any psychiatric issues,” according to the Roche spokesperson.
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.
Informed Consent Lists Possible Psychiatric Problems
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.
“I will tell my patients that in my practice with hundreds of patients I have known very few to be depressed, but they need to tell me if they feel very sad while taking this medication,” explains Reed. 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.
Likewise, Kim Williams, 31, of Lake Orion, Mich., benefited from the drug. 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. Williams says she she would have "given a limb" for clear skin and still would have taken the drug even with a consent form. She hopes the drug stays on the market, and worries that if she has kids one day, they won’t have anything available to them if they suffer as she did.
Earlier Accutane Warnings
The new warnings are not the first connected to Accutane. Accutane’s package insert noted links to depression since 1986 and to suicide since May. Women who took it had to agree not to get pregnant while on it because the drug can cause birth defects.
Because women still have been getting pregnant while on the drug, Roche is now also requiring that woman take two pregnancy tests before beginning treatment.
Megan’s mother says her doctor did not advise her or her daughter of the possible depression side effects that the earlier package insert had warned about. Megan says the new detailed consent form would have made her aware of the dangers of the drug, but she feels it shouldn’t be available at all.
Others also feel they were not properly counseled about the Accutane. The parents of Joshua Simonetti, of Medford, Ore., a 15-year-old teenager who committed suicide while taking Accutane, are suing the dermatologist and Roche, claiming the drug contributed to their son’s death and the company and doctor did not adequately warn them of its potential risks.
Lawsuit: Family Wasn't Warned
Renee Lee, of Albertville, Minn., the mother of a 15-year-old who attempted suicide while on Accutane, thinks the consent forms will likely deter people from taking Accutane and feels that is a good thing. Young adults, who are at a very sensitive point in their lives, should not risk taking the drug at all, Lee says.
The House Reform Committee held hearings last month at which patients described suicide attempts and depression that they believed were due to Accutane. In October, Rep. Bart Stupak, (D-Mich.) whose 17-year-old son killed himself while taking Accutane, called for more studies to determine whether the drug can cause suicidal thoughts. An FDA advisory committee also met in September to address the mental health and pregnancy issues.
“Although it is difficult to make a reasonable linkage [between suicide and the drug], the agency is compelled to do something because the outcome … is so serious,” FDA’s Bull says. “It seemed prudent to inform patients and prescribers if one suicide could be prevented, if someone became aware of the risk.”
Accutane was a nightmare for Megan. She has been on 14 different types of antidepressants during the whole ordeal. “Teenagers will do anything to have clear skin but I’ve lost almost two years of my life because of this drug,” says Megan, who wants the drug off the market. “It’s not worth it. I don’t even have clear skin now.”
ABCNEWS.com's Ephrat Livni and The Associated Press Contributed to this report.