The drug, which is take by approximately 500,000 Americans each year, is essentially the only treatment for severe or nodular acne, which patients colloquially call “pizza face.” The condition affects mainly young men but also women in the 20s, 30s and 40s. Sufferers often experience scarring.

Because the Food and Drug Administration began receiving an increasing number of anecdotal reports of psychiatric problems associated with Accutane’s usage, the agency has pressured the drug’s manufacturer, Roche Pharmaceuticals, of Nutley, N.J to change how it is prescribed.

New Patient Warnings

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.”

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.”

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.

Anecdotal Reports of Suicide on Drug

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.

Bull says the number of reports it receives for adverse reactions from any drug are usually about 1 percent to 10 percent of the true total, since reporting of adverse events is voluntary. “As there is greater marketing of a drug, there is increased knowledge of its risk profile,” Bull says. The agency continues to change how manufacturers label drugs, she says.

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.

Other Accutane Restrictions

This is not the first restriction associated with Accutane’s use. 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.

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.”