WASHINGTON -- Accutane, an acne drug that a Food and Drug Administration whistle-blower said was too risky to be widely sold, has been shown to reduce adolescent depression.
A small study found that patients age 12 to 19 were less depressed four months after using Accutane than adolescents with moderate-to-severe acne who were prescribed antibiotics. The paper was one of three published about Accutane this month in a dermatology journal affiliated with the American Medical Association.
The finding comes as drug makers finalize new restrictions to better ensure that pregnant women do not use Accutane, which is known to cause birth defects. An FDA requirement to create registries of people who prescribe, use, and sell the drug prompted advisers to hold a meeting this month to consider whether Health Canada, the FDA's Canadian equivalent, needs to toughen its rules.
Nearly 85 percent of Americans age 12 to 24 suffer from acne. The onset of depression also commonly occurs about the same time. The study's authors funded and conducted the project to determine whether Accutane causes adolescents to become depressed and suicidal.
''For all of us that treat lots of kids with Accutane, we think that this drug is valuable and that its availability has certainly been threatened by a lot of anecdotal reports," said Dr. Elaine Siegfried. The St. Louis pediatric dermatologist was among five authors of the Archives of Dermatology report.
The authors found Accutane, a synthetic form of vitamin A manufactured by Hoffmann-La Roche Inc., alleviated depression, rather than worsened it.
But a drug safety expert worries that the study results could prompt some doctors to wrongly prescribe the drug to treat depression in young people.
''I think people could misconstrue that information and think, 'Well, the patient has a little acne. It's kind of mild. But they seem kind of depressed over it. So, I'll give them Accutane,' " said Dr. Peter A. Gross, chairman of the FDA's drug safety and risk management advisory committee. ''And that's exactly what we wouldn't want to happen."
US Representative Bart Stupak, who blames his teenage son's suicide on Accutane, said he viewed the study with a ''suspicious eye."
''Even Roche's own documents showed 1.5 times greater depression on Accutane than without," said the Michigan Democrat, who has pressed the FDA for more aggressive warnings.
Shelley Rosenstock, a Roche spokeswoman, said numerous studies show ''no increase in depression" among Accutane users.
The FDA's drug safety website notes that the agency ''continues to assess reports of suicide or suicide attempts" associated with the drug.
The study's design may limit its impact. The number of youths who participated, 132, is considered small. And at the four-month follow-up stage, the Accutane group was dominated by males, who Siegfried said tend to be less depressed than females the same age. The patients treated with antibiotics were dominated by females. Subjects and their parents helped to select which drug they would receive. Studies typically randomly assign patients to a treatment group. Such randomized studies often are done with industry funding, Siegfried said, raising suspicions about conclusions.
The expanded registry that begins in July was prompted by a finding contained in a second Archives of Dermatology paper written by FDA staffers. It said Hoffmann-La Roche has failed in attempts to prevent pregnant women from taking its drug. Yellow stickers affixed to prescriptions were intended to confirm that women taking Accutane were not pregnant. But 9 percent of prescriptions marked with the stickers were dispensed by pharmacies to sexually active women who did not get mandatory pregnancy tests before receiving the drug.
Enhanced safety steps now include a requirement that a woman with ''childbearing potential" has monthly pregnancy tests entered into a common database checked by doctors and pharmacies before she receives a 30-day supply of Accutane or its generic form, isotretinoin.
In testimony before Congress last fall, FDA whistle-blower David Graham included Accutane on a list of five drugs he said the FDA should restrict or ban. Graham's research linked Accutane to birth defects.
Siegfried said she doesn't ''object to some regulations for the drug" because of its potential to cause birth defects. ''But there's a fine line between being able to use the drug to its best advantage and making people frightened unnecessarily."
Diedtra Henderson can be reached at firstname.lastname@example.org.