A small study fails to link the use of the controversial acne drug Accutane to severe depression or suicide. The findings are reported in the May issue of the journal Archives of Dermatology.
For years, critics have said Accutane can cause serious depression and increase suicide in teens. A U.S. congressman blames the drug for his teenage son's suicide five years ago, as does a Florida mother whose 15-year-old son died in 2002 after intentionally flying a small plane into a Tampa, Fla., skyscraper.
But the drug's manufacturer has long contended that Accutane does not increase the risk of depression and suicide, and a newly published study appears to back that up.
Teens in the study who took the drug showed far fewer signs of depression three and four months after beginning treatment than they did before starting Accutane.
"This certainly backs up what we have seen in our practices," pediatric dermatologist Elaine Siegfried, MD, tells WebMD. "Most dermatologists are in agreement that Accutane is a miracle drug for acne. I have treated many thousands of patients with it, and I have never seen clinically significant mood alterations in any of my treated patients."
Accutane was approved in 1982 for the treatment of serious acne that doesn't respond to other treatment. Its safety has been the subject of heated debate ever since. A synthetic derivative of vitamin A, the drug is well known to cause serious birth defects in up to a third of babies born to women who use it during pregnancy.
As a result, women of childbearing years who take Accutane are required to use at least two forms of birth control while on the drug.
But while Accutane has long been suspected of causing depression, there is no direct proof to back up the claim, says psychiatrist Douglas G. Jacobs, who is a consultant to the drug's manufacturer, Roche Labs. Roche is a WebMD sponsor.
"I have spent more time reviewing the studies than anyone and there is just no evidence that Accutane causes depression or increases the risk of suicide," Jacobs tells WebMD.
A statement published earlier this month by the FDA notes that the agency continues to assess reports of suicide or suicidal attempts associated with the use of Accutane. The statement also calls on physicians to be vigilant about following their patients taking the drug closely for signs of depression.
The latest study was conducted by Siegfried and colleagues from St. Louis University Health Sciences Center without financial backing from Roche Pharmaceuticals.
The researchers used standardized tests to evaluate depression levels among teens with moderate to severe acne -- before beginning Accutane and while on the drug. Another group of teens who took antibiotics instead of Accutane for their acne were also evaluated.
Roughly 14 percent of the teens in the Accutane group and 19 percent of those in the antibiotic group had scores suggestive of depression before beginning treatment. Three to four months later about 8 percent of the teens taking Accutane and 15 percent of those taking antibiotics had similar scores.
Siegfried says it just makes sense that teens who feel better about the way they look will be less depressed.
"I have seen it over and over in my practice," she says.
Brain Imaging Studies
But Emory University psychiatrist J. Douglas Bremner, MD, who also studies Accutane, says the latest study was too small to answer many questions about whether Accutane causes depression. Of the 132 patients enrolled, 59 were treated with Accutane and 73 were prescribed antibiotics and topical creams.
Bremner says a study of at least 1,000 patients is needed to either prove or disprove the link between Accutane and depression.
The psychiatrist says his own recent imaging research shows that Accutane causes changes in the frontal lobe of the brain, which is associated with emotion. The research was published last month in the American Journal of Psychiatry.
Bremner found significant changes in the area of the brain known as the orbitofrontal cortex in 13 adults taking Accutane. No such changes were seen in a similar number of adults taking antibiotics.
But a Roche spokeswoman tells WebMD there is no consensus in the scientific community that the orbitofrontal cortex of the brain controls depression and mood. She added that there was no difference in depression symptoms between the people in Bremner's study taking Accutane and those taking antibiotics.
All the Evidence They Need
The lack of clinical proof has done nothing to change the views of those who blame Accutane for the suicide of a loved one.
Rep. Bart Stupak (D-Mich.) is among the drug's most outspoken critics. Stupak's 17-year-old son, B.J., shot himself in May of 2000, and Stupak says he believes Accutane is responsible. The legislator has been working to get tighter controls on Accutane ever since.
The mother of a teenager who killed himself by flying a Cessna airplane into a Florida high-rise office building in January 2002 is also convinced that Accutane caused her son's death.
And a grieving father in Ireland has reportedly spent more than $1 million of his own money attempting to prove that Accutane is linked to suicide. Liam Grant's 19-year-old son, also named Liam, took his own life in 1997 while studying engineering at Dublin University.
The elder Grant is now suing Roche and hopes to force the drug company to release confidential information about Accutane.
SOURCES: Chia, C. Archives of Dermatology, May 2005; vol 14: pp 557-560. Elaine Siegfried, MD, pediatric dermatologist, St. Louis. J. Douglas Bremner, MD, department of psychiatry, Emory University, Atlanta. Kathleen Quinn, spokeswoman, FDA. Shelley Rosenstock, executive director of public affairs, Hoffmann-La Roche.