Research Day (http://www.researchresearch.com)

USA Congress 01 October 2004

Congressman calls for renewed research into psychiatric effects of Accutane

Michigan Democrat Rep. Bart Stupak is making a renewed call for research on Accutane-a prescription drug by Hoffman-LaRoche used to treat severe cystic acne that is unresponsive to conventional treatments like antibiotics.

On September 29, the congressman stated that not enough is known about the psychiatric effects associated with the drug, which include depression, suicidal thoughts and behavior, as well as aggression.

The drug, approved by the Food and Drug Administration in 1982, is prescribed to some 1.5 million young people nationwide every year. In his floor remarks, Stupak shared the results of Emory University researcher J.D. Bremner, which found significant changes in the orbitofrontal cortex of the brain, an area known to mediate symptoms of depression, in those taking the drug.

"These [brain] scans show the promise of more research, and Hoffman-LaRoche has always denied that Accutane affects the brain," he stated. "I do not know why the FDA and Hoffman-LaRoche seem reluctant to look for these answers. The FDA has already determined that the link between Accutane and psychiatric events is strong enough to require a bold warning on the physician label and the packaging label for this drug."

Stupak concluded with a call for a renewed examination of Accutane by the FDA, stating that the agency should re-examine previous studies and associated advisory committee recommendations submitted on the drug. "There is no excuse for allowing Accutane to be prescribed to hundreds of thousands of kids without, at the very least, continuing to demand answers as to the effect of this drug on the brain," he asserted. "History suggests that unless there is strong leadership from Congress on this issue, advisory recommendations to the FDA will end up collecting dust on a shelf."