A new study suggests Accutane, the controversial acne treatment that has been linked to suicide, can change brain functioning.
As a result, the authors of the study urged the Food and Drug Administration and the drug’s manufacturers, including Nutley- based Hoffmann-La Roche, to conduct further research into a medicine that is regularly prescribed to millions of Americans each year.
“The drug can cause symptoms of depression in a small percentage of people, so there should be screening for psychiatric disorders before going on the medication,” Douglas Bremner, the lead author and an Emory University psychiatry professor, said.
The study, which was published in the American Journal of Psychiatry, is the latest salvo in an ongoing debate over the safety of the drug. Approved in 1982, the drug has been blamed for Accutane birth defects and its usage is more closely monitored than other medicines.
The findings also come amid a heated controversy over the safety of prescription medicines. The issue erupted last fall after Merck withdrew Vioxx and concerns were raised over side effects caused by several antidepressants.
The latest study is the first to attempt to monitor brain functioning of Accutane patients and follows charges made last fall by an FDA medical reviewer that Accutane is one of five dangerous drugs that should not be on the market.
Concerns over Accutane and psychiatric side effects aren’t new, though.
Almost every Accutane lawsuit has charged the medicine causes suicide. Court documents in Florida revealed Roche’s internal estimates show the depression rate is 1.5 times higher among Accutane users, according to a published report last year.
Three years ago, the FDA issued new prescribing instructions for physicians and required Roche to update the drug warning label to reflect psychiatric side effects. To date, Accutane has been linked to 266 cases of suicide in the United States and overseas, according to the FDA.
Nonetheless, many doctors say teenagers with acne may suffer depression. A Roche spokeswoman, Shelley Rosenstock, yesterday repeated earlier arguments that no scientific evidence links Accutane to suicide. She also challenged the methodology of the new study.
An FDA spokeswoman, meanwhile, said the agency will continue to monitor information about Accutane, as well as three newer generic versions, and will review the study. However, critics say the FDA has not paid sufficient attention to suicide links.
“Without tighter distribution controls and further research into the cause of these potentially deadly side effects, the FDA cannot tell the American people it is adequately protecting their health and the health of their children,” said U.S. Rep. Bart Stupak (D-Mich.), whose son committed suicide while on the drug.
The new study scanned the brains of 28 healthy men and women whose median age was 26. Funding was provided mostly by an accountant in Ireland, whose teenage son committed suicide while taking Accutane several years ago, as well as several lawyers.