Study Finds Acne Drug Can Affect
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, Accutane has been blamed for 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. A growing number of lawsuits have charged the medicine
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.