DOCTOR'S VIEW ARCHIVE
FDA Knew Antidepressant Danger to Kids
Medical Authors and Editors:
Barbara K. Hecht,
Ph.D. and
Frederick Hecht, M.D.
Aug 20, 2004 -- Last year a senior US government
scientist concluded that most antidepressants are too dangerous for children
because they greatly increase the risk of suicide but his superiors at the FDA disagreed with his
findings and kept his recommendations secret, according to a report in The New
York Times today.
The scientist, Dr. Andrew D. Mosholder, a senior
epidemiologist at the FDA who
assesses the safety of medicines, found last year that 22 studies showed that
children given antidepressants were nearly twice as likely to become suicidal as
those given placebos. But Mosholder's superiors disputed his findings and sought
a new analysis.
The New Analysis
The findings of the new analysis match Dr. Mosholder's conclusions although
the two studies used different methods and different numbers, Dr. Mosholder
wrote in an internal memo a copy of which was made available to The New York
Times.
In fact, the new analysis revealed that the antidepressants Paxil and Effexor
have been found even more likely to cause suicidal behavior in children, his
memo said, than his original analysis a year ago.
Perspective
This information is likely to
refuel the debate about whether the FDA should forbid the prescription of
antidepressants to children. In 2003 the British government banned the use of
all antidepressants, except Prozac, for children.
Last year Dr. Mosholder also recommended that the FDA
ban the prescription of all antidepressants to children with the exception of
Prozac, the only pill that has proven beneficial in treating childhood
depression.
Comment
We think the FDA has some explaining to do. It needs to explain why it
suppressed Dr. Mosholder's findings and recommendations last year. We hope that
Senator Charles Grassley (Rep-Iowa) who has been pushing an investigation into
the FDA handling of this matter will keep pushing.
The mission statement of the FDA states that: "The FDA
is responsible for protecting the public health by assuring the safety,
efficacy, and security of human and veterinary drugs, biological products,
medical devices, our nation's food supply, cosmetics, and products that emit
radiation."
In keeping with its mission statement, the FDA needs to act now to ban all
antidepressants except Prozac for children before the lives of more children in
the US are put in jeopardy.
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Last Editorial Review: 8/20/2004
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