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.


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.


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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