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FDA Sat on Report Linking Suicide, Drugs

Officials ordered more studies after their own expert found children on antidepressants were twice as likely to show suicidal behavior.

The Nation

April 06, 2004|Elizabeth Shogren, Times Staff Writer

During the panel session, FDA officials explained that the Columbia University experts would analyze the data from the drug company trials, and their results would be published this summer.

One of the reasons that some senators and representatives decided to investigate the FDA's approach to regulating antidepressants was that the British government -- faced with the same information -- took a much more protective action, warning doctors not to prescribe any of the drugs to children except Prozac, or fluoxetine, according to congressional staffers.


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Mosholder wrote that his conclusion "essentially mirrors the conclusions" of the Medicines and Healthcare products Regulatory Agency, the FDA's British counterpart.

Glenmullen said that given Mosholder's findings, the FDA should have given a stronger warning to Americans about the possible risks of using the drugs.

"For the FDA to issue an ambiguous warning when they had unambiguous data like this is an outrage," Glenmullen said.

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