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Volume 359:991-994 September 4, 2008 Number 10
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Drug Warnings That Can Cause Fits — Communicating Risks in a Data-Poor Environment
Jerry Avorn, M.D.

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In 2005, after receiving case reports of suicides by patients taking anticonvulsant medications, the Food and Drug Administration (FDA) asked the manufacturers of 11 drugs in this class to report all suicide-related events in the controlled trials they had conducted over many years. This past January, nearly 3 years later, the agency completed its analysis of these data and announced that it had found a near-doubling of suicidal ideation and behavior among trial subjects randomly assigned to receive these drugs rather than placebo1 (odds ratio, 1.8; 95% confidence interval [CI], 1.2 to 2.72). For patients in epilepsy studies, the . . . [Full Text of this Article]


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Dr. Avorn is a professor of medicine at Harvard Medical School, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, and director of the Harvard Interfaculty Initiative on Medications and Society — all in Boston.




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