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January 25, 2008
New FDA rules may require drugmakers to assess suicide risk during drug trials
On its front page, the New York Times (1/24, A1, Harris) reports that according to "new rules represent[ing] one of the most profound changes of the past 16 years to regulations governing drug development," the U.S. Food and Drug Administration (FDA) is now requiring pharmaceutical companies to "put a comprehensive suicide assessment into their clinical trials."
The new requirements come as "agency officials realized that multiple classes of medicines might cause dangerous psychiatric problems." The FDA's action was also spurred by findings that medications used "to treat acne, hypertension, high cholesterol, swelling, heartburn, pain, bacterial infections, and insomnia, can all cause psychiatric problems, effects that were discovered in most cases after the drugs were approved and used in millions of patients."
Although the agency "has determined that [many] drugs' benefits outweigh their psychiatric risks," the FDA "now wants to uncover such problems more reliably, and before approval." Kelly L. Posner, Ph.D., of Columbia University, and colleagues, "developed a questionnaire to help systematically assess suicidal thoughts and behavior." The FDA now requires that drugmakers "adopt th[is] methodology in their clinical trials."
Related Links:
- "F.D.A. Requiring Suicide Studies in Drug Trials," Gardiner Harris, New York Times, January 24, 2008.
- U.S. Food and Drug Administration
Posted by admin at January 25, 2008 02:46 PM