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Suicide Risk Now Included In FDA's New Drug Trials

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By GARDINER HARRIS, The New York Times

Published: January 24, 2008

After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration is now requiring drug makers to study closely whether patients become suicidal during clinical trials.

The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But because the FDA's oversight of experimental medicines is done in secret, the agency's shift has not been announced publicly.

The drug industry, however, is keenly aware of the change.

Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the drug agency to put a comprehensive suicide assessment into their clinical trials.

In recent months, the agency has sent letters - it would not say how many - to drug makers requiring that they use such a scale. Merck, Sanofi-Aventis and Eli Lilly are all using a detailed suicide assessment in clinical trials being conducted now.

The seeds for the new federal effort were planted four years ago with the discovery that antidepressants may cause some children and teenagers to become suicidal.

Top agency officials at first discounted the finding but commissioned researchers from Columbia University's department of psychiatry, led by Kelly Posner, to reanalyze the drugs' clinical trials. This work caused the agency and its experts to view the risk as real.

Then it received an application for rimonabant, an obesity drug developed by French drug giant Sanofi-Aventis. As agency medical reviewers pored over the drug's clinical trial data, they discovered hints that it could cause psychiatric problems.

Unsettled by their experience with antidepressants, agency reviewers again mandated the use of Posner's system. The assessment found that the drug doubled the risks of suicidal symptoms. In June, an FDA advisory committee voted unanimously that the agency reject rimonabant because of its psychiatric effects, and Sanofi-Aventis withdrew the application although the drug is sold in Europe.

This month, results of a trial of Merck's obesity drug, taranabant, were published showing similar psychiatric problems. Meanwhile, fears have grown that drugs used to treat epilepsy, seizures and mood disorders may have similar effects. An extensive examination of these medicines by the drug agency should be completed this year.

Suddenly, agency officials realized that multiple classes of medicines might cause dangerous psychiatric problems.

"So various groups within FDA are now looking at suicidality more broadly as a possible adverse event,"said Thomas P. Laughren, director of the drug agency's division of psychiatry products.

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