F.D.A. Requiring Suicide Studies in Drug Trials

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.

Assessing Suicide Risks The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’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.

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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 L. Posner, to reanalyze the drugs’ clinical trials. This work caused the drug agency and its experts to view the risk as real.

Then it received an application for rimonabant, a much-heralded obesity drug developed by the 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, too.

Unsettled by their experience with antidepressants, agency reviewers again mandated the use of Dr. Posner’s system. The assessment found that the drug doubled the risks of suicidal symptoms. In June, an F.D.A. 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.