FDA requiring suicide monitoring in drug trials

WASHINGTON The Food and Drug Administration is now requiring drug companies to closely study whether patients become suicidal during clinical trials, according to The New York Times. 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 complete suicide assessment into their clinical trials.

About four years ago, discoveries were made that showed antidepressants may cause some children and teenagers to become suicidal. Top FDA officials at first discounted the findings but commissioned researchers from Columbia University’s department of psychiatry, led by Kelly Posner, to reanalyze the drugs’ clinical trials.

The agency then received an application for an obesity drug by Sanofi-Aventis called rimonabant. As agency reviewers looked over the drug’s clinical trial data, they discovered results that were believed to be able to cause psychiatric problems.

Unsettled by their experience with antidepressants, agency reviewers again mandated the use of Posner’s system. The testing 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.

Medicines 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 by millions of patients. The FDA, however, has so far determined that the drugs’ benefits outweigh their psychiatric risks.

The last time one medicine’s side effect led the FDA to re-examine its drug approval process was in 1992, when it discovered that Seldane, a popular antihistamine, could cause dangerous heart arrhythmias. Tests revealed other drugs that could affect heart rhythms, and the agency soon mandated that almost all experimental medicines be tested for heart rhythm effects. Unlike the Seldane example, however, not every experimental drug program must use the new suicidal symptoms scale.

Posner said in an interview with The Times that, so many companies and academic research programs were adopting the suicide questionnaire that she was having trouble keeping up with the demand for its use. The questionnaire has been translated into 80 languages, and Posner has trained scores of teams of investigators from around the world on how to use it.