Suicide Risks Must Now Be Measured in Drug Clinical Trails According to New FDA PolicyJan 24, 2008 | Parker Waichman LLP
Drug companies will now have to monitor patients in clinical trials for signs of suicidal thoughts and behaviors, according to an article in The New York Times. The Food & Drug Administration (FDA) quietly decided to make the change to its clinical trial policy following the realization that antidepressants increased the risk that children and adolescents could become suicidal. Critics of the FDA say the policy change is long-over due, as many drugs – including anti-smoking medications, acne drugs and those that treat obesity – have been found to contribute or cause suicidal behavior in some patients long after they were approved.
The FDA is quite secretive in the way it oversees experimental medicines, and has not publicly announced the rule change. But according to the New York Times, in recent months, the agency has sent letters 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 suicide monitoring rule represents the biggest change in FDA policy in the last 16 years. The decision to require monitoring of clinical trial participants was prompted by the agency’s experience with antidepressants. Four years ago, researchers found that antidepressants could cause some children and teenagers to become suicidal. According to the New York Times, top FDA 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, while reviewing the Sanofi-Avantis’ application to approve rimonabant, a much-heralded obesity drug, the FDA found hints that it could be linked to an increased risk of suicide. Again, it asked Dr. Posner’s team to analyze its clinical trials. According to The New York Times, 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.
Late last year, the FDA announced it would be reviewing the safety of Chantix, a smoking-cessation drug made by Pfizer, following reports that it caused suicidal thoughts and other psychiatric problems in users. Then, earlier this month, the results of a trial of Merck’s obesity drug, taranabant, were published showing similar psychiatric problems. At the same time other drugs, including those that treat epilepsy, seizures and mood disorders, showed similar side effects. According to The New York Times, FDA officials then realized that multiple classes of medicines might cause dangerous psychiatric problems.
It was then that the FDA decided to require drug makers to start monitoring clinical trials for suicide problems. To do so, those overseeing clinical trials will use a detailed questionnaire designed by Dr. Posner’s team to recognize suicide risks among participants.
But many critics of the FDA say the decision was long overdue. 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 in millions of patients. If the FDA had recognized the suicide and psychiatric problems earlier, millions of patients could have been spared untold pain.