The FDA has quietly started asking many drug companies tolook at whether drugs in clinical trials cause some patients to becomesuicidal.
The New York Times reported in January that the agency hasnot announced the change publicly because its oversight of experimentalmedicines is done in secret. But makers of drugs to treat obesity, urinaryincontinence, epilepsy, smoking cessation, depression and many other conditionsare being asked to put a comprehensive suicide assessment into their clinicaltrials.
The FDA would not tell the Times how many letters it hassent in recent months to drug manufacturers requiring them to use a suicideassessment. Many are using a scale developed at Columbia University during workfunded by FDA to reanalyze data from antidepressant clinical trials whenconcern was first raised that those drugs cause some children and teens tobecome suicidal.
Soon, the newspaper said, FDA reviewers were seeingpotential psychiatric effects in reports of trials for drugs in othertherapeutic classes and the agency began to look at the issue more broadly.
The Times said that amongmedicines still for sale, the FDA has determined the benefits outweigh anypsychiatric risks. But the agency now wants to uncover such problems morereliably and before approval.
From the March 01, 2008 Issue of MM+M - Medical Marketing and Media
