FDA adds suicide studies to drug trials
The FDA has quietly started asking many drug companies to look at whether drugs in clinical trials cause some patients to become suicidal.
The New York Times reported in January that the agency has not announced the change publicly because its oversight of experimental medicines is done in secret. But makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked to put a comprehensive suicide assessment into their clinical trials.
The FDA would not tell the Times how many letters it has sent in recent months to drug manufacturers requiring them to use a suicide assessment. Many are using a scale developed at Columbia University during work funded by FDA to reanalyze data from antidepressant clinical trials when concern was first raised that those drugs cause some children and teens to become suicidal.
Soon, the newspaper said, FDA reviewers were seeing potential psychiatric effects in reports of trials for drugs in other therapeutic classes and the agency began to look at the issue more broadly.The Times said that among medicines still for sale, the FDA has determined the benefits outweigh any psychiatric risks. But the agency now wants to uncover such problems more reliably and before approval.