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.