FDA adds suicide studies to drug trials

Share this article:

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. 
Share this article:

Next Article in Features

Email Newsletters

More in Features

Headliner: Proteus CEO takes an original path

Headliner: Proteus CEO takes an original path

Andrew Thompson, CEO, Proteus Digital Health

Leadership Exchange: How Do We Get Beyond the Pill?

Leadership Exchange: How Do We Get Beyond the ...

As its focus moves from manufacturing to service, pharma needs to partner with healthcare neophytes as well as established players. James Chase asks six experts to assess the risks and ...

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic ...