NEWS: FDA Warns of Possible Link Between Antidepressants and Adult Suicide Risk

[Guest guest]

FDA Warns of Possible Link Between Antidepressants and Adult Suicide

Risk

By Peggy Peck, Senior Editor,

July 05, 2005

Also covered by: CBS News, Fox News

ROCKVILLE, Md., July 5-Adults using antidepressants may have an

increased risk of suicidal behavior, especially when initiating

treatment or when changing doses, said the FDA.

In a Public Health Advisory issued Friday, the FDA said recent reports

extended the link that has already been suggested in adolescents to

adults as well.

The agency advised that close observation of patients is particularly

important when antidepressant therapy is initiated or when doses of

antidepressants are changed. The advisory warned that patients taking

antidepressants may initially experience a worsening of depression and

increased suicidal thinking or behavior. Worsening symptoms require

that patients be re-evaluated by their healthcare providers, said the

FDA.

The FDA also issued a separate alert concerning Cymbalta (duloxetine

hydrocholoride). In open-label extensions of studies that investigated

Cymbalta for stress urinary incontinence there was an unexpected rate

of suicide attempts, which prompted the FDA alert.

The agency noted, however, that there have been no reports of excess

suicides in clinical trials of Cymbalta for depression or diabetic

neuropathic pain, which are the approved indications for the drug. The

drug is not approved for stress urinary incontinence.

The FDA said it is reviewing available data to determine whether there

is solid evidence linking antidepressants to increased risk of suicide

in adults.

As part of that review process, it has asked manufacturers to provide

information from their trials, using an approach similar to that used

in the evaluation of the risk of suicidal behavior in the pediatric

population taking antidepressants.

The FDA said it not likely to have a quick answer to the

antidressant-suicide question because it plans to review hundreds of

clinical trials, a process that is likely to take years rather than

months.