Study questions antidepressant-suicide link

The Food and Drug Administration has a blanket warning on antidepressant medications stating they increase the risk of suicidal thoughts and behaviors among kids and young adults, but a new review of clinical data finds no link between suicide and at least two of the medications.

The new analysis, based in part on previously unpublished data, also concludes that treatment with antidepressants decreases the risk of suicide among adults of all ages.

"These results have to instill some additional confidence that prescribing these medications is not necessarily going to lead to suicidal thoughts or behavior," said Robert Gibbons, a professor at the University of Chicago and lead author of the study, published in Archives of General Psychiatry.

The findings - based on data for kids and adults using fluoxetine (Prozac) and for adults on venlafaxine (Effexor) - are not enough to change everyone's view of the risks of antidepressants, especially to kids.

"The authors in this study examined the risk of suicidal thinking or behavior associated with one drug, fluoxetine," said Jeff Bridge, a researcher at Nationwide Children's Hospital in Columbus, Ohio. "My view is that the weight of evidence shows a small but significant increased risk of suicidal ideation/suicidal behavior in pediatric patients treated with antidepressants."

Bridge's position is in line with the FDA's current stance on suicide risk for children taking antidepressants.

In 2004, the agency asked manufacturers of antidepressants to include what's called a "black box" warning on its packaging for the medications, alerting physicians, patients and parents to an increased risk of suicide among children taking the drugs. (See FDA announcement at 1.usa.gov/yjXP1G).

Three years later, the FDA expanded that warning to include young people up to age 25.

Gibbons has long been opposed to the labeling. As an advisory board member to the FDA, he voted against adding the warning to antidepressant packaging.

"I didn't think the data were very convincing, and I was concerned physicians would stop prescribing antidepressants," he told Reuters Health.

The FDA had looked for any reports of suicidal thinking or action among 4,400 children who were in clinical trials comparing an antidepressant drug to a fake drug called a placebo.

They found that suicidal thoughts or attempts were twice as common among the kids taking an antidepressant, although none of the children had committed suicide.

To get a better handle on the risk of suicide over the course of treatment, Gibbons' team gathered data from experiments that compared the antidepressants to placebo and that had measured suicide risk from the get-go.

Some results came from a study of adolescents by the National Institute of Mental Health and the rest came from two drug makers, Eli Lilly, which markets Prozac, and Wyeth, whose parent company markets Effexor.