Antidepressant/Child Suicide Risk Slim
Study: Depression Drugs' Benefits for Kids Far Outweigh Suicide Risk
Antidepressant Benefit vs. Suicide Risk continued...
In 2004, the FDA presented to its expert advisory panel an analysis of much the same data. Using a different statistical approach, that analysis came to a much different conclusion. It found little evidence that antidepressants helped kids but found a small but significant risk of suicidal thinking. It led to the panel's eventual 18-5 vote to put the black-box warning on the drugs' labels.
Robert Gibbons, PhD, professor of psychiatry and director of the Center for Health Statistics at the University of Illinois at Chicago, was one of the five panel members who voted against the black-box warning.
"The FDA presentation showed very little benefit -- so most panel members said, 'Why tolerate even the slightest risk?'" Gibbons tells WebMD.
"The Brent study is showing that the FDA overestimated the effect of antidepressant medications on suicidality and dramatically underestimated the efficacy of antidepressants in the treatment of childhood depression," Gibbons says.
Weighing Antidepressants' Suicide Risk
None of the kids or teens in antidepressant clinical trials actually tried to kill themselves. But some said they thought about suicide or even made preparations for suicide. Even the Brent study found some link between this "suicidality" and antidepressant use.
"Did the drugs make people more disinhibited and more likely to report suicidal thoughts?" Brent asks. "Almost all of these events were suicidal thoughts that increased. There were no suicide attempts and no suicide completions. So while this is a concern, it is not clear what the importance of these events really is."
The real question, Brent says, is whether the possible benefits of antidepressant treatment outweigh the possible risks. One way of looking at this is to compare the "number needed to treat" -- that is, the number of kids who must be treated to ensure that one kid gets a benefit -- to the "number needed to harm," in this case the number of kids who must take antidepressants before one has a suicidal thought.
Brent and colleagues found that for every three to 10 children and teens treated with the drugs, one got a significant benefit. Out of every 112 to 200 children and teens treated, one had suicidal thoughts.