In 2004, after an extensive review, the Food and Drug Administration issued a strong warning to doctors who prescribed antidepressants to teens and children.
Antidepressants, the FDA said, appeared to increase suicide among kids and teens. Doctors needed to be careful. The FDA even mandated that a "black-box warning," the strongest type, be placed on antidepressant packaging.
This warning and worries that giving antidepressants to children might cause them to kill themselves was front-page news for weeks and appeared to changed the prescribing behavior of doctors.
Fewer doctors used antidepressant medications with their young patients and, according to at least one study, the number of suicides among kids and teens began to rise.
This week the Archives of General Psychiatry published an analysis that finds no increase in suicide among young people taking Prozac. The findings put a new wrinkle in the long-running debate over the safety of the medicines when used to treat depressed young people.
The study reviewed detailed data from over 9,000 patients — including 700 youths — who took the antidepressant Prozac and found that the drug didn't increase suicidality in children at all. It also looked at data for adults taking Effexor.
Now, the main author of the study is Robert Gibbons, a statistician at the University of Chicago's medical school. Gibbons sat on the panel of experts that advised FDA to issue the warnings, but he always felt ambivalent about the panel's decision.
"I worried that what we might end up with was a real epidemic of suicide," Gibbons told Shots. "And the data suggests that that is exactly what happened. Rather than the black-box warning leading to decreases in child suicide rates, they were followed by some of the largest increases in child suicide rates both here in America and around the world."
So why did the new study come to such a different conclusion about the risks of suicide in kids?
According to Gibbons, the FDA's findings and his findings are similar in some respects. Both found that when doctors asked their patients about suicidal thoughts and behavior in the context of regularly scheduled checkups there was no difference between the medications and placebos.
But when it came to what are called adverse event reports, there was a difference between his study and the review done by the FDA.
Adverse event reports occur when patients spontaneously contact their doctors with problems associated with taking a medication. When the FDA looked at these patient reports, they found that patients on antidepressant medications reported 80 percent more suicidal thoughts and behavior than patients on placebos.
Gibbons didn't look at these spontaneous reports in the same way. He only considered them when patients acted on their suicidal thoughts with a suicide attempt. He found that the small number of people who acted on their suicidal thoughts did not affect the overall risk of suicide.
The original FDA study also included all antidepressants — not just Prozac. That might account for some of the differences found.
Gibbons, who has become a vocal opponent of the black-box warnings since his stint on the committee that advised FDA, says that he hopes this study will reassure clinicians about the safety of the drugs. It's not clear whether other researchers will agree with him that the new study's findings present a fundamental challenge to the FDA's previous conclusions.
The FDA was contacted for this report, but a spokeswoman emailed that the agency doesn't respond to every report or study.
The Gibbons study was funded by the National Institute of Mental Health and the federal Agency for Healthcare Research and Quality. Gibbons has been an expert witness for the Justice Department and Pfizer in cases related to antidepressants, anticonvulsants and suicide.