The Food and Drug Administration will examine clinical trial data for thousands of depressed adults to see if they, like children, suffered increased suicidal thoughts and behaviors while taking antidepressants.
Dr. Janet Woodcock, acting FDA deputy commissioner, could not say how long the exhaustive analysis would take or how much it would cost.
“It’s a huge undertaking,” Woodcock said Tuesday.
Columbia University’s analysis of pediatric clinical trial data examined just one-tenth of the information contained in adult databases.
That pediatric study — and the FDA’s own internal reviews — established a link between antidepressants and children’s worsened conditions. For every 100 children taking antidepressants, an extra two to three suffered heightened suicidal tendencies.
Those findings prompted federal advisers this month to push for strident black-box warnings to be added to labels for Celexa, Effexor, Luvox, Paxil, Prozac, Remeron, Serzone, Wellbutrin and Zoloft.
Higher rate of suicide?
The FDA now will begin to consider the same question for depressed adults.
It will start by analyzing a few of the larger drug trials. Ultimately, Columbia’s new analysis technique will be applied to all 234 clinical trials, representing 40,000 depressed adults.
“We’ll be able to see, for adults, if this type of analysis shows any change in their thinking or expression,” Woodcock said.
Already, the agency knows that depressed adults in clinical trials complete suicides at the same rate, whether they’re taking antidepressants or placebos. That earlier study was driven by the ethical dilemma raised by denying drugs to depressed adults. Researchers worried about a spike in suicides among the adults taking sugar pills.
“We found that wasn’t the case,” Woodcock said.
An analysis already conducted by the FDA found no differences in behavior or action of depressed children and adults taking Paxil.
“I’m not sure it was done the exact Columbia way,” Woodcock said.
Dr. Wayne K. Goodman, chair of the joint meeting of two federal advisory panels that called for the black-box warnings, said the new analysis could make it easier to see trends among young adults.
“We drew the line at 18,” Goodman said. “But some of the same mechanisms that could be responsible for suicidality in a small fraction of patients would be operative in people who are 19, 20, 21. Who is to say?”