Six months after the Food and Drug Administration withheld an internal finding that anti-depressant medications were associated with an increased risk of suicide among children, a second staff analysis has arrived at the same conclusion.
The agency has refused to publicly disclose either report, despite growing pressure from critics and Congress. Agency officials say they don’t plan to discuss the data until a scheduled meeting in September, which would come nine months after British authorities warned physicians not to prescribe Paxil, Zoloft and similar drugs to depressed children and more than a year after the first concerns emerged.
The new analysis has renewed critics’ complaints that the FDA is moving too slowly to address the concerns about suicide.
One leading expert who reviewed the two internal analyses said they had changed his thinking about the risks. “I didn’t have access to the proprietary data” reflected in the FDA analyses, said Steven Hyman, former director of the National Institute of Mental Health, who initially felt British regulators had overreacted. “Now I would say from the data in front of me, with the exception of Prozac, there is concern about the risk-benefit ratio of antidepressants in children,” Hyman said.
FDA officials have declined to release the new analysis, first reported by the Wall Street Journal, and said they were still reviewing the information. Officials said tthe new “interim review” by FDA Medical Reviewer Tarek Hammad showed an increased risk for children taking the drugs similar to that found in February by another FDA scientist, Andrew Mosholder.
Hammad’s review found that compared to depressed children who got sugar pills, children who got antidepressants had 1.78 times the risk of making a suicide attempt or “making preparatory actions towards imminent suicidal behavior.” Mosholder found that children getting antidepressants had 1.9 times the risk of “serious suicide-related events.”
Multiple congressional investigations are underway into the controversy. The chairman of the Senate Finance Committee, Charles Grassley, said in a statement: “It’s been almost nine months since British regulators issued new recommendations, and it’s been six months since Dr. Mosholder made his determinations. Now, given this new information, it’s fair to ask if the Food and Drug Administration is taking too much time to draw a conclusion.”
FDA’s associate director for medical policy, Robert Temple, said in an April interview that officials believed a second analysis might provide a different answer than Mosholder’s: “Andy thinks the results are unlikely to change from this analysis, and we are not so sure of that.”
Temple said the agency had decided to withhold Mosholder’s findings because “we didn’t think it was time to present a conclusion about a study because we as an agency didn’t want to present it in the absence of all the data; you want to be careful about reaching premature conclusions.”