Washington Post Examines FDA Analysis on Potential Link Between Antidepressants, Suicide in Children

The Washington Post on Tuesday reviewed an unpublished FDA analysis of an FDA medical reviewer's finding that has "renewed the complaints of critics that [FDA] is moving too slowly" to address concerns that antidepressants are associated with an increased risk of suicide in children (Vedantam, Washington Post, 8/10). In April, FDA acknowledged that agency officials did not allow medical officer Dr. Andrew Mosholder to testify at a February public hearing about a report he compiled that found antidepressants may lead to suicidal behavior in children because they considered the results preliminary. House and Senate Republican leaders in March launched investigations into whether FDA managers prevented the release of the report.

According to unnamed FDA sources, Mosholder planned to present a preliminary report that found selective serotonin reuptake inhibitors may increase the risk of suicide in children. A senior FDA official said that Mosholder did not present the report because the results were not finalized. The original 33-page report, based on an analysis of 22 studies that involved 4,250 children and seven antidepressants, found that children who took the medications were twice as likely as those who took placebos to become suicidal. However, FDA officials raised some concerns about how Mosholder classified suicidal behavior in the report. The Wall Street Journal reviewed an FDA draft document analysis and found that the analysis is consistent with Mosholder's findings (California Healthline, 8/5).

The Post requested that Steven Hyman, provost of Harvard University and former director of the National Institute of Mental Health, also review FDA's second analysis. Hyman said the report, which contains no narrative or interpretation, showed that children who received antidepressants had 1.78 times the risk of attempting suicide or "making preparatory actions towards imminent suicide behavior" than those who took a placebo.

Hyman said he originally questioned British regulators' warning against prescribing some antidepressants to children. However, after reviewing the analysis, Hyman said, "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." He noted that because the studies in both analyses used different measures of suicidal behavior, more government-sponsored research is needed.

Senate Finance Committee Chair Chuck Grassley (R-Iowa) on Monday said, "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 [FDA] is taking too much time to draw a conclusion."

FDA spokesperson Kathleen Quinn said, "It would be premature to discuss any conclusions and results." She added, "Other people are going to have an opinion about it, but we are still reviewing it."

FDA has said that depression, not antidepressants, causes suicidal behavior. Mosholder in February recommended the agency "take the interim step" of officially discouraging the use in children of all antidepressants except Prozac, the Post reports. FDA has not done so but has added stronger warning labels to the drugs. FDA officials say they do not plan to discuss the data until a scheduled meeting in September (Washington Post, 8/10).