Questions About FDA Withholding Antidepressants Report Examined

The Los Angeles Times on Tuesday examined an FDA decision to allegedly "squelch plans" to present to an advisory committee findings of a study linking antidepressants to suicide in children (Shogren, Los Angeles Times, 4/6). House and Senate Republican leaders at a hearing last month launched investigations into whether FDA managers prevented medical officer Andrew Mosholder from presenting a safety review on antidepressants and suicidal behavior by children to an agency advisory committee. 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. After its meeting, the advisory committee recommended that FDA issue stronger warnings to physicians about the potential link between SSRIs and suicidal behavior in children. FDA in March issued a public health advisory that calls for new warning labels on 10 different antidepressants -- which included both SSRIs and other antidepressants -- to include detailed warnings about the potential risk of suicidal behavior in patients who take the medications (California Healthline, 3/31). The Times obtained an internal FDA document, "authenticated by government officials," in which Mosholder's "findings were detailed." According to the Times, the document shows Mosholder found children who took antidepressants were "twice as likely" to be involved in suicide-related behavior than those who did not. Mosholder's report has not been made public.

The Times reports that "some psychiatrists and congressional leaders were angered that the agency had kept Mosholder silent." Sen. Chuck Grassley (R-Iowa) said in a statement, "It would have been very wrong for the FDA to withhold any information it had about unintended consequences that might result from the use of antidepressants, especially for children and adolescents." Joseph Glenmullen, a Harvard University psychiatrist and author of a book on problems associated with SSRIs, said FDA's March warning was "ambiguous" and should have been stronger. He added, "Evidence that they're suppressing a report like this is an outrage, given the public health and safety issues at stake. They've been claiming there's no evidence, here's the evidence." FDA maintains an official public position that there was not sufficient data to demonstrate a link between antidepressants and suicide (Los Angeles Times, 4/6).