FDA Committee To Examine Potential Link Between SSRIs, Suicide Risk in Children

An FDA committee on Monday plans to hold a public hearing to examine a potential link between increased risk of suicide and the use of selective serotonin reuptake inhibitors to treat depression in children, the Washington Post reports. Although Prozac, manufactured by Eli Lilly, is the only SSRI approved by the FDA to treat depression in children, many physicians prescribe to children other SSRIs only approved to treat depression in adults. Physicians each year diagnose about 1% of U.S. children with depression and prescribe medication to about half of those children, according to the Post (Vedantam, Washington Post, 2/2). Concerns about the use of SSRIs in children has increased since the British Medicines and Healthcare Products Regulatory Agency in a December letter to British physicians recommended against the use of six SSRIs in children because of a potential link to an increased risk of suicide. The FDA last October issued a public health advisory that asked U.S. physicians to use caution when they prescribe antidepressants to children and adolescents. The FDA committee has begun to review the results of 20 studies of eight antidepressants that involved more than 4,100 children because of concerns about the effects of the medications (California Healthline, 12/11/03). Although the committee will not likely complete the review until this summer, the hearing on Monday will focus on progress and whether the FDA should issue advisories before the release of the final results (Neergaard, AP/Long Island Newsday, 2/2).

Some Question Link to Increased Suicide Risk

However, some medical professionals maintain that SSRIs do not increase the risk of suicide in children, the Boston Globe reports. The American Psychiatric Association has found no "clear and convincing association," Dr. David Fassler, who plans to testify at the hearing on Monday, said (Goldberg, Boston Globe, 2/2). In addition, a report released last month by a task force of the American College of Neuropsychopharmacology found that the use of SSRIs in children appears effective and does not appear to increase their risk of suicide (American Health Line, 1/22).

Testimony of FDA Medical Officer Barred

In related news, the San Francisco Chronicle reports that FDA medical officer Andrew Mosholder, who had planned to present a preliminary report on the safety of SSRIs at the hearing on Monday, "has been barred from publicly presenting his finding" that SSRIs may increase the risk of suicide in children, according to unnamed FDA sources. A senior FDA official said that Mosholder would not present the preliminary report because the results were not "finalized." Mosholder declined to comment on the issue. According to the Chronicle, the decision not to allow Mosholder to present the preliminary report indicates that the "agency may be siding with the pharmaceutical industry in its long-running battle with critics of antidepressants" (Waters, San Francisco Chronicle, 2/1).

Broadcast Coverage

Several broadcast programs reported on the potential link between SSRIs and increased risk of suicide in children.

ABCNews' "World News Tonight": The segment includes comments from Dr. Russell Katz, director of the FDA Division of Neuropharmacological Drug Products; Dr. James McGough, director of ADHD programs for the Neuropsychiatric Institute at the University of California-Los Angeles; and Thomas Moore, a health policy analyst at the George Washington University School of Public Health and Health Services (Stark, "World News Tonight," ABCNews, 1/30). A video excerpt of the segment is available online in RealPlayer.
CNN's "Saturday Morning News": The segment includes comments from Dr. Alvin Poussaint, a child psychiatrist and professor of psychiatry at Harvard University (Feig, "Saturday Morning News," CNN, 1/31). The complete transcript is available online.
NPR's "Morning Edition": The segment includes comments from Francis Palumbo, director of the Center on Drugs and Public Policy at the University of Maryland and Graham Emslie, director of child psychiatry at University of Texas Southwestern Medical Center (Silberner, "Morning Edition," NPR, 2/2). The complete segment is available online in RealPlayer.

This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.