FDA Panel Recommends Warning For Adult Antidepressant Suicide Risk

An FDA advisory panel on Wednesday voted 6-2 in favor of updating black box warnings on antidepressants to state that there is an increased suicide risk for young adults up to age 25, the New York Times reports (Carey, New York Times, 12/13). According to FDA's review, for every 1,000 young adults ages 18 to 24 who are given the drugs, about four will act on suicidal thoughts who otherwise would not have done so. The review found that the drugs did not increase the risk of suicide in adults ages 25 to 65 and that they significantly lowered the risk of suicide in people older than 65. Antidepressants since 2004 have carried a black box warning about an increased risk of suicidal thoughts and actions in children and adolescents (New York Times, 12/13). FDA proposed adding new warnings about suicide risk in young adults, which the advisory panel has now endorsed. The advisory panel "also encouraged the FDA to add language to the black box about the importance of treating depression in hopes that the addition of new warnings won't cause doctors to limit the antidepressant prescriptions," the Journal reports (Wall Street Journal, 12/14).

FDA Comments
Thomas Laughren, director of FDA's division of psychiatry products, said, "We don't know" why antidepressants appear to have different effects on different age groups (Graham, Baltimore Sun, 12/14). Laughren said FDA is leaning toward expanding the black box warning to include young adults, and agency officials said they will try to write language that would encourage health care providers to prescribe the drugs carefully, not abandon them, the Washington Post reports. Robert Temple, director of FDA's Office of Medical Policy, said that regulators are in a difficult position because they are obligated to warn physicians about monitoring patients for suicidal tendencies but also are concerned that the warning might lead doctors to stop prescribing the drugs (Vedantam, Washington Post, 12/14).

Testimony
Davis Shern, president of Mental Health America, said that the current black box warning for children and adolescents has resulted in a 20% drop in antidepressant prescriptions for those age groups. At the same time, Shern noted the suicide rate for children and adolescents has increased, according to some estimates. He said, "A black box warning will scare people away from treatment and end up causing greater harm than it does good" (Baltimore Sun, 12/14). Christopher Kratochvil, a psychiatrist and spokesperson for the American Academy of Child and Adolescent Psychiatry; John Mann, a psychiatrist and spokesperson for the American Foundation for Suicide Prevention; and Donna Barnes, president of the National Organization for People of Color Against Suicide, all said that new suicide warnings might harm depression patients by making them afraid of treatment. However, British psychiatrist David Healy and Harvard University lecturer and psychiatrist Joseph Glenmullen said that FDA's review downplayed the risk of suicide from antidepressants and suggested that several suicides in industry-sponsored studies were never disclosed, the Post reports (Washington Post, 12/14).

Broadcast Coverage
Several broadcast programs reported on the FDA panel's consideration of the issue:
ABCNews' "World News Tonight": The segment includes comments from U.S. residents who testified for and against increased labeling for antidepressants (McKenzie, "World News Tonight," ABCNews, 12/13).

Related ABCNews video is available online.

CBS' "Evening News": The segment includes comments from Sherri Walton, second vice president of the Mental Health Association of Arizona, and U.S. residents who testified for and against increased labeling for antidepressants (Attkisson, "Evening News," CBS, 12/13).

Video of the segment is available online.

NBC's "Nightly News": The segment includes comments from U.S. residents who testified for and against increased labeling for antidepressants (Snyderman, "Nightly News," NBC, 12/13).

Video of the segment is available online.

NPR's "All Things Considered": The segment includes comments from Joanne Silberner, health correspondent for NPR, and U.S. residents who testified for and against increased labeling for antidepressants (Norris, "All Things Considered," NPR, 12/13).

Audio of the segment is available online.

NPR's "Day to Day": The segment includes comments from Silberner (Chadwick, "Day to Day," NPR, 12/13).

Audio of the segment is available online.














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