FDA Committee Recommends Stronger Warnings on Use of Certain Antidepressants in Children
An FDA committee on Monday recommended that the agency issue stronger warnings to doctors prescribing selective serotonin reuptake inhibitors to treat depression in children while the FDA studies the risk of increased suicidal thoughts and actions in children that take antidepressants, the New York Times reports. "Our sense is that we would like in the interim for the FDA to go ahead and issue stronger warning indications to clinicians," Dr. Matthew Rudorfer, chair of the advisory committee and a scientist at the National Institute of Mental Health, said (Goode, New York Times, 2/3). 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. 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, 2/2).
During the "emotional daylong" public hearing that took place on Monday, experts and parents testified about benefits and risks for children taking SSRIs. Rudorfer said, "We were all concerned about the stories we heard." He added that SSRIs are "very powerful but also potentially very effective" drugs, the Times reports. Dr. Thomas Laughren, team leader of the FDA's division of neuropharmacological drug products, said that the agency took the panel's recommendation "very seriously" and that it would probably issue a warning "sooner rather than later," the Times reports (New York Times, 2/3). About 2.7 million children younger than 12 and 8.1 million individuals between 12 and 17 were prescribed antidepressants in 2002, according to FDA testimony, the Los Angeles Times reports (Shogren, Los Angeles Times, 2/3).
The FDA committee has conducted an initial review of the more than 20 trials of antidepressants involving children, and members said during the hearing that the committee's findings have been "identical" to the British analysis, which prompted the British recommendation against the use of SSRIs in children, the Washington Post reports. However, FDA has requested the execution of a second analysis of the data by Columbia researchers before taking any regulatory action. Researchers at Columbia are expected to study narrative reports of adverse effects and reclassify them according to uniform criteria. Experts on both sides of the issue agree that the data is difficult to analyze because different trials used different criteria to define suicidal thought or action, the Post reports (Vedentam, Washington Post, 2/3). The FDA committee analysis indicates that of the more than 4,000 children participating in the trials, 109 patients experienced one or more possible suicide-related behaviors, Laughren said; committee members note that children already identified as suicidal were not admitted in the trials, the AP/Las Vegas Sun reports (Neergaard, AP/Los Vegas Sun, 2/3).
Several broadcast programs reported on the issue:
- CBS' "Evening News": The segment includes comments from behavioral pediatrician Dr. Lawrence Diller and Dr. Harold Koplewicz, a psychiatrist and director of New York University's Child Study Center (Kaledin, "Evening News," CBS, 2/2). The complete segment is available online in RealPlayer.
- CNN's "Live Today": The segment includes comments from Dr. Adelaide Robb, a psychologist and researcher at Children's National Medical Center (Kagan, "Live Today," CNN, 2/2). The complete transcript is available online.
- CNN's "Paula Zahn Now": The segment includes comments from Koplewicz (Zahn, "Paula Zahn Now," CNN, 2/2). The complete transcript is available online.
- NPR's "All Things Considered": NPR's Joanne Silberner reports on the start of FDA hearings on the potential link (Silberner, "All Things Considered," NPR, 2/2). The complete segment is available online in RealPlayer.