Certain Antidepressants Unsafe, Ineffective for Children, Study Finds
The antidepressants Paxil, Zoloft, Celexa and Effexor are unsafe and ineffective for most children and "especially dangerous" for children with suicidal tendencies, according to a British study published on Thursday in the Lancet, the Washington Post reports (Vedantam, Washington Post, 4/23). Paxil, Zoloft and Celexa are selective serotonin reuptake inhibitors; Effexor is a serotonin and norepinephrine reuptake inhibitor (Whalen, Wall Street Journal, 4/23). According to the study, Prozac, an SSRI and the only antidepressant approved by FDA for use in children, was the only such medication that does not increase risk of suicide in children and can benefit those with depression. The study involved no new data but marked the first scientific "meta-analysis" of all available information from clinical trials to appear in a peer-reviewed medical journal. According to the Post, the study included "negative data that have long been withheld from public scrutiny by the pharmaceutical industry" that British regulators recently released (Washington Post, 4/23). In the study, researchers wrote that "nonpublication of trials, ... or the omission of important data from published trials, can lead to erroneous recommendations for treatment." A Lancet editorial that accompanied the study said that analysis of clinical trial data "is made entirely redundant if (the) results are so easily manipulated by those with potentially massive financial gains." (Wall Street Journal, 4/23). The study "deepens the chasm between the predominantly positive American view" of antidepressants in children and a "growing stream of negative reviews" by Australian, Canadian and British psychiatrists, the Post reports. According to Tim Kendall, director of the London-based National Collaborating Centre for Mental Health and one of the authors of the study, "If I wanted to introduce a new drug for children who are suicidal and said this has very little proof of efficacy and it has an increased risk of suicide, people would say I was mad." He added, "In each of the published articles, the authors concluded the drug was either effective or safe or both. When you look at the combined evidence, it is ineffective, unsafe or both" (Washington Post, 4/23).
The debate over the use of antidepressants in children raises the question of "whether doctors have been dispensing the pills far too cavalierly despite a dearth of evidence to support their value," according to a New York Times editorial. No participants in clinical trials of antidepressants have committed suicide, but according to the editorial, "It is extraordinarily important to get the final judgment right" about the safety and effectiveness of the medications in children. The "skimpy evidence" that antidepressants can benefit children found in the study highlights the "need to test all drugs in children that will be used in children," the editorial states. The editorial concludes that pharmaceutical companies and medical experts who support the use of antidepressants in children "have a lot more work to do to make their case" and that the federal government should consider "a large and well-designed study to get a definitive answer" (New York Times, 4/23).
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.