Background: In the UK, drug regulators have cautioned against using any antidepressant but Prozac in depressed children and adolescents because the drugs have not proved effective and may increase the risk of suicidal thoughts and behavior. In the US, the FDA has warned that all patients taking antidepressants should be closely monitored by doctors, especially in the first weeks. But the FDA said that it had not concluded that the drugs caused suicidal thinking or behavior.
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Summary: The use of antidepressants in children carries a high risk of side effects and has limited benefits and their use cannot be recommended, according to an article in the current issue of the British Medical Journal (BMJ). The authors reviewed published trials of the newer antidepressants such as fluoxetine (Prozac), sertraline (Zoloft) and paroxetine, (Paxil) in children and found that the reporting of results was often misleading, downplaying serious adverse effects and overstating benefits; the study methods were questionable; and placebo effects may have played a significant part in the final findings. Pharmaceutical companies funded at least three of the four major trials, which may be failing to disclose increased suicidal activity related to the use of these drugs. Biased reporting and overconfident recommendations may be misleading doctors, patients, and families, say the authors.
Comment: This is the latest salvo in the battle over whether prescribing antidepressants to children and adolescents is appropriate. For more about the battle, see the article below.
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Healthy Kids, edited by Frederick Hecht, MD, FAAP,
FACMG, Pediatrician, Medical Geneticist, and up-to-date on children's health
Study Renews Debate Over Antidepressants for Kids
By Amanda Gardner
FRIDAY, April 9 (HealthDayNews) -- A review of existing scientific studies on the use of antidepressants by children adds fuel to the fire currently raging over the safety and efficacy of these drugs.
Specifically, Australian researchers publishing in the April 10 issue of the British Medical Journal conclude that trials of such newer antidepressants as selective serotonin reuptake inhibitors (SSRIs) for children and teens contain such "disturbing shortcomings" that they "cannot confidently be recommended as a treatment option for childhood depression."
The latest research follows a move last month by the U.S. Food and Drug Administration instructing the makers of 10 antidepressants to add a visible warning on the drug label indicating the potential for suicidal thinking and behavior.
The authors of the new review, three of whom are involved in the management of Healthy Skepticism, a nonprofit group, examined six randomized controlled trials of newer antidepressants -- Effexor and the SSRIs Prozac, Paxil and Zoloft -- that had been published in refereed journals. They concluded that the benefits were exaggerated and that the side effects -- including suicidal thoughts -- were not well-documented. The researchers added also that the studies were sometimes funded by the drugmakers, or that the researchers had been compensated by pharmaceutical companies.
"No study presented data on rates of attempted self-harm," the study said, citing what it called "the failure of drug companies to disclose increased suicidal activity."
Practicing psychiatrists, however, are dismissing the newest allegations.
"One has to keep in mind that 4,000 children and teenagers have participated in clinical trials, and there hasn't been one suicide among those 4,000 kids," said Dr. Harold Koplewicz, director of the New York University Child Study Center and author of More Than Moody: Recognizing and Treating Adolescent Depression.
"In general, [antidepressants are] an effective treatment; they have minimal side effects -- most of the time, they're nuisance side effects -- so that they're not life-threatening. They work in the majority of kids," added Koplewicz, who was an investigator on the one of the trials criticized in the article.
One of the main side effects that has concerned researchers and regulators is the potential for suicidal actions or thought. But practitioners feel there is little or no justification for this concern. "There is absolutely no evidence that suicidality is increased with these medications compared to placebo," Koplewicz said.
Furthermore, critics claimed that the authors of the review never adequately delineated what the serious adverse effects are.
"When these investigators talk about adverse effects, more often than not it's a little bit of a headache," Koplewicz contended. "They never really delineate what they mean by 'serious adverse' effects, but what they imply is suicidality, and I think that's a little disingenuous."
Dr. Jon Jureidini, lead author of the article and head of psychological medicine at Women's and Children's Hospital in North Adelaide, said that in one study he reviewed on Paxil, the serious adverse events included headache, worsening depression, suicidal thoughts, hostility and euphoria, and the hospitalization of 8 percent of the study participants.
And, he added, all the studies, including the one on Paxil, failed to follow the patients over the long term.
"Since suicide is relatively rare, you might have significantly increased risk and still would not expect to see suicides during this short period," he said.
In one trial of Zoloft, Jureidini pointed out that the difference in withdrawal rates in the placebo and drug arms were significantly different, yet the authors concluded that the antidepressant was safe and effective.
"We have no idea what they mean by serious adverse effects and, in reality, most of the adverse effects are really quite minimal -- and there's no evidence of suicidality whatsoever," said Dr. Jon Shaw, director of child and adolescent psychiatry at the University of Miami School of Medicine.
Funding by pharmaceutical companies does not necessarily compromise the results of a study, Koplewicz added.
"They state repeatedly that the fact that some of these studies were funded by pharmaceutical companies somehow taints them," Koplewicz said. "All of the studies that were published clearly stated who funded them. And since I actually participated in one of these studies, I can tell you that the rigor of the science was just as hard as when we get federal funding."
"There definitely seems to be an ax to grind," Koplewicz said of the article. "To add resistance to parents questioning treating their teenagers with depression is irresponsible. This kind of article only blows smoke and clouds and breeds fear among parents, and it does a disservice to the 2 million children and teenagers who truly have a diagnosis of depression."
SOURCES: Jon Jureidini, M.D., Ph.D., head, department of psychological medicine, Women's and Children's Hospital, North Adelaide, Australia; Harold Koplewicz, M.D., director, New York University Child Study Center, New York City, and author, More Than Moody: Recognizing and Treating Adolescent Depression; Jon A. Shaw, M.D., professor and director, child and adolescent psychiatry, University of Miami School of Medicine; April 10, 2004, British Medical Journal
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