THURSDAY, April 22, 2004 (HealthDayNews) -- The latest bad news on newer antidepressants is that they may not be the best treatment for children with depression and might even be harmful, according to a new British study.
The research, which appears in the April 24 issue of The Lancet, found that when data from both published and unpublished trials were combined, the risks for children taking selective serotonin reuptake inhibitors (SSRIs) and another drug, Effexor, outweighed any possible benefits from these medications. The only exception was fluoxetine, marketed under the brand name Prozac, which had a favorable risk-benefit profile.
"I'm not sure these drugs are any better than placebo," said study co-author Dr. Tim Kendall, co-director of the National Collaborating Centre for Mental Health in London. "I'm not sure it's worth using SSRIs, and it may even be dangerous, with the exception of fluoxetine."
Experts caution, however, that no one should abruptly stop use of these medications because serious withdrawal symptoms can occur. If you're concerned, discuss the use of SSRIs with your child's psychiatrist.
Kendall said there needs to be legislation requiring drug manufacturers to make unpublished data available; at the very least it should be released to those working on national guidelines. According to the study, it's often hard to get negative results published, and the drug manufacturers are under no obligation to make the results of unfavorable studies known.
To complete this study, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom required drug companies to provide Kendall and his colleagues the results from their unpublished studies.
Kendall said the researchers reviewed a total of 12 studies -- six published, six unpublished -- that compared the use of various SSRIs to treatment with a placebo.
The researchers found fluoxetine (Prozac) had a favorable risk-benefit profile, which means the benefits from taking the drug outweigh any potential risks, such as drug side effects or an increased risk of suicide.
Other SSRIs didn't fare as well. Paroxetine (Paxil) and sertraline (Zoloft) had a slightly favorable risk-benefit profile when only the published data was examined. Once the unpublished data was added, however, the risks of taking these medications outweighed the potential benefits. Both citalopram (Celexa) and venlafaxine (Effexor, which is not an SSRI) also had unfavorable risk-benefit profiles.
The medications do have their defenders, though. "These drugs have done a lot of good. You don't want to throw the baby out with the bathwater, " said Dr. Marvin Lipkowitz, chairman of the psychiatry department at Maimonides Medical Center in New York City. "But you can't just count on the pills alone. This is not like treating a sore throat."
Lipkowitz recommended that any child on antidepressant medication be monitored while they're on the drug, and he said, they need someone to talk to and lean on.
Lipkowitz added that most of the studies examined for this article contained a relatively small number of children. When a study has only several hundred children, one or two adverse events can skew the data.
In an accompanying editorial, The Lancet editors write, "The story of research into selective serotonin reuptake inhibitor use in childhood depression is one of confusion, manipulation and institutional failure. Although published evidence was inconsistent at best, use of SSRIs to treat childhood depression has been encouraged by pharmaceutical companies and clinicians worldwide."
Kendall said in the absence of any convincing evidence, he believes parents whose children are depressed should try cognitive behavioral therapy first. If there's a need for an antidepressant, he said fluoxetine seems to be the safest choice. But, he added, "You really do need to think carefully about these drugs, and I think it would be unwise to prescribe these drugs for children at risk of suicide."
More information
To learn more about children and depression, go to the American Academy of Family Physicians or the National Institute of Mental Health.
