Antidepressants do more good than harm-Study

Intensifying the furious debate over the safety of antidepressants in children and teens, authors of a new comprehensive analysis suggest that the drugs do more good than harm, contrary to the US Food and Drug Administration (FDA) guidelines that the drugs may increase the risk of suicidal behavior in kids.

The risk of suicidal behavior in children and teenagers using some of the most popular antidepressants is negligible, the new study published online Tuesday by the Journal of the American Medical Association (JAMA) said, adding that the US authorities should consider removing mandatory health warnings from the drug packaging.

The novel analysis comes three years after the US health agency FDA ordered pharmaceutical companies to put black warning labels, the strongest possible, on antidepressants cautioning that the medications could increase the risk of suicidal thoughts and behavior in young patients.

Two years after mandating the "black box" warning on drug packaging, in 2006 the FDA published a review of 24 studies involving 4,400 children and adolescents that showed the drugs carried a twofold increased risk of suicidal behavior. However, no suicides were reported.

The most comprehensive survey of antidepressants yet for children and teenagers included data from seven studies that were not part of the earlier FDA analysis, including two large pediatric depression trials that were not available three years ago.

Like the FDA report in 2006, this study too was based on a review of numerous clinical trials, but this time authors analyzed the data using a different methodology from the federal scientists.

In their study, David Brent, professor of psychiatry at the University of Pittsburgh School of Medicine, and the lead author of the latest study, along with several of his fellow researchers found that for every child or teen who experienced such thoughts, up to dozens more were helped by the drugs.

To reach their conclusion, Brent and co-researchers analyzed data on 5,310 children and teenagers with depression, obsessive-compulsive disorder, or extreme anxiety from 27 published and unpublished clinical trials. Conducted between 1998 and 2006, all were randomized studies that compared the effects of placebos with one of several medications, including Prozac, Paxil, Zoloft, Celexa, Lexapro, Effexor, Serzone and Remeron during the first four months of treatment or less.

After examining the data of study participants who were younger than 19 years of age and were taking antidepressants for depression, anxiety or obsessive-compulsive disorder (OCD), they found that the drug-related risk of suicidal behavior was less than one percent, and that just one in 100 youngsters reported experiencing suicidal thoughts after beginning to take the medications. In contrast, the FDA analysis reported an added risk affecting about two in 100 patients.

However, there were even no suicides in any of the studies, but 3 percent of those taking the drugs reported suicidal behavior compared with 2 percent of those taking a placebo, lower than FDA’s rates of 4 and 2 percent, respectively.

The authors of the current analysis reached the conclusion that the risk associated with the medications was not statistically significant, and that the drugs were effective for the treatment of anxiety disorders and major depression in children and adolescents. "While there is a small, increased risk of suicidal thoughts in those who use antidepressants, it would be much, much riskier to not treat these children and adolescents dealing with these disorders," Brent said in a statement.

Dr. Brent said that the antidepressants are safe and effective and should be considered as an important part of treatment. "While I support the FDA's role in monitoring the safety of medications, in this case, the FDA should reconsider the black-box warning on these medications," he concluded.

Conducted by Brent and Jeffery Bridge at Ohio State University in Columbus, Ohio, the novel research was funded by the National Institute of Mental Health.