There may be more upside than downside to treating young patients with antidepressant medications.
A new study indicates the benefits outweigh a slightly elevated risk of suicidal thoughts in children and adolescents who use the drugs for treatment of depression, anxiety or obsessive compulsive disorder, said co-investigator Dr. David A. Brent, of the University of Pittsburgh School of Medicine.
The researchers took a look at the issue after an earlier U.S. Food and Drug Administration review found youngsters had more suicidal thoughts and behaviors when they were treated with antidepressants as compared to placebos. As a result, the agency issued a "black box" warning on the drugs. That is the most serious warning a drug label can bear.
Subsequently, the number of prescriptions for the medicines dropped.
"We were concerned because people have become increasingly reluctant to use antidepressants in children and adolescents in the wake of the FDA black box warning," Dr. Brent said.
"We felt, in light of the fact that depression is a potentially fatal illness, that it was important to look at the benefits against the risks, rather than just focusing on the risks."
He and his colleagues conducted a meta-analysis that pooled data from 27 studies, and their findings were published in today's Journal of the American Medical Association.
The new analysis, which was led by a Pitt researcher who is now at Ohio State University, indicates that fewer than one out of 100 participants in the studies had new thoughts of suicide while taking drugs such as Paxil, Prozac and Zoloft.
In other words, "you'd have to treat 1,000 people with a drug to get seven cases of suicidal thoughts above and beyond what you get with placebo," Dr. Brent explained. So, "you really want to be careful before you're warning people that these medications are dangerous."
He noted also that even fewer study participants attempted to commit suicide, and none succeeded.
From a benefits perspective, 10 people with major depression, six with obsessive compulsive disorder or four with anxiety would have to be treated with the medicines to prevent a harmful outcome in one patient, the researchers said.
Meanwhile, the suicide rate among Americans younger than 20 went up by 18 percent from 2003 to 2004, noted psychologist David Shern, president and chief executive officer of the advocacy group Mental Health America.
He added that while there is no evidence the increase is connected to the warning, that trend is disturbing, because in the decade prior to the warning, suicide rates were on the decline among older adolescents.
"The risks of under-treatment or no treatment may outstrip those modest increases, in this case, in the rate at which people report suicidal thoughts," Dr. Shern said.
Because of that concern, Dr. Brent contends the FDA may have overreacted and should perhaps reconsider its action.
If an objective review supports the new findings, he said, then the warning "should be removed and they should have some other type of cautionary note."
Dr. Shern said he "didn't want to beat up on the FDA," but all the experts "need to leaven these messages better than we've done in the past." The public may not have understood that the warning was issued because of an increase to 4 percent from 2 percent in suicidal ideation in the original review, he added.
The new analysis found similar results in the increase in suicidal thoughts and behaviors, and that the agency has never said the drugs don't work, only that they have not been shown to work in children, said FDA official Dr. Robert Temple.
