April 22, 2004 — For children and teens suffering from depression, most antidepressant drugs are riskier and less effective than commonly thought, unpublished data show.

Doctors rely on medical-journal studies for information on how to treat their patients. But when it comes to treating depression in children and teens — a life-threatening condition — much of this information never sees the light of day.

Antidepressants for Kids — Hidden Truths?

An analysis of clinical trials of antidepressants in depressed children and teens appears in the April 24 issue of The Lancet. It is a rare document, because it includes unpublished studies obtained by a British government advisory committee. The studies focused on the popular type of antidepressants known as SSRIs. Older antidepressants don’t work well in children, so nearly all of the 11 million U.S. children who take antidepressants get SSRIs.

Published studies show that only one SSRI — Prozac — works well in kids. They find that other SSRIs — Paxil, Zoloft, Celexa, and the non-SSRI Effexor — may not be particularly effective, but aren’t harmful, either.

Unpublished studies paint a different picture, says study co-author Tim Kendall, MD, PhD, psychiatrist and co-director of Britain’s National Collaborating Centre for Mental Health. They show that with the single exception of Prozac — for which there were no unpublished studies — the risks of the other SSRIs outweigh their benefits.

“My worry is that we doctors might look at the published data and come to wrong conclusions,” Kendall tells WebMD. “There are reports that pressure is placed on researchers not to publish negative findings. We know some drug companies prohibit publication of negative data. We just don’t know how big this is.”

Reporting only good news — and stifling bad news — strikes at the trust people put in their doctors and in drug companies, Kendall says.

“Until this is resolved, there is a huge problem hanging over the medical and pharmaceutical professions,” he says. “I don’t know why these things are happening, but we have enough to suggest the selective reporting of data is problematic.”

Doctors need to know not just when and why drugs work, but when and why they don’t work, says Glenn Hirsch, MD, medical director of New York University Child Study Center.

“We really need to have that information. It is becoming clearer and clearer,” Hirsch tells WebMD. “Traditionally, negative studies are not published. The negative studies commissioned by drug companies, we don’t have that information. That is important. … If we see only positive studies, we make the assumption that a medicine works all the time. But all kinds of things make a real difference in what happens to real patients in the real world.”

Antidepressants for Children and Teens

Based on the data from the published and unpublished studies, British authorities have banned new prescriptions for all child and teen use of SSRI antidepressants except for Prozac.

But if a kid is already taking one of these drugs, Kendall says, it’s important NOT to stop without medical advice.

“The evidence we have appears not to support the use of SSRIs with the exception of Prozac in children who are depressed,” he says. “Having said that, if a child is being successfully treated with one of these drugs, they shouldn’t stop without talking to their doctor.”

Hirsch, however, does not want to see a U.S. ban on child use of SSRIs.

“I would not want the FDA to tie my hands,” he says. “I see some seriously ill kids. Not all of them respond to Prozac. A kid who is depressed has a potentially terminal illness. For that, I have to try something. I need to be able to try whatever is available.”

Hirsch is quick to point out that this doesn’t mean writing a prescription and telling the parents to bring the child back in six months.

“Depression is a serious illness, and antidepressants are serious drugs,” he says. “Dr. Kendall is right — There isn’t a whole lot of science to guide us. Unfortunately, we have two options. We can sit back and do nothing. But depression is one of the major triggers for suicide. To do nothing is to do lots of harm.”

The other option is to use these drugs — carefully. No child or teen should receive an antidepressant, Hirsch says, unless at least three things are done first:

• Suicide evaluation. Not only the child, but also the family should be thoroughly evaluated for suicide risk and suicide history.
• Full discussion of the pros and cons of antidepressant treatment.
• Monitoring. “This is the most important thing,” Hirsch says. Any child or teen taking antidepressant medications must be closely monitored for side effects and suicidal thinking.

What’s Next?

Expect to hear more about this issue. An FDA panel is looking into the question of how SSRIs should be regulated for children and teens. So far, they’ve advised only caution — and the FDA immediately responded by strengthening the warning labels on SSRIs.

The panel has asked an expert committee at Columbia University to review drug-company data and to develop a working definition of suicidal thinking and suicidal behavior. That committee’s report is due this summer — in time for the panel’s next meeting — and will strongly influence the FDA’s final decision.