FDA Debates Anti-Depressant Risk to Children

EALTHBEAT: FDA debates anti-depressant risk to children


Monday, January 26, 2004 4:15PM EST

WASHINGTON (AP) - Parents of children with depression must sort through an emotionally charged controversy in deciding on treatment: Do popular adult antidepressants sometimes increase the risk of suicide when they're given to kids?

British authorities last month declared a list of common antidepressants unsuitable for children, citing that possibility. Next week, U.S. health authorities open public hearings on the issue, at which parents who blame the drugs for children's deaths are expected to face families who credit the same pills for saving lives.

It's a difficult question, as depression occurs in about 10 percent of youth, and depression can lead to suicide. Some 1,883 10- to 19-year-olds killed themselves in 2001, and specialists say there are 10 to 20 attempts for every suicide.

Antidepressants called SSRIs, such as Paxil, Zoloft and Effexor, have been long used by adults, and authorities say there's no evidence of a suicide risk for them.

But medicines can work differently in children, and only carefully controlled studies can prove if suicidal behavior is more common among youths taking SSRIs. The same holds for determining whether if a risk is proved, is the risk because the drug just did not alleviate the depression or had had some other effect.

No suicides have occurred in studies encompassing 4,000 children. But preliminary data suggest suicidal behavior and attempts, while infrequent, might be two to three times greater among users of some SSRIs: roughly 3.2 percent among children getting the drugs compared with 1.5 percent among those given dummy pills.

The possible risk was spotted after the U.S. Food and Drug Administration, seeing pediatric SSRI use rising, ordered research to see whether they work in children.

So far, the FDA has approved just one SSRI - Prozac - for use in depressed patients under age 18, but the agency says none of the others are yet proven to alleviate pediatric depression.

Lack of benefit in the face of possible risk led to Britain's warning that SSRIs other than Prozac are unsuitable for children. Here, FDA still is analyzing the research; it hopes to have recommendations by summer.

"Obviously there are many pediatric psychiatrists who believe in these drugs, but definitive advice on what to do is still pending," says Dr. Russell Katz, FDA's chief of neurological drugs. "Now, we can only say use them with caution."

For 18-year-old Jame Tierney of Kernersville, N.C., that's not enough warning. Next Monday, Jame will tell the FDA that fury and thoughts of suicide consumed her while taking Effexor - an experience her family wants the government to pay special heed to because Jame wasn't depressed when she started the drug at age 14. It was prescribed for migraine headaches.

A year of the starting dose induced some jitteriness. But when the headaches returned and the doctor doubled the dose, Jame's parents say their daughter went from a sweet, popular honor student to a raging loner.

"I hated my family, my friends and most of all myself," Jame says, describing screaming fits and hard-to-control impulses such as once lightly cutting her wrist with a razor until the pain stopped her.

Effexor maker Wyeth Pharmaceuticals wrote doctors in August to warn that while a cause-and-effect isn't certain, its studies show more suicide-related thinking in children taking the drug than those given dummy pills, including a 2 percent incidence of hostility.

The debate elicits strong emotions.

"The aim is to do no harm. Leaving it (depression) untreated is not 'doing no harm,'" says Dr. Graham Emslie of the University of Texas Southwestern Medical Center.

He co-chaired a task force of the American College of Neuropsychopharmacology that last week declared evidence that links SSRIs to suicide is too weak to justify not using them. The group points to evidence that suicides have dropped as SSRI use increased around the world, and to autopsy studies that show most suicides hadn't taken an anti-depressant, or the right dose, just before their deaths.

On the other side, critics claim SSRIs sometimes cause agitation and urgent anxiety, called akathisia, that could make certain people suicidal.

"I think these drugs have a place even in these age groups, but my ability ... to use these drugs safely is going to be enhanced if they come with the right warnings," says Dr. David Healy, director of the North Wales Department of Psychological Medicine, who helped trigger Britain's review.

Day-to-day, doctors and parents are caught in the middle.

"The kids are in distress at this moment, so we have to work with the information currently available," says Dr. Joseph Gold, director of pediatric psychiatry at McLean Hospital, affiliated with Harvard Medical School.

He's reassured at the apparent low incidence of problems and notes that older antidepressants have far more common side effects but prescribes the lowest possible dose.

EDITOR'S NOTE - Lauran Neergaard covers health and medical issues for The Associated Press in Washington.