- The Washington Times - Monday, September 20, 2004


Alarmed at a recommendation that antidepressants for children carry a strict new warning label, some parents are not letting their youngsters take the drugs as part of a clinical trial for young people who have attempted suicide.

Government health advisers said last week that the labels on these drugs should have bold warnings surrounded by a black box to say that, in some cases, the medication increases suicidal thoughts and behavior.

A study financed by the National Institute of Mental Health is designed to determine whether treatment — medication or behavioral therapy, alone or combined — can prevent future suicide attempts.

Children enrolled in the small pilot study have attempted suicide previously, which normally would exclude them from such scientific trials.

Dr. Graham Emslie, principal investigator at one of the study’s five sites, said only 15 percent of children diagnosed as depressed take medication.

“We’re trying to increase the number who are treated,” said Dr. Emslie, who works in Dallas, and the black-box warning “is definitely not going to help.”

The Food and Drug Administration said it generally supports the recommendation from the advisory panel that labels on antidepressants have warnings about increased risk of suicidal thoughts and behavior.

For every 100 children taking antidepressants in controlled clinical trials, two to three experienced increased suicidal tendencies.

In the trial, the parents of a child who had attempted suicide within the previous 45 days — a requirement to participate in the study — refused to let researchers use an antidepressant as planned.

In a second instance, divorced parents could not agree whether their suicidal child should take the medication.

Dr. Emslie said two refusals by parents in a single week, each citing the advisory panel’s comments, mark the beginning of a worrisome trend. “I don’t think it was isolated. I think it will continue,” Dr. Emslie said.

On Capitol Hill, lawmakers are pushing for greater disclosure of the results from drug clinical trials.

The FDA said last week it has begun to adopt more strident warning labels for all antidepressants, not only those involved in pediatric clinical trials: Celexa, Effexor, Luvox, Paxil, Prozac, Remeron, Serzone, Wellbutrin and Zoloft.

The agency has not yet said whether that will be a black-box warning as the advisory panel recommended.

For psychiatrists such as Dr. Dan Medeiros, the push to ensure that doctors first discuss the medication’s risks and benefits simply reinforces what he has done for 14 years.

Dr. Medeiros runs a day treatment program for New York teenagers who skip school or fail because of depression. Dr. Medeiros’ warnings already include the risk that an antidepressant can boost energy.

“People can be so depressed they don’t even have the energy to get out of bed. If the medication starts improving energy level … you then have the means to commit suicide,” he said.

Dr. John March, chief of child and adolescent psychiatry at Duke University Medical Center, said he’s inclined to prescribe Prozac first among the new generation of antidepressants. The federal recommendations won’t change that because three studies, including one led by Dr. March, point to Prozac’s effectiveness.

Kathy Bruce’s husband, Marty, killed himself in 1993, and her 10-year-old daughter, McLain, was diagnosed as bipolar in May.

For the past month, the girl has taken Zoloft, which is linked to increased suicidal thoughts among children. When prescribing the drug, McLain’s doctor mentioned a “small risk,” Mrs. Bruce said.

“It was a risk I was willing to take,” Mrs. Bruce said from her home near Atlanta. “She’s coming home every day happy and loving school.”

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