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Posted on Tue, Sep. 14, 2004

Science panel recommends stronger warnings on antidepressants

Chicago Tribune

(KRT) - Antidepressant medications should carry "black box" warnings - the strongest caution for prescription drugs - because they can enhance the risk of suicidal thoughts among children and adolescents being treated for depression, scientific advisers to the government announced Tuesday.

Although the risk of suicidal tendencies is low, families should be counseled that it exists and sign release forms before beginning such medication for their children, the scientific panel told the U.S. Food and Drug Administration.

Psychiatrists say the recommendations, if approved, would likely make it more difficult to prescribe antidepressants for children and adolescents. Parents would face the difficult task of weighing the costs and benefits of the drugs, which also have the potential to save lives.

"Every suicide is a tragedy, and any increased risk of suicidal thoughts or behaviors - no matter how small - must be taken seriously," said Dr. David Fassler, a trustee of the American Psychiatric Association and a child and adolescent psychiatrist in Vermont.

But Fassler also testified the association was concerned that action by the FDA would frighten people away from treatment. "Half of all kids who suffer from depression will attempt suicide at least once, and at least 7 percent will die as a result," he said.

An estimated 11 million U.S. youngsters were prescribed antidepressants in 2002, the most popular of which are Zoloft, Paxil and Prozac. Prozac is the only antidepressant shown to be effective in children and it is the only one approved by the FDA for use in adolescents. Zoloft and Paxil have been found to be effective in treating obsessive-compulsive and anxiety disorders.

A re-analysis of 25 studies involving 4,600 children and teens taking antidepressants indicate that the risk of suicidal thoughts or behavior is 2 to 3 percent, compared to a risk of 1.5 percent in depressed youngsters given a placebo, or dummy drug. Psychiatrists emphasized that none of the children in the studies committed suicide.

The studies that were analyzed varied in what was considered suicidal behavior, making analysis difficult, the FDA said. For example, some subjects cut themselves, but in most cases only superficial wounds resulted.

The panel made its recommendations after two days of emotional public hearings at which some parents said they believed antidepressants may have played a role in their children's suicide. The FDA generally follows the advice of its advisory panels.

Black box warnings are usually given to anti-cancer drugs and other medications that carry a risk of causing birth defects in pregnant women, or organ failure. In 2001 the FDA required a black box warning for the antidepressant Serzone because of a risk of potentially fatal liver damage.

A number of mental health experts cautioned that the strict warning label could discourage the use of antidepressants by adolescents who need them.

"There's growing concern that the positive effects of the treatment are being outweighed by the negative effects," said Dr. Graham Emslie, chief of child and adolescent psychiatry at the University of Texas Southwestern Medical Center.

Emslie, who conducted a large study showing that Prozac was effective in adolescents, said the black box warning could cause physicians not to prescribe antidepressants for fear of being sued.

"The blanket removal of available effective treatments would be a problem," Emslie said. "We feel that choice is an important issue. Not everybody responds to the first line of treatment."

Emslie and other mental health experts said they have gotten calls from parents worried that they may not be able to get antidepressants for children who have been greatly helped by the drugs.

Dr. Wayne Goodman, chief of psychiatry at the University of Florida and chairman of the FDA advisory panel, acknowledged those concerns but said the stronger warning label should be applied.

"I think that's worth the complication, because it will raise the threshold to prescribing these drugs" to minors, he said.

Psychiatrists pointed to the recently published results of the federally funded Treatment for Adolescents with Depression Study, or TADS, which found that more than 7 out of 10 depressed youngsters responded favorably to a combination of Prozac and a form of talk therapy. Among those taking a placebo, the response rate was 35 percent.

Fassler said "most clinicians believe ... that for children and adolescents who suffer from depression, the potential benefit of these medications far outweighs the risks."

Dr. Mark Reinecke, the Northwestern professor of psychiatry and behavioral sciences who was the lead author of the TADS study, said the challenge now is to determine why drugs sometimes trigger the suicidal thoughts.

"We have to establish the markers for risk in individual children who will be receiving these drugs," he said.

To ban their use in adolescents, the way the British have done, would have been "a serious mistake," said Dr. William McKinney, director of Northwestern's Asher Center for the Study and Treatment of Depressive Disorders.

McKinney said that these drugs already are approved for use in childhood obsessive-compulsive and other anxiety disorders. "The overlap behind anxiety and depression is very, very high. So one would be depriving people of effective treatments if their use was limited in any way."


(Chicago Tribune correspondent Bonnie Miller Rubin contributed to this report.)


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