Antidepressants for Children Must Have Warnings: FDA Advisers

Panels cite possible suicide risk in urging strong action

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HealthDay Reporter

TUESDAY, Sep. 14, 2004 (HealthDayNews) -- Antidepressants prescribed to children should carry a clearly stated warning that they can sometimes trigger suicidal thoughts or actions in pediatric patients.

That was the unanimous recommendation handed up Tuesday by members of two U.S. Food and Drug Administration panels convened jointly to examine the risks of giving medications known as selective serotonin reuptake inhibitors to children, according to wire service reports.

The 25-0 vote, which was greeted with applause by tearful families at the hearing, followed two days of testimony in Washington, D.C., and mounting evidence that antidepressants like Paxil, Prozac and Zoloft may induce suicide or suicidal thoughts in some children.

The long-awaited decision comes after months of impassioned debate by physicians, parents, children and drug industry representatives on the safety of the medications.

Before the vote, the FDA advisory group also heard evidence Tuesday that tougher drug warning labels mandated by the FDA in March have had little or no effect on the sale of antidepressants to minors.

In their decision, which now goes to the FDA for action, the panelists recommended that the antidepressants carry the nation's strictest warning -- a black box on the label -- detailing the potential risks, the Associated Press reported.

They also concluded that the drugs should come with an easy-to-read pamphlet that explains how to decide if a child is an appropriate candidate for the drug and what the warning signs of suicide are. In addition, they recommended, the FDA should consider making parents sign a form that they understand the risks before a child starts taking the pills.

The FDA advisory committee chairman Dr. Wayne Goodman, who supported all the recommendations, cautioned, however, that there may be a backlash to such strong warnings, the AP reported.

"It will make prescribing more difficult. I anticipate there will be alarm from parents and the child," said Goodman, a psychiatry chairman at the University of Florida.

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

The latest FDA analysis found that antidepressant use by children triggers a 2 percent to 3 percent rise in suicidal thoughts among selected patients, independent experts found. The drugs Luvox, Effexor and Paxil were among those with the strongest correlation to suicidal behavior in young users, while pediatric patients taking Celexa, Zoloft and Prozac were deemed at somewhat lower risk, the AP said.

Tuesday's decision came one day after emotional testimony into potential links between child suicide and SSRI antidepressant use. According to The New York Times, parents on both sides of the issue made impassioned arguments before one of the FDA committees Monday, pleading either for or against open access to these drugs.

Mark and Cheryl Miller, of Overland Park, Kan., spoke of their 13-year-old son Matthew's suicide earlier this year while on Zoloft. They blame the drug for his death, the Times reported.

"Why haven't parents like Cheryl and myself and countless others been told the truth?" Mark Miller said.

But Dr. Suzanne Vogel-Sibilia, of Beaver, Pa., argued that the overwhelming majority of young patients using these medications -- including her 15-year-old son, Tony -- had been helped.

"Please help preserve my future," Tony testified. "Don't take away my medication."

According to government health data, about 7 percent of antidepressant prescriptions are for patients between 1 and 17 years of age.

Recent analyses have suggested that the number of antidepressant prescriptions in the United States has dipped by about 10 percent since the FDA began its inquiry. But Michael Evans, of the FDA's Office of Drug Safety, told the advisers in testimony Tuesday, "we did not see that."

He noted, as well, that just two-thirds of all pediatric prescriptions for antidepressants are written by psychiatrists, with general practitioners and pediatricians responsible for much of the rest.

The FDA ruling may have important ramifications for availability of drugs that help treat depression in millions and are now a mainstay in terms of pharmaceutical company revenues.

More information

Go to the FDA for more on antidepressant use.

SOURCES: Russell Katz, M.D., director, Division of Neuropharmacological Drug products, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Bethesda, Md.; Sept. 13-14, 2004, reports from The New York Times and Associated Press

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