Healthy Skepticism Library item: 1463

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Publication type: news

Foster J.
FDA advisory urges caution in children's use of antidepressants
The Herald 2003 Oct 28

Full text:

Two antidepressants that will be a key focus in the trial of a Chester County teen accused of killing his grandparents were among the drugs listed in an advisory released Monday telling doctors to exercise caution in prescribing them.

The U.S. Food and Drug Administration recently completed a preliminary review of reports for eight antidepressants, classified as selective serotonin reuptake inhibitors. The studies found an excess of suicidal thoughts or behavior in clinically depressed patients using several of the antidepressants compared to those using a placebo. The drugs studied were citalopram, fluoxetine (Prozac), fluvoxamine, mirtazapine, nefazodone, paroxetine (Paxil), sertraline (Zoloft) and venlafaxine.

Pittman took Zoloft, Paxil

Christopher Pittman, 14, accused of killing Joe Frank and Joy Roberts Pittman in 2001 when he was 12 years old, was on Zoloft at the time of the killings. Christopher previously was on Paxil. His father, Joe D. Pittman, has said the drugs can be blamed for his son’s violent behavior.

The FDA has determined that additional data and analysis, as well as public discussion, are needed, according to the advisory. Thomas Laughren, the FDA’s team leader for psychopharmacological drugs, told The Washington Post the FDA isn’t suggesting the drugs can’t be used in patients under 18.

“We’re saying one should proceed with caution,” he told the newspaper. “Once we analyze the data more fully, we’ll be in a better position to make a more formal recommendation.”

Only Prozac has been approved by the FDA for use in adolescents and children.

The nonprofit group International Coalition for Drug Awareness is pushing for Congressional hearings into potential hazards of children using antidepressants. The FDA is scheduled to hold an advisory meeting Feb. 2.

The coalition will attend and present the Pittman case as an example that Zoloft should not be prescribed to children, said Lisa Van Syckel, the group’s New Jersey coordinator.

Van Syckel said Monday the FDA advisory wasn’t explicit enough in speaking to the dangers of antidepressants among children. She said the advisory “sugar coats” the problem.

“They’re not painting the full picture. The FDA wasn’t bold enough,” she said. “They didn’t have the strength and the courage to tell the truth.”

Van Syckel cited studies of antidepressants in England that led the British government to ban Paxil from use in children due to increased tendencies of suicide and violence.

Van Syckel will put her statement for the February hearing with the FDA on video and will read The Herald’s recent two-part series on the Pittman case, she said. “It brought me to tears,” she said of The Herald’s series, which concluded Monday. “I’m hoping to bring at least two or three members of that advisory panel to tears.”

Above all, Van Syckel said parents can’t rely on the government or anyone else to monitor children who are prescribed antidepressants.

“We as parents need to do it ourselves,” she said. “We need to keep our children safe and we need to keep the children around them safe.”