Government advisers seek stronger antidepressant warning

Last Updated: 2004-02-03 9:34:44 -0400 (Reuters Health)

By Lisa Richwine

BETHESDA, Md. (Reuters) - U.S. government advisers on Monday urged regulators to issue stronger warnings about possible risks of suicidal behavior among children and teenagers taking antidepressant drugs.

U.S. health officials are studying whether antidepressants can make children and teenagers suicide-prone but have not yet reached a conclusion. A Food and Drug Administration advisory panel said the agency needs to raise awareness of its concern while the probe proceeds.

"Our sense is that we would like, in the interim, the FDA to go ahead and issue stronger warning indications to clinicians regarding possible risks of these medicines." said Dr. Matthew Rudorfer, a psychiatrist with the National Institute of Mental Health.

"We think such warnings are required to elevate the level of concern and attention that practitioners use in prescribing them," said Rudorfer, chair of the FDA advisory panel.

New warnings also should go out to parents, other panelists said.

FDA officials said data showed millions of prescriptions for antidepressants were written for children and teenagers each year.

Questions about a possible link with suicidal behavior arose last year when regulators were reviewing clinical trials of children who took GlaxoSmithKline Plc's Paxil.

The other antidepressants the FDA is evaluating include Forest Laboratories Inc.'s Celexa, Solvay's Luvox, Akzo Nobel's Remeron, Bristol-Myers Squibb's Serzone, Pfizer's Zoloft, Eli Lilly and Co.'s Prozac, and Wyeth's Effexor.

Only Prozac, sold generically as fluoxetine, is approved for treating pediatric depression.

The FDA already has urged doctors to carefully watch children or teenagers taking the drugs. British health authorities have gone further by advising doctors not to prescribe most of the drugs known as SSRIs, or selective serotonin reuptake inhibitors, to anyone under 18.

At the panel meeting, tearful parents of suicide victims urged U.S. officials to ban pediatric use of antidepressants or place explicit warnings on them about a suicide risk.

Sara Bostock said her daughter became unusually frightened and jumpy within two weeks after she started taking Paxil. One night she fatally stabbed herself twice in the chest with a kitchen knife, her mother told the panel.

"To die in this violent and unusual fashion ... led me to believe Paxil must have put her over the edge," Bostock said.

An autopsy showed a high level of Paxil in her daughter's bloodstream, which indicated her body had trouble breaking down the medicine, Bostock said.

Others told the panel antidepressants were life-saving. Sherri Walton said drug treatment helped lessen her daughter's frightening, obsessive thoughts.

"There is no doubt in my mind the SSRI she is taking saved her life," Walton said. "Please urge the FDA not to take away these tools."

Wyeth, maker of Effexor, last year sent a letter telling doctors the drug was not recommended for use in children and noted reports of hostility and suicidal behavior in pediatric studies. GlaxoSmithKline Plc has promised to work with the FDA to interpret the data.

FDA officials said they will consider the panel's recommendations. They said they plan to hold another meeting on the issue in late summer.

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