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Alert on antidepressants for kids
Panel urges sterner FDA warnings on children's suicide risks

Rob Waters, Special to The Chronicle

Tuesday, February 3, 2004
San Francisco Chronicle
Chronicle Sections

Md.

After a day of anguished testimony from concerned parents, a government advisory committee Monday called on the Food and Drug Administration to issue stronger warnings about the possible dangers, including suicidal behavior, to children being prescribed antidepressant drugs.

While taking no position on whether antidepressants cause such behavior, advisers to the FDA said that both parents and doctors should be advised of possible serious adverse side effects while the government continues to investigate the controversial issue.

"We want to put a speed bump in the road," said panel chair Dr. Matthew Rudorfer of the National Institute of Mental Health. "The warnings as they exist in the current labeling are not adequate or are not being taken seriously."

The unexpected development came at the end of a daylong FDA hearing in which parents, some fighting to hold back tears, described how their children took their own lives while taking prescribed antidepressants, known as SSRIs, including such leading brand names as Paxil and Zoloft.

One Bay Area parent, Sara Bostock of Atherton, showed photographs of her daughter Cecily in her cap and gown after her graduation from Stanford University. Bostock described how her daughter, 25, died in a "violent and unusual fashion" after she became very agitated one night, three weeks after starting on Paxil, and stabbed herself to death in her parent's kitchen.

Reports began to surface seven months ago of suicidal behavior among children and adolescents taking part in controlled trials of Paxil. First British, then American regulators warned doctors to refrain from prescribing Paxil to children and adolescents.

Last December, British authorities, after a comprehensive review, issued a new advisory to doctors to stop prescribing Effexor, Zoloft and three other antidepressants in addition to Paxil.

Prozac, the best known of the SSRIs, is not among the drugs under review, and is the only one officially approved by the FDA for use among children and adolescents.

Originally, FDA officials were expected to present their own preliminary safety analysis at Monday's hearing. But, as The Chronicle reported Sunday, that analysis -- which concluded that the drugs seem to increase the risk of suicidal behaviors among children -- was pulled from the agenda because agency officials considered it incomplete.

At the hearing, Russell Katz, director of the FDA's division of neuropsychopharmacological drug products, hinted at division within the agency over the issue. "Some in the FDA believe that the data do point to an increased risk of suicidal behavior," he said.

But Katz and other senior FDA officials said more qualitative data was needed before making a final recommendation -- which could include banning the drugs from pediatric use -- and have contracted with experts at Columbia University to review clinical trials that turned up evidence of what may have been suicidal behavior among children taking antidepressants.

In addition to suicidal behavior, other suspected side effects of antidepressants include agitation, anxiety and hostility.

Testifying at Monday's hearing, FDA medical reviewer Dr. Thomas Laughren said that among 25 studies of antidepressants involving 4,000 children and teens, there were no successful suicides. But 109 patients experienced one or more possibly suicide-related behaviors or attempts, he said.

Such behaviors include self-cutting and may be caused by a documented side effect from the antidepressants known as akathisia, which causes extreme agitation and restlessness -- a feeling some liken to "crawling out of my skin."

The panel expressed particular concern about the parents' reports about akathisia.

"Perhaps just looking at suicide attempts may not be all the answer," said Dr. Joan Chesney, a University of Tennessee pediatrician, a panel member who later urged the advisory committee to recommend the issuing of stronger warnings about the drugs.

Dr. Norman Fost, a University of Wisconsin pediatrician and bio-ethicist, said that until the FDA completes its studies, "you should be very alert to the risks of these drugs, be very alert to this ... syndrome."

While the large majority of speakers at the hearing had wrenching stories to tell, some spoke in support of the drugs.

Sherri Walton, representing the Mental Health Association of Arizona, said that antidepressants had done wonders for her 14-year-old daughter, Jordan, who suffers from obsessive-compulsive disorder.

"The SSRI medications saved her life," said Walton. "Please take no actions that would harm my child."

Some FDA officials feared that prematurely issuing serious warnings could prevent patients from receiving treatment they might badly need. "To err in either direction has significant consequences," said Laughren.

FDA officials said the investigation would probably not be completed until next summer and that another public hearing would be held before then.

About 11 million prescriptions for SSRIs were written for children under 18 in 2002 in the United States, according to the FDA.

Chronicle news services contributed to this report

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