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
