Sept. 13, 2004,
Researcher warns against antidepressants for
WASHINGTON - A Food and Drug Administration epidemiologist who
triggered a closer look at suicidal behavior among children taking
antidepressants cited independent experts at hearings today who he
said support his findings.
In addition to seeing increases in suicidal thoughts among
children receiving all the antidepressants he studied, Dr. Andrew
Mosholder noted a clustering of serious events involving suicide
within the first four days after youths discontinued Paxil
Mosholder testified before two FDA panels considering whether
agency action -- including stronger warning labels -- is needed on
antidepressants because they have been linked to suicidal tendencies
among children who take them. The joint panel will weigh the
benefits of nine drugs given to depressed children against the risk
that the remedies may increase suicidal thoughts and suicidal
actions among those youths.
Mosholder said analyses of data confirmed "an association of
suicidality with antidepressant drug treatment."
He was praised by grieving family members, who wore pins and
carried posters and oversized photographs of deceased children whose
deaths they blame on antidepressants. Last year, he had requested
clarification from GlaxoSmithKline and received data in May 2003
that suggested a link between the company's drug Paxil and increased
suicidal acts among children taking the antidepressant.
"He was finally allowed to speak. Last time, he was muzzled,"
said Vera Hassner Sharav, president of the Alliance for Human
Dr. Robert Temple, director of FDA's office of drug evaluation,
told reporters he had no regrets delaying the testimony at a
previous hearing because he still fears Mosholder's data are flawed.
"Scaring people needlessly, overdoing it, is worrisome also," Temple
Last June, the FDA issued a public warning about Paxil. In July,
FDA asked all antidepressant manufacturers to resubmit clinical
Independent experts, working with Columbia University, were asked
to review the research. This summer, the Columbia reanalysis came to
conclusions that backed Mosholder.
An additional 2 percent to 3 percent of children are likely to
incur increased suicidal thoughts from taking any antidepressant,
Tarek Hammad, an FDA senior medical reviewer, testified.
Hammad told reporters that looking at all the drug company
studies painted a more nearly complete picture. "Then, you can see
significant findings," Hammad told reporters.
Relative risks of suicidal behavior or thoughts were highest
among youths taking Luvox, Effexor and Paxil and lower among youths
taking Celexa, Zoloft and Prozac.
Temple said it was "interesting and persuasive" that studies link
all antidepressants to heightened suicidal thoughts and actions
among youth. "They all lean the same way, including Prozac now," he
Researchers discussed charts that explained individual tragedies:
an 18-year-old heeding a voice that called the teen to the roof, but
then refusing to jump; self-inflicted cuts that looked like cat
scratches; suicidal role-playing with knifes and hanging ropes.
The descriptions brought tears to Lisa Van Syckel, 43, who
recognized the self-destructive actions of her daughter while the
15-year-old was taking Paxil. Van Syckel was among 73 family members
who reopened painful wounds to prod the FDA to order more strident
warning labels on antidepressants they blame for their children's
Most medicines children take are prescribed off-label, meaning
they are not specifically designed or approved for use in children,
said Dianne Murphy, director of FDA's office of pediatric
therapeutics. Some 100 pharmaceutical products subjected to 200
studies found that about one-quarter of the time, the FDA had
changed the dosages for children, found new adverse reactions that
occurred only among children or found the drugs didn't work in kids