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 British:
Risk of New Anti-depressants Outweighs Benefit
by Erica Goode, Atlanta Journal-Constitution, December
11, 2003
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British drug
regulators Wednesday recommended against the use of all but one
of a new generation of anti-depressants in the treatment of
depressed children under 18.
In a letter sent to doctors and other health professionals, the
government regulators said that a review of data on the safety
and effectiveness of the drugs, known as SSRIs, indicated that
their benefits did not outweigh their potential risks. The
effectiveness of the drugs for treating depression in children
has not been adequately demonstrated, they said. And some data
have linked some of the drugs with suicidal thoughts and
self-harm in children and adolescents, according to a summary of
the regulators' findings, published on the Web site of the
British Medicines and Healthcare products Regulatory Agency
www.mhra.gov.uk.
The agency, the relative equivalent of the Food and Drug
Administration in the United States, said it was issuing a
strong signal to doctors not to use the drugs to treat
depression in young people.
But the agency stopped short of entirely prohibiting them,
saying there were circumstances when child and adolescent
psychiatrists would want to use them.
The agency exempted Prozac, from Eli Lilly, but recommended
against the use of six drugs: Paxil, from GlaxoSmithKline;
Zoloft, from Pfizer; Effexor, from Wyeth; Celexa and Lexapro,
both from Forest Laboratories Inc.; and Luvox, from Solvay.
The FDA is investigating whether the data support a link between
suicide and SSRIs -- selective serotonin reuptake inhibitors --
in children and adolescents.
On Feb. 2, an agency advisory committee will hold public
hearings on the drugs' possible relationship to suicide. But Dr.
Russell Katz, director of the FDA's division of
neuropharmacological drug products, said that for many reasons,
finding whether such a link existed was no easy task.
"Our view at the moment is that the risk is not particularly
well-understood or defined," Katz said. "It is not at all a
straightforward matter to figure this out."
He said there was no indication that the British regulators had
access to any studies beyond those already under review by the
FDA.
In June, the FDA warned doctors that they should not prescribe
Paxil for depressed children and adolescents until it had sorted
out the issue.
In October, it issued a health advisory that doctors should use
caution in prescribing SSRIs to young patients and should
closely monitor those taking the drugs.
Only a few of the drugs -- including Prozac, Paxil and Zoloft --
have been tested in large scale trials as a treatment for
depression in young people.
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