Under Pressure Glaxo Publishes Paxil Data
NEW YORK (Reuters) -
GlaxoSmithKline Plc (GSK.L),
responding to a lawsuit claiming it suppressed negative data
about its antidepressant Paxil, published results of trials
showing the drug is broadly ineffective in children and
adolescents and could increase risks of suicidal behavior.
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The British drugmaker released data from nine pediatric
trials on its Web Site after New York Attorney General Eliot
Spitzer filed suit two weeks ago accusing Glaxo of fraudulently
suppressing the information.
Glaxo has denied the allegations, saying it publicized the
results either in medical journals or at scientific meetings.
The data released by Glaxo earlier this week showed Paxil to be
mostly ineffective in treating youngsters.
In a letter to physicians published before Spitzer's
lawsuit, the company said that while no patients committed
suicide, there was a difference between patients on Paxil and
those on placebo in suicidal thinking and suicide attempts.
The incidence of negative events possibly related to
suicidal behavior was 2.4 percent in patients on Paxil,
compared to 1.1 percent in patients on the placebo, the company
said.
In a 30-day follow-up trial, that rate increased to 3.4
percent for patients treated with Paxil compared to 1.2 percent
in the placebo group.
Spitzer's suit claims Glaxo published only one trial, which
had mixed results, and suppressed the results of the other
studies suggesting a possible increased risk of suicidal
thinking and acts.
Paxil is approved in the United States only for adults, but
doctors are allowed to prescribe it for children on an
"off-label" basis.
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