GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) , 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.
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.
Revision date: July 4, 2011
Last revised: by Jorge P. Ribeiro, MD