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#85791 - 06/16/04 06:20 PM Paxil
SAR Offline
Administrator Emeritus

Registered: 12/07/03
Posts: 3310
Loc: USA

NEW YORK (Reuters) - GlaxoSmithKline Plc, 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.
What makes me maddest is that kids don't always have a lot of say in their therapy/treatment to begin with. When I tried to speak up about the way that medication and the therapists at one clinic were not working for me (this is ages 11-14), I was told that I was being rebellious and rude to the doctors.

#85792 - 06/16/04 08:08 PM Re: Paxil
LadyTheo Offline

Registered: 12/11/03
Posts: 32
Loc: ky
I know what you mean. As an adolescent I was put on many, many, many drugs. It got to the point that I had a heart attack at age 14 due to being over-medicated. Adolescents have a hard enough time trusting adults, and then the adults go and put them on meds that make them worse? It makes no since. If there is any type of serious danger involved, they should never even consider giving it to a child. Grrrrrrrr.....can you tell this makes me mad?
Lol, sorry, I went off on a tangent-this is a touchy subject for me ;\)

In order to see the rainbow, you have to endure the storms.


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