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Age of patient when antidepressant(s) prescribed:

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Spitzer Says Glaxo Withheld Paxil Info

Jun 3, 2004 | USA TODAY A leading drug company withheld information and misled doctors about the safety of treating kids with Paxil, a widely used antidepressant, says a lawsuit filed Wednesday by the New York state attorney general's office.

The lawsuit, filed in the New York State Supreme Court in Manhattan, charged London-based Glaxo-SmithKline (GSK) with fraud for its failure to disclose crucial findings that suggested Paxil didn't work well on kids and could potentially trigger suicidal thoughts.

That action adds to concerns about the safety of this class of drugs, called selective serotonin reuptake inhibitors, or SSRIs, when used to treat kids with depression. Britain has banned Paxil for kids because of the suicide risk. And in March, the U.S. Food and Drug Administration asked drug companies, including Glaxo, to put a warning on drug labels about the potential risk of suicide.

Prozac is the only SSRI with FDA approval for the treatment of depression in kids. A study presented Tuesday at a scientific meeting showed that Prozac can safely combat depression in teenagers. But doctors also widely prescribe Paxil and other antidepressants for children.

The lawsuit alleges that starting in 1998 GlaxoSmithKline suppressed negative information from scientific studies. The company did at least five Paxil studies but publicized just one, the only one that held out hope that the drug might combat depression in children, says Attorney General Eliot Spitzer.

The others showed the drug offered no benefit and in some cases might have increased the risk of suicide in teens. But the company continued to market it aggressively to doctors and claimed the drug had a "remarkable efficacy and safety in the treatment of adolescent depression," the lawsuit alleges.

"Doctors prescribed Paxil based on information that was false," Spitzer says. Physicians wrote more than 2 million prescriptions for Paxil to treat children and adolescents in 2002. U.S. sales for that market brought the company $55 million in 2002, the lawsuit says.

Spitzer wants Glaxo to return the profit from the improper sale of Paxil in New York.

"GlaxoSmithKline has acted responsibly," countered spokeswoman Mary Anne Rhyne. She says the company gave crucial information about Paxil both to regulatory agencies such as the FDA and to doctors.

Experts hope such lawsuits will discourage drug firms from hiding negative scientific findings that might affect drug sales. Barry Perlman, president of the New York State Psychiatric Association, says that doctors can't make good decisions about whether to prescribe a drug if they don't have all the facts.

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