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Paxil May Be Ineffective and Unsafe for Children

Drug Manufacturer Sued for Concealing Information About Antidepressant

ALBANY, NY -- June 11, 2004 -- A major drug manufacturer concealed information about the safety and effectiveness of treating children with the antidepressant paroxetine (Paxil), according to a lawsuit filed in the New York Supreme Court by state Attorney General Eliot Spitzer. GlaxoSmithKline knew that Paxil was no more effective in treating children with depression than a placebo or dummy pill would be, the complaint states. It also claims that the company had information that children and teenagers who took Paxil became more susceptible to suicide.

Mr. Spitzer wrote that GlaxoSmithKline suppressed four damaging studies concerning children who were prescribed Paxil, and only published one study, which gave Paxil mixed results. The complaint also alleges that GlaxoSmithKline's sales representatives were trained to misrepresent Paxil's medical properties and that so-called "Medical Information Letters" the company mailed to U.S. doctors failed to disclose Paxil's problems.

Paxil's "Off-label" Use

The Food and Drug Administration (FDA) has approved Paxil for treating adults, but not children. However, because the agency does not regulate the medical profession, doctors have discretion to prescribe an FDA-approved drug in ways other than that indicated on the labeling. This is called "off-label" use.

Because doctors were not provided with negative information about Paxil, their independent judgment about Paxil's "off-label" use for children was compromised, the lawsuit claims. "By concealing critically important scientific studies on Paxil, GlaxoSmithKline impaired doctors' ability to make the appropriate prescribing decision for their patients and may have jeopardized their health and safety," Mr. Spitzer said.

The lawsuit seeks to stop the company's "illegal and deceptive actions," to obtain compensation for the children and teenagers who were prescribed Paxil, and to force GlaxoSmithKline to give up its profits from the drug. It estimates that Paxil prescriptions for children totaled 2.1 million in 2002, resulting in about $55 million in sales.

FDA Warnings About Antidepressants

Paxil is an antidepressant in the category known as "selective serotonin reuptake inhibitors" or SSRIs. The FDA recently issued warnings about these drugs, stating that patients taking them should be closely monitored for adverse drug reactions, including suicidal behavior, increased depression, and violence. The warning followed an emotional FDA Advisory meeting in February in which physicians, epidemiologists, and the public offered testimony about depression. Parents spoke about children who had suffered serious injuries or committed suicide while taking antidepressants.

Currently, Prozac is the only antidepressant approved by the FDA to treat depression in children. The agency has approved none of the antidepressant drugs for use alone in treating the mood swings of manic depression or bipolar disorder, either in adults or children.

At Brayton Purcell, we are concerned about the safety and effectiveness of antidepressants and other prescription medicines. If your child or spouse is taking an antidepressant, he or she should be monitored for health problems. If you have questions about unsafe medications and your legal rights, please feel free to contact us. We have been representing injured consumers and their families for over 20 years and are well-versed in medical/legal issues. There is no charge for an initial consultation.

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