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New data show Paxil may increase suicide risk in children.

Doctors should not prescribe Paxil to treat depression in children and adolescents, the FDA announced recently. The recommendation follows reports by British researchers that data from unpublished studies of the drug showed an increased risk of suicide among patients under 18. Both the FDA and the U.K Department of Health have promised further study of the issue, including whether the drug causes the same reaction in adults.

Paxil (paroxetine, marketed as Seroxat in Britain) is one of a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). The class also includes Prozac and Zoloft. Although the newly uncovered data specifically address Paxil, researchers say that all drugs in the class affect the brain similarly, so the side effects are likely to be the same for all of them. In litigation across the country, plaintiffs are seeking compensation for injuries due to the drugs' side effects, especially their alleged propensity to prompt violent behavior and suicide. (Lawsuits over Antidepressants Claim the Drug Is Worse Than the Disease, TRIAL, Mar. 2003, at 14.)

Andy Vickery of Houston, who has represented many plaintiffs in SSRI cases, said the new findings are significant for the lawsuits, giving more weight to plaintiffs' claims that the drugs can cause violent reactions.

However, he expressed concern that the FDA action is not enough: "The risk of SSRI-induced suicide affects both children and adults," Vickery said, "and although [British regulators] and the FDA have focused on self-directed acts of violence, these drugs can also trigger aggressive acts toward other people." He noted that these risks apply to 'all the SSRI drugs, not just Paxil.

British researchers analyzed nine studies and found that suicidal thoughts of suicide attempts were 3.2 times more likely among teens and children taking Paxil than among those taking a placebo. No studies have shown the drug to be effective against depression in those under 18, and the FDA has not approved it for such use; only Prozac has been approved for use by children. However, because doctors have prescribed Paxil to children and teens, the FDA has reopened the issue of the drug's safety.

Experts say that complications from an SSRI are most likely to arise during the first few weeks of use. For some patients just beginning treatment, the drugs can prompt severe mental restlessness, known as akathisia, leading to violent and suicidal thoughts. Children and teens may be more susceptible to this reaction than adults, experts say, because their nervous systems are still developing.

Plaintiffs allege that SSRI manufacturers knew of these risks but failed to disclose them to the FDA when the agency was considering the medications for approval. For instance, the lawsuits claim that Eli Lilly and Co., which makes Prozac, did not inform the FDA that in 1985, German health authorities initially refused to approve the drug until a warning of an increased risk of suicide was added to the label.

Plaintiff attorneys say their goal is to inform doctors of the potential risk.

"I have never disputed the fact that, when prescribed and monitored by the right doctor to treat the right condition in the right patient, these drugs can help and have helped a lot of people," Vickery said. "However, I believe that physicians need to be warned about the fact that their patients may well be in the small, vulnerable subpopulation of people whose lives might be endangered by violent reactions to SSRIs."
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Author:Jurand, Sara Hoffman
Date:Oct 1, 2003
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