Paxil maker GlaxoSmithKline has been named in two lawsuits filed by West Virginia families who claim the drug was responsible for their children’s birth defects, just as the company agreed to settle a class action lawsuit brought by insurance companies over the drug’s suicide risks.
In December 2005, the Food & Drug Administration (FDA) announced that it was requiring Glaxo to add additional warnings about Paxil birth defects to the drug’s prescribing information after two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population. The FDA also moved Paxil from pregnancy Category C (Risk of Fetal Harm Cannot be Ruled Out) to Category D (Positive Evidence of Fetal Risk).
The West Virginia lawsuits claims that Glaxo knew that Paxil was associated with birth defects prior to the 2005 labeling change. The plaintiffs are seeking unspecified compensatory damages, pre- and post-judgment interest, court costs, a refund of all costs associated with the purchase of Paxil and disgorgement of the company’s profits from Paxil.
Both suits were filed by families who claim that the heart birth defects suffered by their children were the result of their mothers’ Paxil use during pregnancy. The lawsuits claim the women took the drug believing it to have no adverse side effects because company promotions touted the drug as a safe alternative for pregnant women. When they were born, both children suffered from congenital injuries and disorders and birth defects, as well as heart defects and developmental delays, the suits state.
Meanwhile, Glaxo has agreed to a $40 million class action lawsuit settlement that will reimburse health plans that paid for children and adolescents to receive Paxil. Paxil is not approved for use in children, but doctors are free to prescribe medications in anyway they see fit. Several studies have linked Paxil and similar antidepressants to suicide in teenagers. Last year, the FDA ordered Glaxo and the makers similar drugs to include a black box warning – the agency’s strongest safety notice – about their risks to children on the drugs’ labels
The class action lawsuit alleged Glaxo withheld negative information about the safety and efficacy of Paxil for teenagers and children. The Paxil settlement announced yesterday involves 42,000 health plans that paid for a Paxil prescription for use by a minor between January 1998 and December 2004. The insurers can recover 40 percent of their actual costs of the drugs prescribed to children and adolescents diagnosed with a major depression, or 15 percent of the cost if the diagnosis was unknown.
This is the second Paxil class action lawsuit that Glaxo has settled recently. In 2007, Glaxo agreed to pay $63.9 million to settle a lawsuit filed by consumers. The company did not admit wrongdoing in either lawsuit.
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