Paxil maker GlaxoSmithKline has agreed to pay $40 million to settle a class action lawsuit involving the drug. The settlement will reimburse health plans that paid for children and adolescents to receive Paxil. Meanwhile, Glaxo was just named a defendant in another Paxil lawsuit filed by two West Virginia families who claim the drug was responsible for birth defects suffered by their children.
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 Food & Drug Administration (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
Critics of Glaxo have charged that the company knew about Paxil’s problems with suicidal behavior long before it ever made them public. Recently, British authorities concluded a four-year investigation into whether Glaxo failed to inform drug regulators in that country about a link between Paxil and suicidal behavior in children and teens in a timely matter. Criminal charges were not pursued in that case because British laws are unclear on whether companies are obligated to report certain drug data. Glaxo’s handling of Paxil suicide data is also the subject of a congressional probe in the U.S.
negative information about the safety and efficacy of Paxil for teenagers and children
The just-settled 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.
But even as it settled this lawsuit, Glaxo faced two others in West Virginia involving birth defects allegedly caused by 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.
Glaxo knew that Paxil was associated with birth defects
The lawsuits claims that Glaxo knew that Paxil was associated with birth defects, but did not inform doctors of the risks until 2005 when it revised Paxil’s label indicating the dangers. The lawsuits 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.
In December 2005, the 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).
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