Parents who bought the antidepressant Paxil for their children can begin seeking reimbursements under a $64 million class-action deal settling claims that the drug's maker misled consumers about the medication's safety.
Under the deal, announced in April and granted final approval last week by a judge in Madison County, Ill., parents with proof that they bought GlaxoSmithKline PLC's Paxil and Paxil CR, a controlled-release version of the drug, can recoup out-of-pocket expenses.
Parents who no longer have pharmacy records or receipts can get up to $100 refunded by signing a claim form that carries penalties for lying.
Claim forms, which must be filed by Aug. 31, are available online at www.paxilpediatricsettlement.com.
In settling the 2004 lawsuit, Britain-based GlaxoSmithKline denies claims it promoted the drug to children while withholding information about negative side effects, including increased suicidal behavior.
"We believe we were responsible and admitted no wrongdoing," Mary Anne Rhyne, a U.S. spokeswoman for the company, said Thursday. "This case was settled to bring closure."
Plaintiffs' attorneys can claim more than $16 million in fees, which will be deducted from the settlement fund, with the remaining money available for payments to consumers.
The settlement does not require GlaxoSmithKline to notify those who may be eligible for reimbursement. Any money left over in the settlement fund is to be returned to the company.
Anyone with a personal injury claim, including the parents of teenagers who killed themselves while taking Paxil, still can sue GlaxoSmithKline, as can insurers and governmental agencies who actually paid the bulk of the money.
In a letter to doctors last year, GlaxoSmithKline and the Food and Drug Administration warned that clinical trial data on nearly 15,000 patients revealed a higher frequency of suicidal behavior in young adults treated with Paxil. The FDA reported 11 suicide attempts — none of which resulted in death — among patients given Paxil in the trials. Just one of the patients who took a placebo attempted suicide.
Given that small number, the FDA said the results "should be interpreted with caution." The trial patients suffered from psychiatric disorders, including major depression.