Regulatory Affairs

GSK agrees to settle Avandia lawsuits in US

PBR Staff Writer Published 26 July 2013

British drug-maker GlaxoSmithKline (GSK) has reached settlement with the attorneys general of eight US states over misleading marketing of the diabetes treatment drug, Avandia, and even agreed to pay $229m to settle the lawsuits.

Without admitting to any wrongdoing or liability, the UK company spokeswoman was quoted by The Wall Street Journal as saying that the settlement is to avoid the expense and uncertainty of protracted litigation and trial.

"Glaxo believes it acted responsibly in conducting the clinical trial program and marketing of Avandia, in monitoring the drug's safety and updating the drug's prescribing label as new information became available," the spokeswoman said.

GSK was alleged for misrepresenting the drug's safety and efficacy, as it demonstrated increased risk for heart attacks and strokes.

In 2012, Glaxo admitted in the federal court that it failed to submit to the US FDA certain clinical-trial information about Avandia.