GSK expects Avandia legal costs of $3.4bn

Related tags Food and drug administration

GSK has set aside an additional £2.2bn ($3.4bn) to cover anticipated Q4 legal costs related to a US investigation of its diabetes drug Avandia.

In a statement released yesterday the UK-based drugmaker said it made the provision “in respect of the investigation by the US Attorney’s Office for the District of Colorado into the Group’s US sales and promotional practices and for product liability cases.”

GlaxoSmithKline (GSK) added that the move is in response to the “substantial” number of new liability claims it has received in the US related to Avandia.

PD Villarreal, SVP Global Litigation at GSK, said: “We recognise that this is a significant charge, but we believe the approach we are taking to resolve long-standing legal matters is in the company’s best interests​.”

GSK stopped promoting the drug late last year after the European Medicines Agency (EMA) withdrew marketing authorisation having determined​ the drug increases the risk of cardiovascular problems.

In the US the firm added enhanced safety labelling and usage restrictions to all rosiglitazone-containing medicines sold.

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