GlaxoSmithKline responds to British Medical Journal article regarding Avandia® (rosiglitazone)

GlaxoSmithKline responds to British Medical Journal article regarding Avandia® (rosiglitazone)

Issued: Monday 6 September 2010, London UK

GlaxoSmithKline (GSK) continues to work in the best interest of diabetes patients who face this chronic and serious disease. Patients taking Avandia should speak with their doctor about their treatment and any questions they may have regarding their medicine.

Contrary to suggestions within the article produced by BMJ journalists, GSK has carried out an extensive research programme involving more than 50,000 patients to analyse the safety and benefits of rosiglitazone.  No other diabetes medicine introduced in the last 10 years has such an extensive safety database.

We reject any suggestion that there is a lack of publicly available trial results related to rosiglitazone for independent scientific scrutiny.  We have rigorously shared our data relating to the cardiovascular safety of Avandia in a timely and transparent manner and have made extensive efforts to publish our clinical trial findings in peer review journals, at scientific meetings and via our own clinical trials website.

The company is fully committed to maintaining best practice disclosure of clinical data for all its medicines to serve the interests of patients, physicians and regulators.

The European and US medicines regulatory authorities are currently reviewing the benefit risk profile of Avandia based on the totality of the data.  GSK acknowledges the efforts of these independent bodies to apply scientific rigour to enhance understanding of the benefit-risk profile of our medicine and we will continue to work with regulatory authorities worldwide in the best interest of patients.