We continue to believe that the company acted appropriately and responsibly in its management of Avandia.
Specifically, it is wrong to suggest that we hid or concealed safety data relating to Avandia. We made Avandia clinical trial results available on our website and shared these with regulators.
With respect to Avandia, the settlement reached in 2012 following a US Department of Justice investigation related solely to the inadvertent omissions in certain Food and Drug Administration (FDA) regulatory reports of information regarding the initiation and status of certain studies. The Department of Justice has expressly acknowledged that the information had been provided by GSK to the FDA in other forms. The FDA has also stated that the omissions did not impact the agency's evaluation of the safety data related to Avandia.
We continue to stand behind the safety and efficacy profile of Avandia in the treatment of type 2 diabetes when used appropriately. Nevertheless, we fully accept regulators' decisions to restrict its use and have worked to make sure health professionals and patients understand this latest advice and guidance.
Related news articles:
- Families face battle with GSK over dangerous diabetes drug (The Guardian)
- GSK revises US Avandia label to include new restrictions on use
- GSK regulatory update on Avandia following EMA and FDA reviews