GLAXOSMITHKLINE stepped up the defence of its diabetes drug Avandia yesterday with a detailed 30-page response rejecting a critical report by US lawmakers.
The UK-based drugmaker, led by chief executive Andrew Witty, said a Senate finance committee report last week did not present “an accurate, balanced, or complete view” of information about the drug and the firm rejected allegations it had concealed safety data.
The US Senate report, by senators Max Baucus and Charles Grassley, made claims that taking the drug could lead to increased risk of heart attack.
Glaxo said there were “glaring omissions” in the Senate report.
Glaxo said it diligently studied the drug’s safety and effectiveness, and communicated its findings to governments, regulators, scientists and doctors. The firm added: “The safety of Avandia should be judged in light of all available scientific data with emphasis on long-term prospective studies.”
The US Food and Drug Administration plans to hold an advisory panel hearing in July to consider the results of new studies on Avandia. Until then, patients should continue taking it, the agency said.