The US Food and Drug Administration (FDA), the medicines safety watchdog, responded by asking an advisory committee to look again at the safety of the drug. The British equivalent, the MHRA, said it is “continuously monitoring” the safety of Avandia.
In a report, senators Max Baucus and Charles Grassley said the FDA had not banned the drug because it was too “cozy” with drugs firms.
They quoted a memo written by two FDA reviewers which concluded: “The risks of (Avandia) are serious and exceed those for rival drug Actos.”
The reviewers said there was “strong evidence that (Avandia) confers an increased risk of” heart attack and heart failure when compared to Actos.
Up to 100,000 Britons with type 2 diabetes take the drug, which carries a warning that it might not be suitable for those with heart problems.
In 2007 a study published in the Journal of the American Medical Association, found Avandia puts users at a 60 per cent greater risk of heart failure and a 29 per cent greater risk of death than other medication.
Senator Baucus said: “Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them.
“Patients trust drugs companies with their health and their lives and GlaxoSmithKline abused that trust.”
A spokesman for GSK said it rejected the report’s conclusions. The company said the report “cherry-picks information from documents, which mischaracterises GlaxoSmithKline’s comprehensive efforts to research Avandia and communicate those findings to regulators, physicians and patients.”
via Refreshing News: Widely-used diabetes drugs can cause heart disease and death, warn experts.
GSK is winning drug war.