An American Senate committee has said that GlaxoSmithKline's diabetes drug Avandia poses increased risk of heart attacks, a conclusion which has been rejected by the pharma major.
The report which is based on a two-year inquiry of Avandia (Rosiglitazone), also pointed out that GSK is aware about the possible cardiac risks associated with the diabetes drug.
GSK Pharma sells two diabetes medicines — Windamet and Windia — in India. Both drugs have Rosiglitazone as one of their active ingredients, according to GSK India website.
Company officials could not be contacted to know whether the Senate committee report would have any adverse impact on the two drugs sold here.
"The totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.
"Based on this knowledge, GSK had a duty to sufficiently warn patients and the FDA (Food and Drug Administration) of its concerns in a timely manner," said the report released by senators — Max Baucus and Chuck Grassley — on Saturday.
Baucus is the chairman of the committee on finance and Grassley is a ranking member.
Rejecting the report, GSK said it draws conclusions on the safety of Avandia that are based on analyses that are not consistent with the rigorous scientific evidence supporting the safety of the drug.
The US senate report, which is partly based on the analyses conducted by two FDA safety officials, said, "there is no evidence that Avandia confers any unique health benefits over Pioglitazone (ACTOS) while there is strong evidence that Rosiglitazone confers an increased risk of [heart attacks] and heart failure compared to Pioglitazone".
The FDA has overlooked or overridden safety concerns cited by its own officials, the report added.
"Contrary to the assertions in the report, and consistent with the FDA-approved labelling, the scientific evidence simply does not establish that Avandia increases cardiovascular ischemic risk or causes myocardial ischemic events," the company said in a statement on Saturday.
The pharma major also noted the report, "cherry-picks information from documents, which mischaracterises GSK's comprehensive efforts to research Avandia and communicate those findings to regulators, physicians and patients.
"In fact, the safety and effectiveness of Avandia is well characterised in the label approved by the FDA".
The report was developed over the last two years by committee investigators who reviewed more than 2,50,000 pages of documents provided by GSK, the FDA, and several research institutes.
The two senators have also written to the FDA on Avandia and has asked to respond on or before March 4. The letter has been addressed to FDA chairman Margaret A Hamburg. When asked to comment on the Senate report on Avandia, a GSK India spokesperson said the company is looking into the matter.
"We have come to know about the issue. Since it is a global development, we are looking into it and we will get back to you in a day," the spokesperson added.