A committee report released on Saturday by the Senate revives concerns about a GlaxoSmithKline PLC diabetes drug's link to heart attacks, putting pressure on the Food and Drug Administration to make changes to its drug-safety program.
The 334-page report by the Senate Finance Committee accuses drug makers GlaxoSmithKline, about having known the heart risks that the diabetes drug, Avandia, carried. The unsafe diabetes drug, which is linked with tens of thousands of heart attacks, was worked to be concealed from the public.
U. S. Senator Max Baucus, a Democrat and Committee Chairman, said regarding the report, "Americans have a right to know there are serious health risks associated with Avandia and GlaxoSmithKline had a responsibility to tell them".
"Patients trust drug companies with their health and their lives and GlaxoSmithKline abused that trust", he added.
Sen. Chuck Grassley, the top-ranking Republican on the committee, also signed on the bipartisan report.
GlaxoSmithKline, however, rejected any assertions made on the fact that the drug might not be safe, here on Saturday.
Spokeswoman Nancy Pekarek told CNN, "We disagree with the conclusions in the report. The FDA had reviewed the data and concluded that the drug should be on the market".
“Seven clinical trials on the drug prove that it is not linked to heart attacks”, said Pekarek.
“None of that data shows a statistically significant correlation between Avandia and myocardial ischemia or myocardial infarction [heart attack]”, she said.
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