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news.GlaxoSmithKline (GSK) has said that the Staff Report of the Senate Committee on Finance draws conclusions on the safety of Avandia (rosiglitazone) that are based on analyses are not consistent with the rigorous scientific evidence supporting the safety of the drug.
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GSK also added that the report picked information from documents, which mischaracterized GlaxoSmithKline’s comprehensive efforts to research Avandia and communicated those findings to regulators, physicians and patients. GSK claimed that the safety and effectiveness of Avandia is well characterized in the label approved by the FDA.
GSK said that the assertions in the report, and consistent with the FDA-approved labelling, the scientific evidence simply did not establish that Avandia increased cardiovascular ischemic risk or caused myocardial ischemic events.
In 2007, the FDA considered all the available scientific evidence on Avandia, including Dr David Graham’s assertions of elevated heart attack risk and demands that the product be withdrawn. Based on the scientific evidence and a recommendation by an independent advisory committee of experts convened by the FDA, the agency has ruled that Avandia remain available to patients for the treatment of Type 2 diabetes.
GSK said: “In the years since the FDA addressed these questions about the cardiovascular safety of rosiglitazone, seven large, prospective, randomized, clinical trials have reported results. None of these randomized clinical trials, which remain the gold standard for evaluating scientific and medical questions, show a statistically significant association between rosiglitazone and myocardial infarction (heart attack) or other ischemic cardiovascular events.
“For instance, RECORD demonstrated that rosiglitazone was not associated with an overall increase in cardiovascular hospitalization or death compared to those treated with metformin and sulfonylureas. Additionally, independent investigators, Mannucci et al., have conducted the largest, most comprehensive meta-analysis of rosigltazone clinical trials to date (164 clinical trials) and found no association between rosiglitazone and myocardial infarction.
“GSK has consistently shared this data with regulators around the world, and worked with them to ensure that the Avandia product labeling is updated to add cardiovascular and other safety information as new data become available so that physicians can make the best treatment choices for their patients.”
Reportedly, the assessment of the safety of Avandia is continuing now with a clinical trial called TIDE, which was mandated by the FDA. The protocol for conducting the study was developed with and approved by FDA. The TIDE protocol has also been approved by an independent review board and appropriate safety boards that are responsible for monitoring and assessing the safety of the trial in Type 2 diabetes patients.