Avandia, a drug used to treat type 2 diabetes, has been linked to a significant risk of heart attack, strokes and heart failure. In 2010, the US Food & Drug Administration (FDA) severely restricted sales of Avandia. Avandia has also been restricted in Canada, and Avandia sales have been suspended in Europe. Our Avandia injury lawyers believe that people injured by this diabetes drug may be entitled to receive compensation from GlaxoSmithKline in an Avandia lawsuit.
If you or a loved one took Avandia and suffered from a heart attack, stroke or other heart problem, our Avandia injury lawyers want to hear from you today. You may be entitled to receive compensation for medical bills, lost wages, pain and suffering, and other damages. Please contact on of our Avandia injury lawyers today for a free Avandia lawsuit evaluation.
Avandia’s Sorry History
Avandia is an anti-diabetic drug in the thiazolidinedione class of drugs. It works as an insulin sensitizer, by binding to the PPAR receptors in fat cells and making the cells more responsive to insulin. Known generically as rosiglitazone, it is marketed as a stand-alone drug (Avandia) and in combination with metformin (Avandamet) or with glimepiride (Avandaryl).
Avandia was once one of the best-selling diabetes drugs on the market. In 2006, sales peaked at $2.5 billion dollars. But in 2007, doctors began to back away from Avandia after it was linked to a high risk of heart attack, stroke and other heart problems.
Since November 2007, Avandia’s label has included a black box warning the FDA’s strongest safety alert detailing its association with myocardial ischemia. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack. Since 2007, evidence of Avandia’s heart risks has continued to grow. In the summer of 2010, the FDA convened an outside advisory panel to consider Avandia once again. The panel voted 20-12 to recommend that Avandia be allowed to stay on the market. However, 10 panel members voted that its sales should be restricted and that warnings on its label regarding heart risks be strengthened.
Among the evidence considered by the advisory panel was a study conducted by Dr. David Graham of the FDA’s Center for Drug Evaluation and Research. It found that patients in the US Medicare system who took the drug may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009. Graham’s study involved 227,500 patients, making it the largest to date, and found that patients who took Avandia were 27 percent more likely to suffer a stroke, 25 percent more likely to develop heart failure and 14 percent more likely to die compared with those who took another drug called Actos.
FDA Restrictions on Avandia
In September 2010, the FDA placed severe restrictions on Avandia, citing its heart risks. The FDA’s directive means that patients in the US will only have access to Avandia if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of Avandia’s cardiac side effects. The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks, FDA Commissioner Margaret A. Hamburg, M.D. said in a statement announcing the new Avandia restrictions. We are seeking to strike the right balance to support clinical care.
At the same time, regulators in Europe announced that sales of Avandia and related drugs would be suspended. The suspension is to remain in place unless convincing data are provided that identify a group of patients that would benefit from the drugs. In November 2010, the Canadian regulatory agency Health Canada announced restrictions on Avandia similar to those in the US.
In addition to restricting Avandia sales, the FDA also ordered Glaxo to convene an independent group of scientists to review key aspects of the company’s clinical trial known as RECORD, another study considered by the advisory panel. RECORD studied the cardiovascular safety of Avandia compared to standard diabetes drugs. RECORD, which was released in 2009, did not find increased heart risks, as other Avandia studies have. It was touted by Glaxo as evidence of the drug’s safety.
However, RECORD was widely criticized on many fronts. Prior to the 2010 advisory panel meeting, the FDA posted an Avandia briefing document on its Web site that characterized RECORD as inadequately designed and conducted to provide any reassurance about the CV (cardiovascular safety) of rosiglitazone. The memo further stated that the RECORD results confirm and extend the recognized concerns regarding heart failure” and possibly suggest an increased risk for heart attacks. The FDA review of RECORD found at least a dozen instances in which patients taking Avandia suffered serious heart problems that were not counted in the trial tally of adverse events, mistakes that further obscured Avandia’s heart risks.
Finally, the FDA halted a Glaxo-funded clinical trial known as TIDE and rescinded all of the regulatory deadlines for completion of the trial. The TIDE trial was designed to compare Avandia to Actos and to standard diabetes drugs.
In September 2010, the Food & Drug Administration (FDA) placed severe restrictions on Avandia, citing its heart risks. The FDA’s directive means that patients in the US will only have access to Avandia if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of Avandia’s cardiac side effects.