Have you suffered a heart attack, stroke or heart failure while taking Avandia? This controversial diabetes drug has been shown to significantly increase the risk of heart attack, stroke and other heart problems. Avandia is so dangerous that the US Food and Drug Administration (FDA) significantly restricted its sales in 2010. While not an Avandia recall, the FDA's actions mean that this defective drug will be available to far fewer patients than was previously the case. If you or a loved one took Avandia, and suffered from a heart attack, stroke or other heart problem, you may be eligible to file an Avandia lawsuit.

Much evidence exists indicating GlaxoSmithKline was not only aware of Avandia's heart attack and stroke risk, but that the drug maker made a concerted effort to hide those risks. Our Avandia injury lawyers are working right now to make sure Glaxo is held accountable for its Avandia deception. We are currently offering free Avandia lawsuit evaluations to anyone injured while taking this medication. If you suffered a heart attack, stroke or other heart problem that could be linked to your use of Avandia, please call us today to protect your legal rights.

Avandia Heart Problems

In September 2010, the FDA announced that Avandia sales would be restricted, citing the drug's 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.

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.

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, leading to calls that the drug be removed from the market completely. 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.

Glaxo's Avandia Deception

The way Glaxo handled some unflattering Avandia studies offers compelling evidence that the drug maker purposely tried to hide the drug’s heart risks. On the eve of the FDA's 2010 advisory panel meeting on Avandia, The New York Times published an article that included allegations that Glaxo had worked to cover up Avandia's heart risks since 1999. According to The Times' article, SmithKline Beecham - now Glaxo - began and completed a study in 1999 comparing Avandia to Actos, a competing diabetes drug. Not only did the study find Avandia held no benefit over Actos, it also found Avandia could be more dangerous to the heart. According to The Times, SmithKline Beecham did not submit the study's results to federal drug regulators, as is required in most cases by law.

“This was done for the U.S. business, way under the radar,” Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results that was obtained by The Times. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK.”

The New York Times also found that Glaxo conducted trials comparing Avandia with glyburide, a cheaper and older diabetes medicine. When asked by a company official via email about publishing two of those studies, Freed responded in a message dated July 20, 2001: “Not a chance. These put Avandia in quite a negative light when folks look at the response of the RSG monotherapy arm."

Then there is the infamous RECORD trial, one of the studies considered by the 2010 Avandia 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’s tally of adverse events, mistakes that further obscured Avandia’s heart risks.

Legal Help for Victims of Avandia Heart Problems

Parker Waichman LLP is one of the preeminent personal injury law firms in the US. Parker Waichman LLP is listed in Best Lawyers, the oldest and most respected peer-review publication in the legal profession. The attorneys of Parker Waichman LLP are also the authors of "Personal Injury Law for Dummies,” an easy-to-understand guide to all aspects of personal injury law.

If you’ve suffered a heart attack, stroke, or other heart problem while taking Avandia, you may be entitled to receive compensation for medical bills, lost wages, pain and suffering, and other damages. If you are interested in filing an Avandia lawsuit, please fill out our online form or call 1-800 LAW INFO (1-800-529-4636) today.