Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

Avandia Risk of Heart Failure and Lawsuits

If you believe you may have been harmed by the use of Avandia, it is important to note that your time to file a lawsuit against the maker of the drug could be running out. The statute of limitations in many states is coming up soon, and there still may be people who do not realize that the injury they have suffered could be related to their Avandia use.

New research shows that diabetics treated with the popular drug Avandia have higher risk of heart failure and death than those taking Actos, leading Canadian scientists to conclude that “continued use of [Avandia] may not be justified.”

The findings, published in today’s edition of the British Medical Journal, are the latest blow to the controversial blockbuster drug, manufactured by GlaxoSmithKline Inc.

Researchers stressed that the findings are relative and that Actos, a product of Takeda Pharmaceuticals North America Inc., also poses heart risks, albeit lesser ones.

A 2007 study published in the New England Journal of Medicine found that Avandia’s side effects increase the risk of a heart attack by 43 percent. Then, the FDA conducted an analysis and found the risk of heart attacks increased by 38 percent with Avandia use.

Experts estimated that over 100,000 heart attacks could have been caused by Avandia since 1999. In July, 2007, an advisory panel of experts was convened by the FDA. They looked at the different risks associated with Avandia. The panel voted that Avandia increases risks of heart attacks. The advisory panel recommended the harshest warning possible [a “black box warning”] for the drug.

According to lawsuits filed, Avandia’s manufacturers knew that the drug used in Avandia had a risk profile that increased the cardiovascular risk (the risk of heart attacks and strokes).

The lawsuits further alleges that GSK then chose not to do testing to try to isolate that risk. The drug’s information was then submitted to the FDA, who approved this in the absence of any knowledge about the potential cardiovascular risk with the drug.

The study, led by David Juurlink, a scientist at the Institute for Clinical Evaluative Sciences in Toronto, involved 39,494 patients over the age of 65 who were prescribed pioglitazone (brand name Actos) or rosiglitazone (Avandia) between 2002 and 2008.

Both medications belong to a class of drugs known as thiazolidinediones (TZDs) and are used to lower blood-sugar levels in patients with Type 2 diabetes. TZDs became popular because they promised better control of blood sugars and fewer heart problems than existing treatments.

But both Avandia and Actos cause fluid retention and heart failure in some patients. Until now, it was unclear if one was safer.

Dr. Juurlink, who is also head of the division of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre, said the new research demonstrates that the “cardiac safety profiles” of the two drugs are quite different.

“Given that rosiglitazone lacks a distinct therapeutic advantage over pioglitazone, it’s not clear why physicians would continue to prescribe rosiglitazone,” he said.

Among the patients in the study, 1,563 were taking Avandia and 895 Actos.

The research team calculated that for every 120 patients treated with Avandia rather than Actos, there would be one additional hospitalization for heart failure. Similarly, an additional death would occur for every 269 patients treated with Avandia rather than Actos. The risk of heart attack caused by both drugs was similar.

Health Canada has already stated that Avandia should not be used as a stand-alone therapy, except by patients who cannot tolerate other diabetes drugs. The U.S. Food and Drug Administration, for its part, has slapped a black box on Avandia’s label, the most severe warning the agency can issue.

A serious concern is that the statute of limitations for filing lawsuits against GlaxoSmithKline is running out. The black box warning was put on Avandia on November 14, 2007, so for many states the statute of limitations expires on November 14, 2009. It is important to note that is the deadline for filing lawsuits, not for contacting an attorney.

If the injured party does not file a lawsuit by November 14, 2009, in most states, their case will may barred, no matter how meritorious their case may be. It is important to act immediately and contact the law firm as soon possible to allow us to file a case before that statute expires.

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