Posts Tagged ‘The History of Avandia a Timeline of Avandia recall ban studies diabetes heart attack stroke attorney lawyer Rachel Montes Tom Herald El Paso Fort Worth Dallas Texas’

Avandia is a drug approved in May of 1999 to control blood sugar levels for people with Type 2 diabetes. Type 2 diabetes is a serious and life-threatening disease, which is estimated to affect approximately 18-20 million Americans. Because there are so many people with Type 2 diabetes, developing a drug that controls blood sugars levels can be a very profitable business.

However, the Avandia drugs developed by GlaxoSmithKline have been shown in studies to increase the chance of heart attack by as much as 43%. Studies have also demonstrated that risk of death from cardiovascular disease was 64% greater in persons taking Avandia. The most recent study by the FDA linking Avandia to increased risk of heart attack was released in late February 2010.

Avandia has been suspected for years of being a potentially dangerous drug. In 2002, the warning label for Avandia was strengthened. Then, in 2006, GlaxoSmithKline provided the FDA with a meta-analysis of 42 controlled Avandia clinical drug trials suggesting short-term Avandia use may be linked to a 30%-40% greater risk of heart attack and other adverse cardiovascular events compared with other diabetes treatments or no anti-diabetic therapy at all.

In 2007, cardiologist Dr. Steven Nissen published his meta-analyis of the 42 Avandia trials in the New England Journal of Medicine which concluded that Avandia use is associated with a 43% increase in heart attack risk and a 64% increase in the risk of death from cardiovascular causes. In follow up to this study, the FDA issues a safety alert on Avandia.

In June of 2007, GlaxoSmithKline published a study in the New England Journal of Medicine purporting to show that Avandia does not cause heart problems.

However, in July of 2007: A joint FDA drug safety advisory committee while voting against an Avandia, the joint committee voted 22-1 to recommend that information warning of potential for increased risk of heart attacks be added to the drug’s labeling. In November of 2007, The FDA required that GlaxoSmithKline add a “black box” warning for heart attack risks to Avandia label and package insert.

February 2010: A Senate Finance Committee published a report linking Avandia to increased risks of heart attacks and other cardiovascular events. The report is critical of GlaxoSmithKline’s conduct in the sale and marketing of the diabetes drug concluding that Avandia manufacturer GlaxoSmithKline knew of the risks associated with Avandia for years, but worked to conceal risks of the drug from diabetes patients and from the FDA.

In May of 2010, two more studies were published finding an association between the use of Avandia and an increased risks of heart attack and other cardiovascular problems. In July of 2010, the FDA joint drug safety advisory committee met and considered the risks and benefits of Avandia. The committee voted against recommending an Avandia, but instead chose to advise the FDA to add additional safety warnings to the Avandia label and to impose new restrictions on its use. On September 23, 2010: The FDA announced new restrictions on the prescription of Avandia to patients with Type 2 diabetes who cannot control their diabetes on other medications.

Montes Herald Law Group, P.C.

Attorneys: Rachel Montes and Tom Herald

1121 Kinwest Parkway, Suite 100

Irving, Texas 75063

Telephone (214) 522-9401

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