Used Avandia?

Our DC and Boston Injury Attorneys Hold Drug Companies Responsible for Your Injuries

On February 20, 2007, a Senate report said that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public.

Sen. Max Baucus, chairman of the Senate Finance Committee, and Chuck Grassley, the committee’s ranking Republican, released the report, which follows a two-year inquiry. They are also asking the U.S. Food and Drug Administration why it allowed a clinical trial of Avandia to continue even after the agency estimated that the drug caused 83,000 heart attacks between 1999 and 2007.

FDA Avandia Warning 2007

In 2007, an FDA advisory panel voted to keep Avandia on the market, but with sterner warnings. Glaxo later that year included a “black box” warning on Avandia’s label advising that it should be prescribed with caution to patients with heart disease or who are at risk of a heart attack. The product also has a label advising it can trigger or exacerbate heart failure in some patients.

Sen. Grassley, one of the FDA’s toughest critics in Congress, disclosed that the agency’s internal safety experts came within one vote of recommending a withdrawal of Avandia.

In a letter to FDA Commissioner Margaret Hamburg that was also released, the senators said the committee’s report was based on researchers’ studies of Avandia, internal GlaxoSmithKline documents and FDA documents. They said committee investigators had interviewed GlaxoSmithKline and agency employees as well as what it called anonymous whistleblowers.

Based on its knowledge of the heart attack risks, GlaxoSmithKline “had a duty to sufficiently warn patients and the FDA of its concerns in a timely manner,” the report said.

Instead, the company tried to downplay findings that the drug could increase cardiovascular risks while also working to downplay findings that a rival medication might reduce such risks, it said.

What is Avandia?

Avandia is an oral diabetes medicine that helps control blood sugar levels by making the cells of the body more sensitive to the action of insulin.

Avandia is for people with type 2 (non-insulin-dependent) diabetes. It is sometimes used in combination other medications, but it is not for treating type 1 diabetes. Taking Avandia with insulin or nitrates is not recommended.

Avandia may also be used for other purposes not listed in this medication guide.

More than 6 million people worldwide have used Avandia (generic name rosiglitazone) since it was approved more than 8 years ago. The Food and Drug Administration issued a safety alert on May 21, 2007 — yet the drug is still in current use by about 1 million Americans.

If you or a loved one has experienced heart complications while taking Avandia, please contact the Boston and Washington DC injury lawyers of Pollack & Flanders as soon as possible.