GlaxoSmithKline has agreed to pay another $90 million to settle Avandia lawsuits, this time resolving claims brought by 38 different states that alleged the drug maker deceived Medicare programs about the safety and effectiveness of their controversial diabetes drug.
Despite agreeing to pay more than a billion dollars so far in Avandia settlements, GlaxoSmithKline continues to deny that they provided misleading or inaccurate information about the potential Avandia side effects.
Avandia (rosiglitazone) was a popular type 2 diabetes drug that was used by millions of people before it was linked to an increased risk of heart attacks and heart problems. As a result of the potential health risks, the FDA has now severely restricted access to Avandia.
The company has previously settled more than 25,000 Avandia injury lawsuits brought on behalf of former users who suffered serious or potentially fatal injuries.
In July, Glaxo agreed to the largest healthcare fraud settlement in U.S. history, including fines and civil claims of about $3 billion over its marketing of Avandia, Paxil and Wellbutrin.
Some estimates suggest that more than 100,000 heart attacks may have been caused by Avandia since it was introduced.
After concerns about the Avandia heart risks first surfaced in May 2007, the FDA required a “black box” warning, which is the strongest warning that can be placed on a medication label. However, many critics continued to argue that the warning was not strong enough and called for federal regulators to issue an Avandia recall because the risks greatly outweigh any benefit provided by the medication.
Although Avandia was banned from the European Union, the medication was allowed to remain on the market in the United States under severe restrictions. GlaxoSmithKline has since ceased marketing of the drug.