GlaxoSmithKline has reportedly reached agreements to settle Avantida lawsuits brought by about 20,000 people who allege that they suffered heart attacks and other injuries caused by side effects of their controversial diabetes drug.
According to a report by Bloomberg News, the drug maker agreed to the Avandia settlements last month as part of court-ordered mediation.
Glaxo has previously agreed to settle more than 15,000 Avandia lawsuits filed in state and federal courts throughout the United States for an estimated $700 million. The amount of the additional Avandia payments that will resolve these most recent cases has not disclosed.
All of the lawsuits include claims that Glaxo failed to adequately warn consumers and doctors that Avandia side effects included an increased risk of heart attacks and other heart problems.
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. 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.
In July 2010, an FDA advisory panel was convened to review the risks associated with Avandia. Although the panel indicated that Avandia increases the risk of heart attacks when compared to older drugs, a majority of the committee voted to recommend that the FDA allow GlaxoSmithKline’s diabetes drug to remain on the market.
Avandia was banned from the European Union, but was allowed to remain on the market in the U.S. under severe restrictions. GlaxoSmithKline has since ceased marketing of the drug, but continues to face consumer lawsuits over injuries allegedly caused by the drug.
The federal judge presiding over the Avandia litigation previously indicated that cases will be scheduled for trial if 85% of the remaining lawsuits are not settled. Based on the available information, it is unclear whether these most recent settlements meet that figure.