GlaxoSmithKline (GSK), makers of the type 2 diabetes drug Avandia, agreed to pay $90 million to settle claims by 37 states and the District of Columbia that the drug company illegally promoted the medication and misled consumers about whether the blockbuster prescription medication caused deadly heart attacks and strokes in order to boost sales.
The settlement is yet another financial blow to GSK, which has already paid more than $3 billion to resolve government investigations into questionable marketing of Avandia and other drugs. One of the charges involved the company’s failure to report safety data about Avandia.
Avandia is in a class of type 2 diabetes medications known as thiazolidnediones, or TZDs. In 2010, a Food and Drug Administration (FDA) expert panel reviewed data that showed use of the drug increased the risk for fatal heart attacks. Some panelists recommended that the drug be removed from the market. However, the agency disagreed and opted instead to place severe restrictions on the drug.
Avandia became the focus of more than 13,000 lawsuits. As of July 2010, GSK has agreed to settle 11,500 of them.
A year after the FDA severely restricted the use of Avandia, the agency issued a warning for the type 2 diabetes drug Actos, manufactured by Takeda. The FDA said that studies had found that using Actos – especially long term – increased the risk for bladder cancer. Like Avandia, Actos is in the TZD family of medications.
Hundreds of lawsuits have been filed against Takeda by people who say the drug company withheld information that use of the type 2 diabetes medication could cause bladder cancer.