GlaxoSmithKline (GSK) is expecting to pay $3.4 billion to settle legal charges relating to its diabetes drug Avandia, as well as sales and promotional practices in the US for other products. The amount is in addition the $2.36-billion legal charges previously announced in July 2010 for legal cases regarding Avandia, Paxil, and the company’s former manufacturing site in Cidra, Puerto Rico.
Since July 2010, GSK says it has continued to receive a “substantial” number of new product liability cases regarding Avandia in the US. The $3.4-billion estimate stems from the company’s assessment of the additional cases and an estimate of likely future claims.
“We recognize that this is a significant charge, but we believe the approach we are taking to resolve long-standing legal matters is in the company’s best interests,” P.D. Villarreal, senior vice-president of global litigation at GSK, explained in a statement. “We have closed out a number of major cases over the last year and we remain determined to do all we can to reduce our litigation risk.”
The European Medicines Agency recommended that Avandia-once GSK’s biggest grossing blockbuster-be removed from the EU market in September 2010 because of cardiovascular safety concerns. Around the same time, the US pinned stringent restrictions on the product’s use.
Avandia has been associated in studies with increased risk for dangerous health conditions such as heart attack, heart damage, stroke and other associated conditions. Another danger that may occur in patients taking Avandia® is fluid retention or swelling that may lead to or worsen heart failure. People with a history of heart problems should talk to their doctors before starting an Avandia® prescription in order to prevent dangerous cardiovascular side effects including swelling, tiredness and shortness of breath. Because of this dangerous possibility, Avandia® is not recommended for patients with severe heart conditions.
The liver is also an area of potential danger for Avandia® patients. The drug is not recommended for people with active liver disease. It may cause unexpected tiredness, unusually rapid weight gain, dark, yellow urine, yellowing of skin and stomach problems. These symptoms are often associated with liver disease, which is a possible danger of taking Avandia®.