On July 24, 2013, The Wall Street Journal reported that the British drug company GlaxoSmithKline (GSK) agreed to pay $229 million to resolve lawsuits in the United States. Claims were brought against GSK for intentionally misrepresenting the efficacy and safety profile of the diabetes drug Avandia (rosiglitazone).
There has been controversy surrounding the risk of heart attack and heart-related death in Avandia patients since 2007, when the drug was issued a boxed warning for such adverse events. Boxed warnings are alerts that the FDA may require pharmaceutical companies to include in the prescribing information of drugs if the medication is associated with a significant risk or serious adverse event. The availability of Avandia has since been restricted.
Last year, GSK paid $90 million over U.S. consumer-protection claims for Avandia. The states of Kentucky, Louisiana, Maryland, Mississippi, New Mexico, South Carolina, Utah and West Virginia elected to decline involvement of the 2012 settlement, and will be the recipients of the newly appointed $229 million sum. GSK stated that the settlement was agreed upon in order to circumvent lengthy trials and litigation, and that the agreement should not be taken as admittance of liability.
Avandia (rosiglitazone) is an orally-administered type 2 diabetes drug manufactured by GlaxoSmithKline plc. First approved by the FDA on May 25, 1999, Avandia lowers blood sugar by increasing the sensitivity of the liver, fat, and muscle cells to insulin. Avandia quickly became the top-selling diabetes pill in the world, but concerns over potential heart problems resulting from Avandia began to emerge in 2007. The FDA announced in May 2011 that Avandia would be pulled from pharmacy shelves beginning in November 2011, due to the cardiovascular risks associated with the drug.
Using FAERS data (from 11/01/1997 to 08/27/2012), aggregated and standardized by the AdverseEvent RxFilter process, we identified 49,822 serious adverse events which listed Avandia as a suspect drug. Of these reports, 39,084 listed Avandia as the primary suspect.
The most commonly reported side effects were myocardial infarction (heart attack), congestive cardiac failure, and cerebrovascular accident (stroke). We identified 20,786 hospitalizations and 6,657 patient deaths where Avandia was indicated as the primary suspect.