California county sues GSK over Avandia
A California county has accused GlaxoSmithKline of falsely advertising its diabetes drug Avandia, aiming to recoup the cost of the drug for hospitals, clinics, and counties across the state. It appears to be the first government lawsuit over the diabetes med, which has been the subject of a debate over its potential links to heart attacks and strokes, Pharmalot notes.
The lawsuit estimates that Avandia may have caused 60,000 to 200,000 heart attacks, strokes and cardiovascular deaths in the U.S. from 1999 to 2006, according to the San Jose Mercury News. Over about the same period of time, Santa Clara County spent $2 million on the drug for indigent patients, and, the lawsuit alleges, absorbed the cost of treating heart patients whose CV troubles could have been avoided if the drugmaker had warned of the risks.
Experts have been jousting over Avandia for almost three years now, ever since a meta-analysis found a big increase in the risk of heart attacks in patients who used the diabetes med. The FDA had an expert advisory panel consider the evidence, and it concluded that while the drug did boost the risk of heart failure, the data on heart-attack and stroke risks was inconclusive.
With more data now available--and a U.S. Senate report accusing GSK of downplaying the drug's risks--the agency is revisiting Avandia sometime this summer. Will more lawsuits hit the courts in the meantime?