GlaxoSmithKline announced on June 2, 2010, that it settled the first civil lawsuit brought by a diabetes sufferer who claimed he had a heart attack after taking Avandia (rosiglitazone). The drugmaker acknowledged that it still faced hundreds of lawsuits in U.S. federal courts despite widespread reports circulated in May that it had settled a group of other Avandia liability suits.
My colleagues and I have written several times about the growing evidence of the health risks taking Avandia poses to patients already facing serious, lifelong health problems. Avandia use has been linked to signifcant increases in heart attacks, cardiovascular disease, bone fractures and liver damage. The U.S. Food and Drug Administration has required GSK to add strict warnings to Avandia’s label about the potential for severe side effects, and the agency scheduled an advisory committee meeting for this July to consider whether Avandia should remain on the U.S. market.
Regardless of the panel’s and, ultimately, the FDA’s, decision, the millions of people with diabetes who have and may take Avandia do appear to be at risk from the very medication prescribed to help them. While no drug is 100 percent safe for all users at all times, drugmakers and regulators need to act to protect patients when drugs start harming large numbers of users. Offering monetary settlements is one response, but more decisive action might be called for.
EJL