WASHINGTON – The popular type 2 diabetes drug Avandia should be removed from the U.S. market, according to testimony delivered today by Public Citizen before a Food and Drug Administration (FDA) advisory committee panel investigating the medication.
Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, testified about the risks of Avandia (rosiglitazone), detailing pre-approval and post-approval evidence of cardiac toxicity, liver toxicity and anemia. Wolfe also discussed post-approval evidence of increased bone fractures in women and damage to patients' vision associated with the drug.
"Does the overall risk-benefit profile of Avandia support its continued marketing in the United States?" said Wolfe. "The answer is clearly no."
According to Wolfe's testimony, in FDA adverse reaction reports filed since marketing began for the drug in 1999 through the end of last year, there was a 15.2 times higher adjusted rate of heart failure reported with Avandia than for the older diabetes drug Glucotrol. The adjusted rate of liver toxicity with Avandia was 9.5 times higher, and 14.8 times higher for liver failure.
In addition, the adjusted rate of post-approval adverse reaction reports for anemia in patients was 13.3 times higher for Avandia than with Glucotrol. In patients already damaged by heart failure or other cardiac risks associated with the drug, the addition of anemia could significantly worsen their clinical condition, Wolfe warned. Wolfe also cited in his testimony a recently completed study finding statistically significant increases in bone fractures in women using Avandia compared to those using another diabetes drug.
Vision impairment, a major complication of diabetes, is also made worse by Avandia, Wolfe said. A mechanism related to heart failure and fluid accumulation has produced macular edema – a swelling in the retina – in many patients, causing usually reversible damage to vision. The adjusted reporting rate for macular edema was 35.3 times higher for Avandia than for Glucotrol.
"There is no evidence of any uniquely beneficial clinical outcome for Avandia and growing evidence of unique risks in multiple organ systems," concluded Wolfe. "If Avandia were up for approval today, based on what is now known, it would be summarily rejected. There should not be a double standard for removing it from the market."
Because of the dangers associated with the drug that are not present in older, safer diabetes medications, Public Citizen is preparing a petition to the FDA to remove Avandia from the market.