Oct. 23, 2015
Reject Gout Treatment, Public Citizen Tells FDA Advisory Committee
The U.S. Food and Drug Administration’s (FDA) Arthritis Advisory Committee should recommend that the FDA not approve lesinurad, a medication used to treat gout, Dr. Michael Carome, director of Public Citizen’s Health Research Group, said in testimony today.
Carome maintains that there are multiple FDA-approved gout medications already on the market and lesinurad does not offer any major benefits compared to these approved therapies. Clinical trials of lesinurad showed that it provides at best meager benefits, but has very troubling safety concerns, the most significant being compelling evidence of kidney toxicity and serious cardiac adverse events.
“The only reasonable course of action for the FDA is to reject lesinurad,” said Carome. “Allowing this medication on the market, while relying on a warning label and risk management strategies to protect patients, would be reckless.”