Dec. 7, 2015
Reject Gout Treatment, Public Citizen Tells the FDA
The U.S. Food and Drug Administration (FDA) should reject the advice of its advisory committee and not approve lesinurad, a medication to treat gout, Public Citizen said today in a letter to the agency.
Public Citizen maintains that multiple FDA-approved gout medications already are 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 is associated with very troubling safety concerns, the most significant being compelling evidence of kidney toxicity and serious cardiac adverse events.
“FDA approval of lesinurad — even with reliance on warnings in the product labeling, a risk evaluation and mitigation strategy, and postmarket safety studies — would be a reckless approach and would not be in the interests of public health,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group.