Was lesinurad withdrawn from the market in 2019, and what did the FDA say?
Lesinurad (brand name Zurampic) was withdrawn from the U.S. market in 2019. FDA communications tied to the event centered on safety and product availability for treating chronic gout, particularly in patients who do not achieve enough urate lowering with standard urate-lowering therapy. [1][2]
Why was lesinurad pulled in 2019?
The withdrawal followed concerns about the medicine’s risks, especially kidney-related adverse effects, and the availability of alternative urate-lowering strategies. The FDA-linked action in 2019 reflected the manufacturer’s decision to stop marketing the drug in the United States. [1][2]
What does “withdrawn” mean here—does it mean it was unsafe or that it was banned?
In FDA/market terms, “withdrawn from the market” means the product was discontinued for marketing and removed from distribution, not necessarily that an FDA order labeled the drug broadly “banned” or that it was suddenly found to be unsafe for everyone. For lesinurad, the 2019 action was described as a withdrawal/discontinuation tied to the risk-benefit balance and product plan changes rather than an ongoing FDA consumer warning campaign. [1][2]
Is Zurampic still available outside the U.S.?
Availability depends on the country’s regulator and the manufacturer’s continued authorization. The 2019 withdrawal specifically references U.S. market removal; whether supply continued elsewhere is jurisdiction-specific. [1][2]
What should patients do if they were taking lesinurad?
Patients who were on lesinurad should follow their prescriber’s plan for switching to other gout urate-lowering therapies and monitoring. The key practical issue is maintaining urate control while reducing exposure to a product that is no longer marketed in the U.S. [1][2]
Sources
[1] https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
[2] https://www.fda.gov/drugs/drug-safety-and-availability