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On Feb. 1, 2019, Ironwood Pharmaceuticals ceased marketing its dangerous gout drug lesinurad, which was sold as a single-drug tablet under the brand name ZURAMPIC and a combination tablet that also contained the older first-line gout drug allopurinol under the brand name DUZALLO.[1] Several years ago, Public Citizen's Health Research Group designated lesinurad as Do Not Use because its substantial risks far outweighed its benefits.[2]
In its announcement of the decision to pull...
On Feb. 1, 2019, Ironwood Pharmaceuticals ceased marketing its dangerous gout drug lesinurad, which was sold as a single-drug tablet under the brand name ZURAMPIC and a combination tablet that also contained the older first-line gout drug allopurinol under the brand name DUZALLO.[1] Several years ago, Public Citizen's Health Research Group designated lesinurad as Do Not Use because its substantial risks far outweighed its benefits.[2]
In its announcement of the decision to pull lesinurad from the market, Ironwood included the following boilerplate language that is typical for such notices: "This is a business decision and is not related to any efficacy, safety or clinical concerns with lesinurad."[3] However, the unwillingness of doctors to prescribe lesinurad because of concerns that it offered limited clinical benefits and carried serious risks likely contributed to poor sales of the drug.
Gout is caused by high blood levels of the bodily waste product uric acid. The Food and Drug Administration approved lesinurad in 2015 only for treating gout patients who have not been adequately treated with one of the older gout drugs known as xanthine oxidase inhibitors (XOIs).[4] Allopurinol (LOPURIN, ZYLOPRIM), the oldest XOI, is the first-choice drug for gout. Lesinurad was approved for use only in combination with an XOI.
Preapproval clinical trials demonstrated that lesinurad resulted in only modest reductions in blood uric acid levels compared with a placebo.[5] More importantly, subjects receiving lesinurad fared no better than those receiving a placebo with respect to the frequency of acute gout attacks and the degree of physical disability.
Alongside its minimal benefits, the drug was associated with a number of serious, potentially fatal risks, including acute kidney failure.
If you are taking lesinurad for treatment of gout, you should consult with the prescribing doctor about alternative treatment options.
References
[1] Ironwood. Duzallo and Zurampic. http://www.zurampic.com/. Accessed February 13, 2019.
[2] New gout drug lesinurad (ZURAMPIC) too dangerous. Worst Pills.org. September 2016. /newsletters/view/1053. Accessed February 13, 2019.
[3] Ironwood. Duzallo and Zurampic. http://www.zurampic.com/. Accessed February 13, 2019.
[4] AstraZeneca. Label: lesinurad (ZURAMPIC). December 2015. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207988lbl.pdf. Accessed February 13, 2019.
[5] Food and Drug Administration. Briefing document for the October 23, 2015, meeting of the Arthritis Advisory Committee for NDA 207988: Lesinurad for the proposed indication of treatment of hyperuricemia associated with gout in combination with a xanthine oxidase inhibitor. https://wayback.archive-it.org/7993/20170405205549/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM467942.pdf. Accessed February 13, 2019.
