Two Gout Drugs Removed From Market
If you have gout and rely on lesinurad (
Zurampic
) or lesinurad plus allopurinol (
Duzallo
), you’ll need to check with your doctor to find an alternative for managing the pain, swelling, redness and other symptoms of your disease. That’s because these two drugs have been pulled from the market.
Ironwood Pharmaceuticals discontinued sales of these two gout drugs in February 2019. The patient savings programs for both medications were discontinued effective December 31, 2018.
“This is a business decision and is not related to any efficacy, safety or clinical concerns with lesinurad,” the company said when it made the announcement.
The Food and Drug Administration (FDA) had cited some safety concerns when it approved lesinurad in 2015. It required a black box warning about the risk of acute renal failure and mandated a clinical trial to investigate those risks.
Low Demand, High Cost
Donald Miller, Pharm.D, a professor of Pharmacy Practice at the School of Pharmacy at North Dakota State University in Fargo, says a number of factors likely went into the decision. He explains that there are two main kinds of medications for gout: drugs that increase the excretion of uric acid through the urine (called uricosurics) and those that reduce production of uric acid in the body (called xanthine oxidase inhibitors, or XOIs). But without special testing, it isn’t clear which patients need to excrete more and which need to produce less uric acid. And because uricosuric drugs like lesinurad should not be used for people who overproduce uric acid because the medication could create uric acid kidney stones, “99 percent of physicians simply put all gout patients on a xanthine oxidase inhibitor,” says Miller.
Xanthine oxidase inhibitors include allopurinol ( Aloprim, Zyloprim ) and febuxostat ( Uloric ); uricosurics include lesinurad and probenecid ( Benemid, Probalan ).
Cost is another factor. Lesinurad was not available as a generic and was more expensive than the alternative uricosuric, probenecid, as well as allopurinol.
“Due to the above concern, as well as its cost compared to probenecid and allopurinol, lesinurad simply never established a market for itself,” says Miller.
A Loss for Some Patients
Rheumatologists say the loss of these drugs is unfortunate because most who turned to them likely did so because they were resistant to the maximum therapeutic or tolerated dose of allopurinol.
“Allopurinol is most common drug used to lower serum urate in people with gout; [it] is well-tolerated and usually very effective, if used in the therapeutic doses [up] to 800 mg/day. However, in some cases people do not respond or cannot tolerate higher doses, which was one of the indications of lesinurad,” explains Jasvinder Singh, MD, director of the Gout Clinic at the University of Alabama Health Sciences Foundation in Birmingham. “It’s unfortunate, since this treatment option was being used in people who were refractory [resistant] to max tolerated doses of allopurinol.”
So what should you do if these were the medications you relied on to manage your gout symptoms?
Ironwood pharmaceuticals did not respond to a request asking for comment, but its website advises patients who were taking either medication to consult with their doctor before stopping treatment and to work with a medical professional to find a new option.
Dr. Singh says there are other medication possibilities to explore. “These patients would consider combining allopurinol plus febuxostat, pegloticase infusions, or will be left with sub-optimally treated gout,” he explains.
The company says patients with questions can contact Ironwood via the Contact Us Webform ( https://contactus.irwdpi.com/ ) or call the Ironwood Contact Center at 1-844-374-4793.
Ironwood Pharmaceuticals discontinued sales of these two gout drugs in February 2019. The patient savings programs for both medications were discontinued effective December 31, 2018.
“This is a business decision and is not related to any efficacy, safety or clinical concerns with lesinurad,” the company said when it made the announcement.
The Food and Drug Administration (FDA) had cited some safety concerns when it approved lesinurad in 2015. It required a black box warning about the risk of acute renal failure and mandated a clinical trial to investigate those risks.
Low Demand, High Cost
Donald Miller, Pharm.D, a professor of Pharmacy Practice at the School of Pharmacy at North Dakota State University in Fargo, says a number of factors likely went into the decision. He explains that there are two main kinds of medications for gout: drugs that increase the excretion of uric acid through the urine (called uricosurics) and those that reduce production of uric acid in the body (called xanthine oxidase inhibitors, or XOIs). But without special testing, it isn’t clear which patients need to excrete more and which need to produce less uric acid. And because uricosuric drugs like lesinurad should not be used for people who overproduce uric acid because the medication could create uric acid kidney stones, “99 percent of physicians simply put all gout patients on a xanthine oxidase inhibitor,” says Miller.
Xanthine oxidase inhibitors include allopurinol ( Aloprim, Zyloprim ) and febuxostat ( Uloric ); uricosurics include lesinurad and probenecid ( Benemid, Probalan ).
Cost is another factor. Lesinurad was not available as a generic and was more expensive than the alternative uricosuric, probenecid, as well as allopurinol.
“Due to the above concern, as well as its cost compared to probenecid and allopurinol, lesinurad simply never established a market for itself,” says Miller.
A Loss for Some Patients
Rheumatologists say the loss of these drugs is unfortunate because most who turned to them likely did so because they were resistant to the maximum therapeutic or tolerated dose of allopurinol.
“Allopurinol is most common drug used to lower serum urate in people with gout; [it] is well-tolerated and usually very effective, if used in the therapeutic doses [up] to 800 mg/day. However, in some cases people do not respond or cannot tolerate higher doses, which was one of the indications of lesinurad,” explains Jasvinder Singh, MD, director of the Gout Clinic at the University of Alabama Health Sciences Foundation in Birmingham. “It’s unfortunate, since this treatment option was being used in people who were refractory [resistant] to max tolerated doses of allopurinol.”
So what should you do if these were the medications you relied on to manage your gout symptoms?
Ironwood pharmaceuticals did not respond to a request asking for comment, but its website advises patients who were taking either medication to consult with their doctor before stopping treatment and to work with a medical professional to find a new option.
Dr. Singh says there are other medication possibilities to explore. “These patients would consider combining allopurinol plus febuxostat, pegloticase infusions, or will be left with sub-optimally treated gout,” he explains.
The company says patients with questions can contact Ironwood via the Contact Us Webform ( https://contactus.irwdpi.com/ ) or call the Ironwood Contact Center at 1-844-374-4793.
