Consumer Group Contends That The Evidence Of Harmful Uloric Side Effects Outweighs Any Real Benefit To Patients
The FDA should order Takeda Pharmaceuticals to immediately withdraw from the market its gout drug Uloric (febuxostat), according to a citizen petition submitted to the drug safety regulatory agency on June 21, 2018.
The consumer advocacy group Public Citizen asserts that a Uloric drug recall is necessary following results of a large postmarketing study that showed higher rates of fatal cardiovascular (CV) events and all-cause mortality in patients taking the drug. More exactly, it is the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidity (CARES) clinical trial results which are pointed out by the June 2018 Public Citizen petition letter.
Essentially, this document concerning Uloric drug safety issues that was sent to the FDA by Public Citizen contends that there is "overwhelming evidence that the serious cardiovascular harms of [Uloric (febuxostat)] outweigh any purported clinical benefit".
Uloric was initially approved by the FDA in 2009.
According to a June 21, 2018 press release issued by Public Citizen, "FDA Should Pull Twice-Rejected Gout Medication Off the Market":
In the decade since [the 2009 FDA approval, Uloric] “has been aggressively marketed and prescribed to at least hundreds of thousands of patients … who were unaware of the potential dangers,” Public Citizen’s petition states. Takeda reported $1.9 billion in U.S. sales of febuxostat from fiscal years 2012 through 2017. For the one-year period ending in June 2015, there were 1.3 million U.S. prescriptions for Uloric, making it the 46th most prescribed brand-name medication in the U.S at the time.
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More details about this Uloric recall request submitted to the FDA are set forth in Public Citizen's June 21, 2018 Citizen Petition. Here are two such excerpts:
(1) On November 15, 2017, the FDA issued a drug safety communication alerting the public that preliminary results from the FDA-mandated post-market randomized controlled trial to assess the safety of [Uloric (febuxostat)] showed an increased risk of cardiovascular-related death and all-cause death with [Uloric (febuxostat)] compared with allopurinol. The agency recommended that “[h]ealth care professionals should consider this safety information when deciding whether to prescribe or continue patients on [Uloric (febuxostat)].”
On March 12, 2018, White et al. published the results of the postmarket clinical trial in The New England Journal of Medicine online, which demonstrated non-inferiority in terms of the primary composite cardiovascular outcomes endpoint but higher all-cause and cardiovascular mortality in [Uloric (febuxostat)]-exposed subjects than in allopurinol-exposed subjects. [footnotes omitted]
(2) The results of the FDA-mandated postmarket trial now provide additional high-quality evidence of a causal link between treatment with [Uloric (febuxostat)] and increased risk of all-cause death and cardiovascular death. The FDA almost certainly would have denied approval of [Uloric (febuxostat)] if data from this postmarket trial had been available at the time of the initial NDA submission, and the appropriate course of action now is obvious. We therefore request that the FDA remove from the market all medications containing [Uloric (febuxostat)].
From a June 27, 2018 news report, "Public Citizen Calls on FDA to Pull Gout Drug Due to CV Risk", published by Medscape, presents the drug company's response this Uloric citizen petition filing:
Kara Hoeger, corporate communications officer for Takeda Pharmaceuticals, said the company is aware of the petition and "declines to comment on it; the FDA will respond to Public Citizen's petition."
"Through presentation at [the American College of Cardiology (ACC)] and publication in [The New England Journal of Medicine (NEJM), we've been proactive in sharing CARES with the medical community as well as FDA — first notifying them following the initial data analysis in October," she said. "We've submitted the complete study data to the FDA and are working with them to conduct a comprehensive review of this data."
So will the FDA recall Uloric, as requested by Public Citizen in June 2018? This remains uncertain, but some drug safety observers are somewhat pessimistic, as seen in this relevant part of a recent article, "FDA Repays Industry by Rushing Risky Drugs to Market", written by Caroline Chen for ProPublica:
Even when post-marketing studies belatedly confirm that drugs are dangerous, the agency doesn’t always pull them off the market. Consider Uloric, the gout treatment. Even though it consistently lowered uric acid blood levels, the FDA rejected it in 2005 and again in 2006, because trials linked it to cardiovascular problems. But a third study by the manufacturer, Takeda Pharmaceutical of Osaka, Japan, didn’t raise the same alarms. So the agency decided in 2009 to let the drug on the market, while asking Takeda for a post-marketing study of 6,000 patients to clarify the drug’s cardiovascular effects.
Takeda took more than eight years to complete the study. It found that patients on Uloric had a 22 percent higher risk of death from any cause and a 34 percent higher risk of heart-related deaths than patients taking allopurinol, a generic alternative. The FDA issued a public alert in November 2017, sharing the results of the trial, but left Uloric on the market.
Our law firm is currently investigating possible Uloric drug injury lawsuits against Takeda for which we are offering free case evaluations for patients and their family.
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