Uloric-Related Acute Kidney Injury: Researchers Find A Significantly Higher Reporting Odds Ratio In Women Compared To Men
(Posted by Tom Lamb at DrugInjuryWatch.com)
Uloric (febuxostat) is a popular urate-lowering therapy (ULT) used as a first-line treatment for gout, as is the generic drug allopurinol. According to a recent medical journal article, acute renal failure (ARF), or kidney failure, is reported as an adverse drug reaction 5.7 times more frequently with Uloric than with other ULT gout drugs, and 3.3 times more often with allopurinol. This is some important new Uloric drug safety information from our perspective.
This article, "Acute Kidney Injury Associated With Febuxostat and Allopurinol -- A Post-Marketing Study", was published by the Arthritis Research & Therapy medical journal in November 2019. The new Uloric drug safety information presented by medical researchers in that article is summarized in this excerpt:
In the present study, we detected a disproportionality signal for [acute renal failure (ARF)] and the ULTs [Uloric (febuxostat)] and allopurinol. The presence of this signal was confirmed in a variety of sensitivity analyses (i.e., when [Uloric (febuxostat)] and allopurinol were the only suspected drugs, when we used other [Xanthine oxydase (XO)] inhibitors as the comparator or when known nephrotoxic drugs were excluded).
The purpose of studying the disproportionality of spontaneous [individual case safety reports (ICSRs)] is to generate pharmacovigilance alerts concerning unknown or underestimated [adverse drug reactions (ADRs)]. Until the present case/non-case study, the risk of [acute kidney injury (AKI)] associated with allopurinol and [Uloric (febuxostat)] had been underestimated. In fact, renal and urinary tract disorders were reported (albeit not in detail) during an extended phase III [Uloric (febuxostat)] clinical trial . However, AKI has not been mentioned for other phase III trials. Moreover, to the best of our knowledge, no phase IV studies have addressed this topic for the two studied ULTs. [Footnotes omitted.]
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The November 2019 medical journal article goes on to point out why this new Uloric drug safety information may be more of a concern for women than men:
For both drugs, the [reporting odds ratio (ROR)] was higher in women than in men, respectively 11.60 [9.74–13.82] vs. 3.14 [2.69–3.67] for [Uloric (febuxostat)] and 4.45 [4.04–4.91] vs. 2.29 [2.11–2.50] for allopurinol.
We will continue to monitor the FDA and review medical journals for any significant developments concerning this new Uloric drug safety information about acute kidney injury (AKI) and acute renal failure (ARF).
Our law firm is investigating possible Uloric lawsuits where patients have suffered Uloric side effects.
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