Despite Drug Safety Problem Of Cardiovascular Mortality, Benefits Might Be Seen To Outweigh Risks For Select Gout Patients
Uloric (febuxostat) was approved by the FDA in 2009 for the chronic management of hyperuricemia in patients with gout. Now, in 2019, there may be an Uloric recall.
In more detail, one condition of the 2009 Uloric drug approval was that a postmarketing safety study be conducted by Takeda Pharmaceuticals America, Inc.
The FDA-required postmarketing safety trial was called Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Comorbidities (CARES) trial. In March 2018 it was announced that this CARES trial found that Uloric was inexplicably linked to more cardiac deaths than was allopurinol, the mainstay drug for in patients with gout and cardiovascular disease.
On January 10, 2019 the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee panelists discussed the potential biological mechanisms behind cardiovascular (CV) events associated with Uloric use.
As background, an FDA Drug Safety Communication was issued in November 2017 based on a preliminary analysis of CARES, and the Public Citizen consumer advocacy group filed a Citizen Petition in June 2018 requesting that Uloric be removed from the market, i.e., drug recall.
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From this January 11, 2019 MedPage Today report, "Make Uloric Second-Line for Gout, FDA Advisors Say", we get this report of the two Advisory Committees meeting:
Members voted 19 to 2 (with one abstention) that a patient population exists for whom [the Uloric (febuxostat)] benefit-to-risk profile is favorable in its current indication as first-line treatment for hyperuricemia in gout, despite a known link to cardiac deaths.
This includes individuals who have had a serious skin reaction to or otherwise "absolutely don't tolerate" allopurinol, the mainstay xanthine oxidase inhibitor for uric acid reduction, suggested Steven Nissen, MD, of the Cleveland Clinic and a panelist at the meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
"For everybody else, for the general population with gout, I would say that in those people the benefits do not outweigh the risk," he cautioned....
"If a [Risk Evaluation and Mitigation Strategy (REMS)] can't be developed, I would favor withdrawal," Nissen responded. Other panelists called for boxed warnings but stopped short of calling for [Uloric (febuxostat)] to be withdrawn because of cardiovascular mortality, the mechanism for which remains unclear.
As we have pointed out previously, the FDA is not required to follow the advice of its Advisory Committees, but it usually does.
We will watch to see what the FDA decides to do in this instance -- which might be an Uloric recall, a so-called "Black-Box Warning" on the Uloric drug label, a REMS for Uloric, or a statement that Uloric should only be used by select gout patients.
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