Uloric Benefits Do Not Outweigh Heart Risks For Most Patients, FDA Panel Determines

A panel of drug safety experts suggests that side effects of Uloric use for treatment of gout may cause some users to face serious cardiovascular risks, outweighing the potential benefits for most patients. 

The FDA’s Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee reviewed safety data and recent study data on the gout drug Uloric (febuxostat), voting 19 to 2 on Monday to advise the agency to make the drug a mostly second-line therapy for a select population of patients.

The panel warned that the benefits of Uloric only outweigh the risks for a small group of patients, indicating that the drug should be considered too risky for most other patients.

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Uloric is used to help lower uric acid in patients with gout. However, post-market clinical trials indicate patients who take Uloric face an increased risk of suffering death from cardiovascular problems, such as heart attack or stroke.

For that reason, the FDA panel recommended Uloric be used as second-line treatment for general gout patients, and only as a first-line treatment in specific cases.

Zyloprim, known generically as allopurinol, is also prescribed to lower uric acid in gout patients. However, the drug is often incorrectly dosed by doctors, making it ineffective in some cases. Thus, doctors turn to other treatments, such as Uloric. Additionally, some patients may not tolerate Zyloprim well, or experience serious skin reactions.

For those patients, Uloric is a better option, despite the cardiovascular risks, the panel determined. However, for most patients Uloric should only be offered as a second-line treatment for gout. This would mean it would only be prescribed by doctors when patients cannot take the first preferred drug, Zyloprim, or if they don’t tolerate the drug well, or if the drug doesn’t work well for them.

Another recommendation was to add a black box warning to Uloric. A black box warning is the most serious type of warning that can be placed on an approved drug and indicates there are serious side effects that may occur as a result of taking the drug. However, some committee members said even that is not enough to adequately warn most patients of Uloric heart risks.

Committee members also suggested implementing a Risk Evaluation and Mitigation Strategy (REMS) which would call for the drug to be kept at a centralized pharmacy, making it available only if the doctor and the patient both gave informed consent acknowledging the increased risk of cardiovascular death.

The FDA is not required to follow the recommendation of the advisory committee, but the agency typically does.

Panel members noted that if the data from the recent clinical trial was available in 2008, when the drug was first approved, Uloric wouldn’t have been approved at all. The clinical trial was begun after approval as a post-market condition.

Concerns regarding the gout drug were raised after the FDA issued a safety warning in 2017. The warning indicated the agency was investigating deaths linked to Uloric, including cardiovascular deaths and deaths related to interactions with other drugs, including bone marrow failure, severe bleeding and kidney failure.


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