On Nov. 15, 2017, the U.S. Food and Drug Administration (FDA) warned the medical professional community and public that use of febuxostat and cardiovascular risk of death or critical heart events may be connected.

Uloric, the brand name under which febuxostat is marketed, is a medication used to treat gout. Gout is a form of arthritis caused by a build-up of uric acid in the body and characterized by redness and swelling in one or more joints in the body—typically seen in the joint of the great toe.

Recent alerts regarding use of febuxostat and cardiovascular risk of death or the development of serious heart issues were the result of a release of a post-market clinical trial demanded by the FDA.

This trial was a required follow-up after initial premarket studies indicated that use of febuxostat and cardiovascular risk of experiencing heart attack, fatal or non-fatal, was shown to be slightly elevated.

Uloric was approved and commercially released by the FDA in 2009 despite this information regarding febuxostat and cardiovascular risk. The results of the first few clinical studies, however, did earn it a warning label and further review.

The latest clinical trial involved 6,000 patients, half of whom were taking Uloric’s treatment competitor—allopurinol—as a control group. Allopurinol is marketed under the trade names of Zyloprim and Aloprim.

Takeda Pharmaceuticals, a Chicago-area company, is the developer and manufacturer of Uloric. The FDA required this corporation to oversee this latest trial and evaluate additional statistics it gleaned regarding the use of febuxostat and cardiovascular risk.

The risk of experiencing death from a sudden heart attack while taking the medication was still found to be higher than normal as was dying from all causes while under treatment as compared to allopurinol.

Because of this recent study, the FDA intends to undergo further evaluation of Uloric as it relates to patient death from both cardiac events and non-cardiac causes.

In the meantime, the safety communication was intended to inform current and potential patients and alert doctors to fully evaluate gout sufferers for additional cardiovascular risks prior to prescribing the drug.

Takeda Pharmaceuticals and Other Uloric History

In 2012, a former safety consultant to the Takeda Pharmaceutical Co., filed a whistleblower lawsuit on behalf of the federal government. The meat of the lawsuit alleged that Uloric’s developer obscured potential side effects of Uloric from the federal government.

According to the plaintiff, the purported motive in obscuring these problems was to be able to promote the drug as superior to alopurinol and make it the gout drug of choice for physicians prescribing to Medicare and Medicaid patients.

The problem with this concealment was that Uloric was about 50 times more expensive to take daily than the alternative and, according to the plaintiff, resulted in fraud against the public health programs.

Among the issues that were supposedly hidden by Takeda were Uloric-related bone marrow production problems, kidney failure and out-of-control bleeding. The effects of combining other drugs with Uloric were also allegedly suppressed because some of those effects led to fatal outcomes.