Uloric Heart Problems Can Begin As Soon As One Month After Treatment Begins: Study

Most of the Uloric heart problems reported to the FDA were not on the warning label, researchers warn

The findings of a new study indicate Uloric heart problems can appear as soon as a month after beginning treatment with the gout drug.

Uloric (febuxostat) was introduced by Takeda Pharmaceuticals in 2009 as a prescription medication intended to lower the blood uric levels among adults diagnosed with gout.

Amid aggressive marketing, the drug rapidly became a blockbuster treatment in the United States. However, after growing evidence established a link between Uloric and heart risks, the FDA required new warning information to be added to the drug label in 2019, leading to  Uloric lawsuits being pursued by former users of the drug, alleging they may have avoided a heart attack, stroke or other injuries by using a different treatment for gout.

In findings of a new study published in the medical journal China Pharmacy, researchers report that adverse drug events and signals of heart problems like heart disease, heart failure, and even sudden cardiac death can occur within the first 30 days of starting to take the drug.

Researchers looked at data on adverse drug reactions (ADRs) linked to Uloric use reported to the FDA Adverse Event Reporting System from the first quarter of 2009 through the fourth quarter of 2020. Of the total 8,282 adverse drug events reported, 209 involved adverse drug reactions where Uloric was the primary suspected drug.

More than half of the total drug events were already noted on the label, but the signals which were not already on the warning label were mostly related to heart problems, including heart failure, arrhythmia and extrasystoles, the researchers reported. Those who reported heart problems were most likely to be male and over 60 years old.

Most of the cardiac problems occurred within one month of taking the medication, the researchers found.

“Routine attention should be paid to the cardiac safety of febuxostat during medication,” the researchers said, noting that “further evaluation and validation of febuxostat-inducted cardiac ADR signals are still needed.”

Although some critics have called for a Uloric recall to be issued due to the heart risks, the medications has remained on the market, with severe limitations on its approved uses. However, critics and plaintiffs allege that earlier actions could have been taken if the drug maker had not concealed information about the risks associated with their blockbuster drug.