The FDA has issued a drug safety communication to alert the public of febuxostat cardiac side effects.

Febuxostat (Uloric) is approved by the FDA to treat gout in adults. Gout is a type of arthritis that happens when naturally occurring uric acid builds up in the body. The buildup of uric acid causes inflammation and intense pain.

Gout symptoms include sudden attacks of redness, swelling and pain in one or more joints. Risk factors for gout include a diet rich in meat and seafood, alcohol consumption, obesity, diabetes, certain medications, recent surgery and a family history of gout.

Pain relievers, NSAIDs and corticosteroids may be prescribed to mitigate gout attack symptoms, while xanthine oxidase inhibitors may be prescribed to prevent gout attacks.

Febuxostat is a xanthine oxidase inhibitor that works by lowering uric acid levels in the blood. Another common xanthine oxidase inhibitors is allopurinol (Aloprim, Lopurin, Zyloprim).

According to febuxostat’s website, possible side effects include nausea, impaired liver function, gout flares, cardiovascular events, and skin reactions. Febuxostat is manufactured by Takeda, a pharmaceutical company with a subsidiary based in the Chicago area.

Febuxostat was approved by the FDA in 2009. Initial clinical trials of the drug showed an increased risk of heart attacks, strokes, and heart-related deaths. Related warnings are included on the label of the drug. Due to these findings, the FDA required Takeda to perform a post-market study after the drug was released.

The FDA issued a safety announcement on Nov. 15, 2017 regarding febuxostat cardiac side effects. A safety trial, ordered by the FDA following initial approval, was conducted in over 6,000 patients with gout treated with febuxostat and allopurinol.

The primary outcome was “a combination of heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring urgent surgery”.

According to the safety announcement, febuxostat showed an increased risk of heart-related deaths and death from all causes. When the final results of the safety study are received from Takeda, the FDA plans to conduct a full review of the data and issue an update.

Febuxostat cardiac side effects were the subject of a whistleblower lawsuit in 2012. A former Takeda safety consultant claimed that Takeda hid important information about negative side effects from the FDA.

Among other allegations, the lawsuit alleged that Takeda failed to reveal that febuxostat could lead to potentially fatal febuxostat cardiac side effects when used with other drugs such as digoxin, imuran, methadone and warfarin. The lawsuit also claimed that Takeda failed to report that febuxostat can cause bone marrow failure, severe bleeding, and kidney failure.

The lawsuit alleged that Takeda made febuxostat cardiac side effects not seem as severe by changing and falsifying documents that were sent to the FDA. The failure to release this information allegedly led to the death of some febuxostat patients.

The plaintiff claimed the actions by Takeda defrauded Medicare and Medicaid because gout patients were diverted from taking allpurinol, which costs 10 cents per day, to taking febuxostat, which costs $5 per day.

If you or a loved one developed unexpected cardiovascular complications while taking febuxostat, legal recourse may be available. Individuals may qualify to file a febuxostat cardiac side effects lawsuit.