Patients with gout and clinicians who treat the disease should be aware of a recent Food and Drug Administration Safety Announcement regarding the drug Febuxostat.

Commonly known as Uloric or Adenuric, Febuxostat was initially developed by a Japanese pharmaceutical company in the late 1990s. Its primary use is to treat chronic gout and a related condition known as “hyperuricemia,” which refers to excessive uric acid production within the body.

The FDA alert, which was released in November, mentions that a clinical safety trial found that Febuxostat is more dangerous than Allopurinol, which is a different type of medication on the market that used to treat gout. What’s so dangerous about it? There was an increased risk of heart-related death associated with Febuxostat. Allopurinol inhibits the enzyme Xanthine oxidase, which generates reactive oxygen in the body. Febuxostat decreases the levels of uric acid circulating in a patient’s blood.

According to the study, researchers compared a total of 6,000 patients who took Allopurinol to patients taking Febuxostat and monitored them for cardiac problems, such as heart attacks, strokes, and heart-related deaths. The higher risk of heart-associated deaths and all-cause deaths linked to Febuxostat warranted the increased attention from the FDA.

The regulatory body will continue to monitor the situation and provide updates as more concrete information becomes available. Physicians who have observed any cardiac-related complications following the administration of Febuxostat are advised to contact the FDA with further details.

As research continues, additional data is essential and can provide a more complete picture of what is happening and why. The study process was initiated years ago (starting in 2009, when the drug was first approved). Since then, physicians have been able to prescribe the medication and receive feedback from patients.

Aside from its potential cardiac complications, Febuxostat has other, milder side effects as well. Like other medications, it’s possible to be allergic to the ingredients in the drug. Possible side effects include fever, swollen glands, chest pain, neurological deficits (i.e. weakness or blurry vision), joint pain, and stomach discomfort. Patients with gout can opt for other medications (i.e. Allopurinol) following consultation with their physicians. Moreover, preventive measures have also been helpful. Purine rich foods can spark gout attacks, so it’s important to avoid organ meats, mushrooms, and alcohol to the extent possible.