Patients who take the gout medicine Uloric should be aware that Uloric may lead to more incidents of cardiac problems than other gout medicines. The U.S. Food and Drug Administration is concerned about Uloric cardiovascular safety and has required drug makers to conduct an additional safety study.

Uloric, generically known as febuxostat, is a medicine primarily prescribed for gout. Gout is a type of inflammatory arthritis that may develop when there are high levels of uric acid in the blood. When the blood has high levels of uric acid, the patient may experience sudden and intense joint pain because this acid forms painful needle-like crystals in the joints.

Gout can also cause redness and sudden pain. A gout attack, or a spike in uric acid levels, may be triggered by different factors, but it is characterized by inflammation and pain that intensifies over 10-12 hours and may last up to a week.

About 4 percent of American adults suffer from gout amounting to 6 million men and 2 million women.

Uloric was approved in 2009 and is manufactured by Chicago area-based Takeda Pharmaceuticals. According to the FDA, the drug label for febuxostat shows a Warning and Precaution regarding Uloric cardiovascular safety and precautions users regarding heart-related events.

Before it was approved, clinical trials showed that Uloric, when compared with another gout medication (allopurinol), has a higher incidence of cardiovascular events. As a result, the FDA ordered Takeda to complete an additional safety study on their gout medication to assess Uloric cardiovascular safety.

New Uloric Cardiovascular Safety Study Results

The additional safety study was ordered so that the FDA could better understand Uloric cardiovascular safety and the reasons why heart-related events happened more frequently in Uloric patients.

This Uloric cardiovascular safety study was performed with 6,000 patients who either took febuxostat or allopurinol. When febuxostat was compared with allopurinol, another common medication prescribed for gout, the incidence of heart attack, stroke and heart related deaths were greater in Uloric users.

The FDA reports that in both sets of patients, heart-related death, non-deadly heart attack, non-deadly stroke, and a condition of inadequate blood supply to the heart requiring surgery were all reported. “[W]hen the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes,” the FDA report states.

The FDA also suggests, “Patients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional.”

Additionally, “[h]ealth care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat,” the FDA states.

If you or a loved one has experienced gout and is taking Uloric for their condition, it is worth being concerned about Uloric cardiovascular safety. While monetary compensation cannot take away the pain and suffering caused by fatal cardiovascular events, it can help to alleviate the pressures caused by lost wages and medical bills.