The U.S. Food and Drug administration approved the gout medication known as Uloric in 2009. During its pre-market clinical trials, researchers noted an increase in Uloric cardiac related deaths and other heart issues with those taking the drug.

This increase was measured against a control group taking allopurinol, a gout medication marketed under the brand names of Zyloprim and Aloprim.

The incidence of Uloric cardiac related deaths, non-fatal heart attacks and strokes, as well as cardiac ischemia—a condition where there is a decrease in blood supply to the heart muscle—was so significant that the FDA required the drug’s manufacturer to conduct an additional post market clinical study.

The requested post market clinical safety study involved over 6,000 gout sufferers who were taking either Uloric or allopurinol. Takeda, the Chigago area-based manufacturer of Uloric, publicized the data that came out of this study recently.

The data showed higher risks of Uloric cardiac related deaths, survivable cardiac arrests, and strokes. Cardiac ischemia also showed up in the data and often required immediate emergency surgery to correct in those experiencing the phenomena.

Gout and Its Treatment

Gout is a type of arthritis that usually affects at least one joint in the body. It is most recognizable by localized redness, swelling, and pain, and often is seen in the joints of the lower extremities such as the great toe.

Its diagnosis is confirmed by laboratory tests which show an elevated amount of uric acid in the bloodstream. It is these uric acid crystals that settle in the associated joint and cause the pain.

Gout has been associated in the past with “high living,” in that a diet rich in red meats, shellfish, and alcohol are strong contributing factors in its development. It often tends to co-occur in patients that are obese and suffer from type-2 diabetes or heart disease. Drugs to treat gout help to lower uric acid in the blood.

Post Market Study Spurs FDA Action

The release of the data indicating higher risks of Uloric cardiac related deaths and other heart symptomology and conditions while taking Uloric spurred the FDA to release an urgent drug safety communication on Nov. 15, 2017.

The communication encouraged medication professionals to seriously consider the data when determining the best course of treatment for new patients with gout. It also encouraged them to take the information into consideration when evaluating whether a current patient should remain on Uloric or be switched to an alternative medication.

Uloric has had a warning on its label from its market introduction in 2009 about the chance of cardiac problems, so physicians should have already done this evaluation with current patients on the drug. The release of the new study results underscores this necessity.

The urgent FDA communication also is addressed to the public, but does not encourage current takers of Uloric to remove the drug from their treatment regimen without a serious conversation with their prescribing physician.