The Takeda gout drug Uloric may be linked to catastrophic heart events that may even result in the death of the patient.

The pharmaceutical company reportedly paid for a study which started in 2009 and enrolled 6,190 patients that had been diagnosed with gout and who had a history of heart-related conditions, myocardial infarction, or other cardiovascular compromise.

The aim of the study, known as the CARES study, was to compare the cardiovascular risks of the Takeda gout drug Uloric and another gout drug named allopurinol.

The CARES Study

Slightly over half of the enrolled 6,190 patients stuck with the Takeda gout drug study by participating for close to three years. The remainder dropped off without communication and it is not known whether these patients are currently taking Uloric, allopurinol, or under treatment at all. Some of them may be deceased.

Of those that stayed with the CARES study, half were given the Takeda gout drug Uloric and the other half were given allopurinol. Both drug groups were administered their medication blindly—that is, researchers and patients didn’t know which formulation study participants were taking.

According to the director of the study—Dr. William White—this type of 50/50 breakdown is not a measure of the medications in the real world. In fact, only 7.5 percent of all 8 million U.S. citizens are prescribed the Takeda gout drug Uloric. Allopurinol is still favored by and large by the professional medical community.

This past March at the American College of Cardiology’s Annual Meeting, the data generated from the CARES study was presented. Conclusions based on this data was also published that month in the New England Journal of Medicine.

Dr. White indicated that he too was surprised by the findings regarding cardiovascular risk and the Takeda gout drug Uloric.

According to the post-market CARES study, which the U.S. Food and Drug Administration (FDA) required Takeda to undertake, the Takeda gout drug Uloric seemed to correlate with a 34 percent increase in death from heart-related incidents if there was a medical history of heart disease.

Generally speaking, it is often part and parcel of having this type of arthritis to have higher risk factors for cardiovascular and kidney function problems.

In addition to this finding, the CARES study also uncovered another disturbing reality—a 22 percent higher chance of dying from causes other than cardiovascular while under treatment with Uloric. Both of these reported results are in comparison to allopurinol, which has been successfully used to treat gout since the middle 1960s.

What is Gout?

Gout is a unique form of arthritis in that it primarily attacks just one to two joints that become highly inflamed, reddened, and painful. The joint most commonly affected in the metatarsal joint of the big toe on one side or the other. The joint symptoms are related to crystalline deposits in the joint of uric acid.

High levels of uric acid in the blood is a hallmark of this disease. It can have a genetic component and tends to be diagnosed more commonly in men rather than women. It is associated in popular culture, however, with rich living as a diet high in alcohol, red meats, and seafood are contributing factors.

Were you or a loved one prescribed Uloric and subsequently experienced a serious cardiovascular event during treatment? You may have a legal claim.