Studies suggest the gout medication Uloric may be one among many cardiac ischemia causes.

The Food and Drug Administration (FDA) issued a communication warning that Uloric (febuxostat) may increase the risk of cardiac ischemia and heart-related death. The FDA based its communication on the results of clinical studies that suggest Uloric may be among cardiac ischemia causes. 

Uloric manufacturer Takeda Pharmaceuticals conducted the clinical trial that the FDA ordered in 2009. The trial compared the effects of Uloric with those of patients taking allopurinol, which is a gout medication sold under the brand names of Zyloprim and Aloprim. Patients taking Uloric experienced serious side effects that included non-deadly heart attacks and non-deadly strokes.

In the clinical study conducted by Takeda, Uloric patients had a higher risk of sudden, heart-related death and of death from all causes than those who were on allopurinol.

Cardiac Ischemia Causes

Cardiac ischemia causes heart attacks or an irregular heartbeat that can lead to heart failure. Initial symptoms might include chest pain, often referred to as angina by doctors. Other symptoms of cardiac ischemia include:

• Pain in the neck, jaw, shoulder or arm
• Shortness of breath upon exercise
• Sweating for no apparent reason
• Upset stomach or vomiting
• Fatigue

Patients with cardiac ischemia might need to undergo a procedure to save their lives. Steps that might be taken include:

• Angioplasty and stenting: A catheter is inserted into the problematic portion of the artery that has become too narrow. At that point, a wire with a balloon inflates the artery to widen it enough to allow a small wire stent to be inserted, which will serve to keep the artery open.
• Coronary artery bypass surgery: A surgeon takes a blood vessel from another part of the patient’s body and places it in a way that re-routes the blood around the blocked coronary artery.
• Enhanced external counterpulsation: This is a non-invasive treatment that involves wrapping cuffs around the legs that are inflated and deflated with air. The pressure on the blood vessels might improve blood flow to the heart, even though the narrowed pathways.

In some patients who have no symptoms, cardiac ischemia causes sudden death.

Uloric may also be linked to other possibly deadly side effects, including:

• Other heart problems
• Severe bleeding
• Kidney failure
• Bone marrow failure
• Liver failure
• Psychotic behavior
• Severe rashes

Takeda has been accused of hiding Uloric’s negative side effects in an effort to place the drug on the market before any competitors could do so. When it was FDA-approved in 2009, Uloric was the first gout medication approved in nearly 40 years.

A former Takeda safety consultant filed a whistleblower lawsuit alleging Takeda knew of the serious adverse effects of the drug but hid the dangers from the FDA, doctors, and consumers.

Approximately four percent of the U.S. population suffer from gout attacks. Gout is inflammatory arthritis due to an accumulation of too much uric acid in the blood. When the uric acid crystallizes, the crystals settle into the joints, causing severe pain, swelling, and redness.