The FDA has issued a safety warning regarding the increased risk of Uloric heart-related death.

Uloric is a gout medicine from drug maker Takeda Pharmaceuticals, which operates a Chicago-area subsidiary. Uloric was the first gout medication approved by the FDA in 40 years when it was introduced in 2009.

Takeda conducted a safety trial that was ordered by the FDA in 2009. The trial examined gout patients who received either Uloric (febuxostat) or allopurinol. Patients had a higher risk of Uloric heart-related death than those who took allopurinol.

The FDA has asked Takeda to conduct further studies of Uloric because patients who took Uloric appeared to have an increased risk of death from all causes. In addition, serious side effects include non-deadly heart attacks, non-deadly strokes, and cardiac ischemia that necessitated emergency surgical intervention.

Uloric Heart-related Death Allegedly Hidden

A former Takeda safety consultant alleges in a whistleblower lawsuit that the company hid Uloric’s serious adverse effects and possibly dangerous drug interactions from doctors, consumers and the FDA.

Not only was a Uloric heart-related death possible, but other potentially dangerous and deadly side effects could include:

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

In an effort to push Uloric on the market before any competitors could beat them to it, Takeda allegedly chose to hide Uloric’s potential adverse side effects. Further, alleged the lawsuit, Uloric can cause potentially fatal interactions with some medications, including warfarin, Imuran, methadone and digoxin.

Because Uloric and methadone share the same metabolizing enzyme, the combination of using the two drugs causes the enzyme to remain active longer than it should. This extended active state has led to at least one known fatal overdose.

What is Gout?

Gout is an inflammatory arthritis caused by the build up of too much uric acid in the blood. The excess uric acid crystallizes, settles into the joints and causes severe pain, swelling and redness. The inflamed joint can feel warmer than the rest of the body, mimicking an infection.

Nearly four percent of American adults suffer from gout attacks, and for unknown reasons, most of those patients are men. Patients with chronic gout can experience joint damage that affects their mobility.

Uloric’s website indicates the most common side effect of starting the medication is a gout flare up, which is most likely due to the dissolving crystals within the joints. The flare up will subside once the uric acid level reduces to normal levels. If a patient experiences subsequent flare ups while on the medication, a doctor’s advice should be sought immediately.

Patients who believe they have suffered any heart-related illness while taking Uloric should speak with their doctor to avoid Uloric heart-related death. Patients also could speak to a lawyer regarding opportunities for legal recourse.