Uloric heart side effects cause concern; studies say that the gout drug can cause heart problems, and the FDA has warned patients that the drug may not be as safe as previously assumed.

A study compared Uloric to another gout drug, allopurinol, and discovered that Uloric was linked to heart-related deaths and a higher mortality rate in general. The study also found that Uloric heart side effects included other heart problems, including non-deadly heart attacks, cardiac ischemia, and non-deadly strokes.

Many of these conditions can be serious, require immediate medical attention, and can be fatal.

Because of this new information, the FDA issued two Drug Safety Communications on Nov. 15 about the drug. These warnings were made to the public and medical professionals, saying that the drug may not be as safe and effective as previously thought.

The first warning stated that the agency would evaluate the drug’s risk related to heart-related deaths, and the second warning said that the agency would evaluate the drug in relation to its mortality rate from all causes, not just heart-related ones.

The trial on which the FDA based these warnings was a clinical trial that examined over 6,000 gout patients. Patient taking Uloric for gout were compared to those taking another gout drug, allopurinol.

Uloric was approved in 2009. At that point, there was evidence that the drug caused patients an increased risk of heart attacks, strokes, and heart-related deaths. These risks are included on the warning label. However, the FDA was not satisfied with the level of investigation into these risks and required Takeda, the drug’s maker to perform an additional study on the drug’s connection to heart problems after Uloric was released.

According to the FDA, doctors should exercise caution when prescribing the drug, and patients should be fully informed about Uloric side effects.

Uloric Heart Side Effects Whistleblower Lawsuit

It wasn’t just the FDA who was concerned about the health effects of the drug. In 2012, a former Takeda safety consultant filed a whistleblower lawsuit claiming that the company intentionally hid information from the FDA about Uloric heart side effects and the effects of other drugs.

Specifically, the consultant argued that Takeda did not tell the FDA that Uloric could be dangerous when combined with other drugs. Allegedly, when Uloric was combined with drugs like digoxin, imuran, methadone, and warfarin, the drug can be fatal. The whistleblower lawsuit stated that because Takeda did not warn the FDA or the public about the dangers of combining Uloric with other drugs, several Uloric patients died from dangerous drug combinations.

The former safety consultant also alleged that Uloric could result in bone marrow failure, severe bleeding, and kidney failure. He alleged the drug company downplayed the severity of many Uloric side effects, not just the Uloric heart side effects.

According to the Uloric side effects whistleblower lawsuit, Takeda defrauded Medicare and Medicaid by diverting patients from taking cheaper alternatives to the drug to taking Uloric, which can cost many times the amount of other drugs and is allegedly dangerous to human health.