A new Uloric FDA alert warns patients taking the gout medication about the risks of heart-related death. Those patients already taking the drug should be aware of the dangers, especially if they already face a higher risk of heart-related issues.

A recent study that led to the Uloric FDA alert shows that those patients taking the medication are at an increased risk of developing problems that could lead to heart-related death. The medication was linked to an increase in death when compared with other brands of gout medications.

Other severe risks exist with the Uloric medication, but the Uloric FDA alert specifically addresses heart-related death. Some of the other side effects that impact Uloric patients include non-deadly strokes, non-deadly heart attacks and cardiac ischemia. Cardiac ischemia can lead to a need for surgery.

The Uloric FDA alert came about as a result of studies reviewed by the government agency. Two different drug safety communications were released under the Uloric FDA alert in November 2017.

The second risk shared in the Uloric FDA alert related to the agency’s commitment to evaluate death from all causes in addition to heart-related deaths caused by Uloric.

The Uloric FDA alert was issued following the manufacturer’s release of information in a clinical trial indicating that patients faced significant risks taking the drug. This was in comparison with the gout medication allopurinol.

More than 6,000 patients were included in the study that led to the Uloric FDA alert. The trial indicated that patients experienced a range of serious side effects due to taking Uloric, the most serious of which was a heightened risk of heart-related death.

Uloric received initial FDA approval in 2009. Those initial clinical trials for the drug showed a risk of many different side effects at that time, but additional trials showed that the risks may be more serious than expected.

Because of the concerns shared in the initial clinical trial, the manufacturer was required to complete an additional study regarding the risks.

Uloric is prescribed to patients who have a diagnosis of gout. Gout is arthritis that happens when uric acid builds up inside the patient’s body. This can lead to swelling, severe pain and redness in at least one joint. Gout medications like Uloric work by breaking down the uric acid levels in the blood.

More knowledge about severe Uloric side effects came about from a whistleblower in 2012. That person worked as a safety consultant who alleged that the drugmaker went out of their way to hide information about the negative side effects from the government during the initial trial approval.

The whistleblower lawsuit that preceded the Uloric FDA alert claimed that the manufacturer hid fatal side effects from the U.S. government during the initial approval process, meaning that patients didn’t have the right information to make an informed decision about taking the medication at all. The whistleblower further alleged that Takeda did not report that Uloric was also tied to severe bleeding, bone marrow failure and kidney failure.