The FDA recently issued a public warning regarding Uloric side effects, stating the gout medication could increase the risk of cardiac related deaths. According to this warning, the FDA is starting an investigation into all deaths potentially related to Uloric side effects.

The FDA issued this warning after reviewing the results of a clinical trial, which compared Uloric side effects to fellow gout treatment medication allopurinol. The clinical trial consisted of over 6,000 gout patients who were either prescribed Uloric or allopurinol, and the results reportedly indicated that Uloric patients faced a higher risk of cardiac death.

According to the results of the trial, Uloric side effects patients suffered included non-fatal heart attacks and stroke, cardiac death, and cardiac ischemia that required emergency surgery. Cardiac ischemia occurs when there is insufficient blood flow to the heart, which can be potentially fatal for the patient.

This clinical study was ordered by the FDA upon the drug’s release in 2009, with Takeda Pharmaceuticals mentioning reports of heart attacks, strokes, and other cardiovascular events on the list of potential Uloric side effects.

The FDA ordered the clinical trials to properly evaluate the risks of these Uloric side effects, with the agency also stating it will be investigating all cardiac deaths potentially linked to the gout medication.

At this time, the FDA is advising prescribing physicians to be cautious when recommending Uloric and to consider alternative treatments.

“Health care professionals should consider this safety information when deciding whether to prescribe or continue patients on febuxostat. [P]atients should talk to your health care professionals if you have any questions or concerns. Do not stop taking your medicine without first consulting with your health care professional,” the FDA stated.

Overview of Uloric Side Effects Concerns

Uloric is a popular gout treatment medication that works by reducing the level of uric acid in the blood, which can cause a painful form of arthritis if it builds up. By reducing the uric acid, the arthritis symptoms can be mitigated and the patients’ everyday lives are not as severely impacted.

While a popular treatment medication for numerous patients, the medical community has become concerned with Uloric side effects being linked to an increased risk of cardiac death. The severity of Uloric side effects had previously gained attention in a 2012 whistleblower lawsuit filed by a former Takeda Pharmaceuticals safety consultant.

According to the lawsuit, Takeda allegedly failed to disclose the fact that patients could suffer serious Uloric side effects when used in conjunction with digoxin, imuran, methadone and warfarin. This information was supposed to be disclosed to Medicare and Medicaid, with the whistleblower stating that some of the interactions had been fatal.

The FDA is currently calling for any doctors and patients that observe serious Uloric side effects, especially cardiovascular complications, to report them to the FDA’s MedWatch adverse event reporting program. The FDA further stated that it will continue to update the published with relevant information regarding Uloric side effects.