The Food and Drug Administration (FDA) recently released a safety statement regarding the Takeda drug Uloric, generic febuxostat. The warning comes after receiving the preliminary results from a 6,000-patient safety trial that found the drug increases the risk of heart disease-related deaths as compared to another medicine used to treat gout, Zyloprim (allopurinol). The FDA recommends that physicians carefully weigh the risks against benefits before prescribing Uloric.

Uloric and Gout

Gout is a type of arthritis that causes acute, often severe pain in joints. Most commonly, attacks of gout occur in the big toe and can be intensely painful and sudden. The cause of this kind of flare up is an accumulation of uric acid crystals in the joint. This happens when there is an excess of uric acid in the blood. Uric acid is a natural result of the breakdown of foods, but certain foods can produce more uric acid, and this excess amount may not be filtered out effectively by the kidneys. The result is the formation of painful crystals in joints.

Uloric, made by Takeda Pharmaceuticals, was developed to reduce levels of uric acid in people with gout. The drug works by blocking the metabolism of purines, which are broken down to produce uric acid and other metabolites. A competing drug, Zyloprim, treats gout in a similar way.

Safety Clinical Trial for Uloric

The FDA recently issued the safety alert for Uloric because of the results of additional safety testing. Initial clinical trials for the drug indicated that it could increase the risk of cardiovascular events. This finding led to a warning on the Uloric label, but it also spurred additional safety testing. The most recent trial included 6,000 patients with gout. Each patient was given either Uloric or Zyloprim.

The results of the trial indicated that Uloric did not increase specific heart-related events, like heart attack, as compared to Zyloprim. The results did show, however, that when compared to the alternative, use of Uloric did increase the risk of death in patients overall and from heart-related causes.

Currently, Uloric includes warnings that it may increase cardiovascular events and that it may cause serious liver impairment, even fatal liver failure. Now, the addition of the increased risk of death compared to another drug, means that Uloric will come with more warnings. The FDA is not recalling the drug, only issuing the safety statement as a warning to doctors and patients.

The current recommendation from the FDA regarding the new safety findings is that doctors use great care and consideration when prescribing Uloric over other drugs, like Zyloprim. Patients are urged to talk to their doctors about concerns, but to not stop using Uloric without their doctor’s direction and guidance. Doctors and patients are also encouraged to report any adverse events associated with Uloric through the FDA Adverse Event Reporting Program. This will help the FDA to track any side effects and serious adverse reactions from Uloric, which may lead to further studies, warnings or actions against the drug.