A safety announcement was recently made by the U.S. Food and Drug Administration (FDA) reporting that it plans to evaluate increased risk of heart-related death with Uloric (febuxostat), a gout medicine, and all other Uloric side effects.

The safety announcement was made by the FDA on Nov. 15, 2017, and communicated after the federal agency received preliminary results from a safety clinical trial comparing Uloric to another gout medicine, allopurinol, sold under the brand names Aloprim and Zyloprim.

According to the FDA, the agency required Uloric’s manufacture, Takeda Pharmaceuticals, to conduct the safety study when the drug was approved in 2009. They are currently waiting on final results from Takeda and state that they will update the public accordingly.

So far, the preliminary results from the study discovered that Uloric side effects include risk of heart-related deaths, as death increased in addition to other deaths from other causes.

Reported Uloric side effects include non-deadly strokes, non-deadly heart attacks, and cardiac ischemia.

Uloric Side Effects FDA Safety Announcement

According to the FDA, Uloric was approved to treat a type of arthritis condition known as gout.

Gout occurs when there is an increase or build-up of uric acid and it is characterized by severe pain, redness, and tenderness in joints. Uloric works by lowering uric acid levels in the blood, the FDA says.

According to the Mayo Clinic, patients describe the development and advance of gout as happening rather suddenly. Some patients with gout describe waking up in the middle of the night feeling as if their toe is on fire.

The affected joint tends to feel hot, tender, and swollen. Symptoms and signs of gout, which occur suddenly and often at night, include lingering discomfort that lasts a few days to a few weeks, inflammation and redness in the affected joints, and intense joint pain.

The FDA states that Uloric already carries a Warning and Precaution label, as cardiovascular Uloric side effects were already observed in clinical trials conducted before the drug’s approval.

The clinical trial showed an increased rate of heart related Uloric side effects in patients taking the drug in comparison to taking allopurinol. The Uloric side effects included problems such as strokes, heart attacks, and other heart-related deaths, the FDA claims.

The preliminary results from the more current clinic study were just recently announced. This clinical trial included a study using 6,000 patients with a gout condition. The study tested patients taking either allopurinol or Uloric.

The Uloric side effects discovered was a combination of non-deadly heart attacks, non-deadly stroke, the inadequate supply of blood to the heart requiring immediate surgery, and heart-related death.

According to the FDA, although there was no increase in risk with Uloric compared to allopurinol, Uloric did show an “increased risk of heart-related deaths and death from all causes.”

According to the FDA, “[h]ealth care professionals should consider this safety information when deciding whether to prescribe or continue on febuxostat. Patients should talk to your health care professionals if you have any questions or concerns.”