FDA Issues Warning About Gout Medication: Did the Sponsor Suppress Information?

FDA Warning

The FDA posted an urgent message on its website on February 21, 2019: “The FDA has concluded there is an increased risk of death with Uloric (febuxostat) compared to another gout medicine, allopurinol. This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric.”
The FDA reports that people talking Uloric for the treatment of gout may face an increased risk of:

  • Cardiac event-related death
  • Non-deadly heart attack
  • Non-deadly stroke
  • Unstable angina
  • Death

It is important to mention that there has been a whistleblower action against Takeda in regards to Uloric. The Japanese pharma company has been accused of suppressing information about the serious side effects of Uloric, which was approved by the FDA under the condition that the manufacturer conduct post-marketing clinical trials to compare the rates of cardiovascular events linked Uloric and allopurinol.