UPDATE: (March 2019) – Last month the U.S. Food and Drug Administration (“FDA”) ordered its strongest safety warning (i.e., “Black-Box Warning”) to be applied to Uloric‘s drug label to advise physicians about the increased risk of cardiovascular-related death associated with the drug. There has been no recall of the drug, however.
“The U.S. Food and Drug Administration (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.
As a result, we are updating the Uloric prescribing information to require a Boxed Warning, our most prominent warning, and a new patient Medication Guide. We are also limiting the approved use of Uloric to certain patients who are not treated effectively or experience severe side effects with allopurinol.”
Read the related February 2019 article “Gout Drug Raises Death Risk”, authored by Senor Associate Editor for MedPage Today, Crystal Phend, here.
If you or a loved one have used Uloric and experienced a Heart Attack or Stroke, contact us online or call 1-866-252-3535 for a free consultation.
UPDATE: (June 2018) – Consumer advocacy group Public Citizen has called on the FDA to recall the drug Uloric. “There is ‘overwhelming evidence that the serious cardiovascular harms of [Uloric] outweigh any purported clinical benefit,” the petition states. Leaving it on the market ensures “further preventable harm” to patients.
(Nov. 15, 2017) – The U.S. Food and Drug Administration (“FDA”) has issued a safety communication warning the public that preliminary results from a clinical trial assessing the safety of Uloric, a drug prescribed for the chronic management of hyperuricemia in patients with gout, showed an increased risk of cardiovascular-related events, including death.
Uloric is manufactured by Takeda and was first approved for use in 2009.
The labeling for Uloric presently does contain warnings about adverse cardiovascular events as the result of studies conduced before the drug was approved. However, deeper analysis of the data from those studies indicate the risk of heart attack or stroke may be much higher than originally thought. Once the final data from the safety study are received, the FDA plans to comprehensively evaluate and update the public with any new information.
Our firm is watching this situation closely. If you or a loved one have used Uloric and experienced a Heart Attack or Stroke, contact us online or call 1-866-252-3535 for a free consultation.
Patients 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.