(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.