The dangers of Uloric cardiovascular risks have prompted a petition requesting that the Food and Drug Administration remove this dangerous product from the market.

Public Citizen, a consumer advocacy organization operating as a nonprofit, discovered research so alarming about Uloric cardiovascular risks that they requested that this drug be pulled from the market.

The gout medication febuxostat, also known as Uloric, allegedly causes serious and sometimes fatal cardiovascular risks, according to a press release shared by the organization. While the drug helps with uric acid, Uloric cardiovascular risks may affect those patients who take the drug for gout.

Uloric Dangers

This drug was originally approved in 2009 by the FDA for the management of hyperuricemia in patients diagnosed with gout. According to the information shared about Uloric cardiovascular risks by the nonprofit, however, there exists overwhelming evidence that the cardiovascular dangers outweigh any alleged clinical benefit.

The group added that allowing it to stay on the U.S. market means that other people may suffer from Uloric cardiovascular risks and could even suffer fatal side effects. Prior to the approval of Uloric, according to the organization, there was strong evidence suggesting that the medication increased the chances of adverse cardiovascular events and death.

Public Citizen shared that the agency should have demanded additional clinical trials to further verify the severity of Uloric cardiovascular risks. Data from clinical trials indicated a high rate of stroke, heart related death and myocardial infarction linked with the drug.

Uloric Study Findings

As a result of those Uloric cardiovascular risk findings, the FDA demanded an additional safety trial be completed after approval and marketing. That study, concluded in 2017, involved more than 6,000 patients who were treated with this drug. The primary outcome was a combination of non-deadly stroke, non-deadly myocardial infarction, and heart related death.

These Uloric cardiovascular risks should not only be shared with the public but should prompt the FDA to remove the drug from the market, according to the nonprofit group urging for these next steps. Those preliminary results indicated that Febuxostat was connected with a higher risk of heart related deaths and all cause mortality when every outcome was indicated individually.

The study did not show a higher risk of combined events. The New England Journal of Medicine published the Uloric cardiovascular risks results in March of 2018. Public Citizen says that the findings show that after 32 months, those patients who were treated with this drug were significantly more likely to die of cardiovascular effects than any other cause compared to those received Allopurinol.

A class action investigation is currently looking for people who have been harmed by Uloric cardiovascular risks and who might have grounds to pursue a lawsuit. Some patients who developed heart problems after taking the drug have already come forward with legal claims. Filing an adverse event report with the FDA could be the first step for a person who already suffered, but a lawsuit might be the only way for an injured patient to get the compensation he or she needs.