This past spring, data from a large post-market study of the potential cardiovascular side effects of Uloric—known generically as febuxostat—was published in the New England Journal of Medicine. The study followed close to 6,200 gout patients over two years and nine months.

Half of the study group was taking febuxostat and half were taking allopurinol—an alternative treatment for the arthritic condition caused from higher-than-normal levels of uric acid in the blood. The researchers were blinded as to who was taking which line of treatment in the study.

According to an article by FiercePharma, the study’s results indicated general cardiovascular issues to be evenly dispersed among the two drug groups, but the cardiovascular side effects of Uloric more often led to death.

Another alarming finding was that participating patients that died from any cause during the study period were overwhelmingly from the febuxostat group.

The U.S. Food and Drug Administration (FDA) sent out a safety communication in the middle of November 2017 when some of the study’s information was starting to be released. This memo caused a backlash of pressure to remove the drug from the market because of the side effects of Uloric. Many asked why the medication was approved in the first place, putting citizens at risk.

The History of Cardiovascular Side Effects of Uloric

According to the report at FiercePharma, two other attempts to get domestic approval for Uloric in 2005 and 2006 from the FDA were met with rejection prior to it gaining conditional market release from the drug oversight agency in 2009.

The first submission showed clinical trials where a dozen deaths occurred and nine of those from cardiovascular events among Uloric recipients. The allopurinol control group reported no catastrophic cardiovascular events.

At the time of the second submission in 2006, the FDA expressed concerns and the drug’s manufacturer, Takeda Pharmaceuticals, responded by running a second clinic trial. This trial did not yield the same results and no verifiable risk of cardiovascular side effects of Uloric could be determined.

The FDA determined that the best way to handle this discrepancy in results between the two New Drug Applications (NDAs) was to conditionally market febuxostat with the requirement that this very large post-market safety trial be undertaken.

When the drug was conditionally approved, Takeda was required to label the drug with clear warning of the potential cardiovascular side effects of Uloric.

Now that the Results are In

Since the FDA’s safety communication and even more since the publication of the post-market clinical trial data in the New England Journal of Medicine, public pressure has been mounting on the FDA to pull the drug off the market.

A public advocacy group—known as Public Citizen—has recently sent a petition asking febuxostat to no longer be made available commercially.

In this petition, the consumer advocacy group indicates that the side effects of Uloric are more numerous than the benefits it offers and that removing it is the best and sanest decision to make on the part of the American people.