FDA Approved Uloric with Known Safety Concerns


By Sandra Dalton, Staff Writer

Takeda sought approval for Uloric (febuxostat) in 2005 and 2006 but was denied due to concerns of heart risks and risk of death. In 2009, the U.S. Food and Drug Administration (FDA) gave in to the drug maker and approved the gout medication for sale on the U.S. market, with the condition that Takeda would conduct post-marketing safety studies to be completed by January 31, 2015.

2017 FDA Warning

In November 2017, the FDA issued a drug safety alert for Uloric. The alert was based on preliminary findings of the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) trial. With the drug on the market for over eight years, the FDA says the preliminary results did indeed show and elevated risk of heart-related death when taking Uloric as compared to taking allopurinol for gout.

The alert advised doctors to consider the risk when prescribing or continuing patients on Uloric. The agency chose to wait for the final results of the trial to take further action. No label change was required. No black box warning was added.

2018 Study Results Are In…

In August 2018, the FDA announced that it had received the final results from the CARES trial, and that it would review the results, convene a committee meeting to talk about the results and the review, and get back with us (the public) after the meeting.

2019 FDA Issues Black Box Warning and Limits Approval

February 2019 rolls around and the FDA finally requires a black box warning on Uloric and limits its approved use of the drug to “certain patients who are not treated effectively or experience severe side effects with allopurinol.” The agency says it made the decision based on the results of the CARES trial. A black box warning, or simply “boxed warning”, is the FDA’s strictest warning and is reserved for drugs and devices that can cause serious or fatal side effects.

This is a decade after the drug was approved. Takeda got 10 good years of sales while unsuspecting patients got to spend 10 years serving as guinea pigs for a drug that had been rejected twice before approval because of potential risks, only to discover that yes, the risks are confirmed, the drug is unsafe.

What kind of sales? According to a 2018 Public Citizen petition to ban the dangerous drug, $1.9 billion in the U.S. from 2012 through 2017 alone.

If you believe that you or a loved one has been harmed by Uloric, you can learn more about your rights and how you can recover damages for your losses by contacting an experienced personal injury attorney who represents clients in pharmaceutical injury cases.

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