FDA Approves Generic Uloric, Despite Link to Life-Threatening Heart Problems

Published on January 6, 2020 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) has approved another generic version of Uloric, despite evidence linking febuxostat to life-threatening heart problems.

Novadoz Pharmaceuticals, the USA-based sales and marketing unit for India’s MSN Labs, announced it had begun shipping its generic Uloric late last month.

“FDA approval of Febuxostat is the 12th product introduction for the Novadoz label in the first 20 months of our US commercialization,” Novadoz president Seshu Akula said in a statement dated December 31^st. “We expect continued success in 2020 with multiple product approvals, including several in the specialty oncology space.”

Uloric Approval History

Name-brand Uloric is marketed by Takeda Pharmaceuticals. The FDA initially approved the medication in 2009 as a first-line treatment for gout, a painful form of arthritis caused by high levels of uric acid in the blood.

Uloric’s premarket clinical trials did suggest patients taking febuxostat were more likely to experience certain adverse cardiovascular events, including heart attacks, strokes, and heart-related death, compared to those taking another gout drug called allopurinol. As a result, the FDA stipulated that Takeda list these potential Uloric side effects in the “Warnings and Precautions” section of the drug’s label. The company was also directed to conduct a post-market study to better assess the Uloric’s heart risks.

That study was completed in November 2017, and its findings prompted the FDA to launch a Uloric safety review.

“The preliminary results show that overall, febuxostat did not increase the risk of these combined events compared to allopurinol,” the agency said at the time.  “However, when the outcomes were evaluated separately, febuxostat showed an increased risk of heart-related deaths and death from all causes.”

FDA Uloric Warning

Last February, the FDA ordered Takeda to add a new black box warning to the Uloric label reflecting the study’s findings. The agency also demoted febuxostat to second-line treatment status, stipulating that Uloric only be prescribed to patients who haven’t responded to or who are unable to tolerate allopurinol.

According to the agency’s Drug Safety Communication, patients considering febuxostat should let their doctors know if they have a prior history of heart problems or stroke. Those currently taking the medication should seek emergency medical treatment if they experience:

• Chest pain
• Shortness of breath
• Rapid or irregular heartbeat
• Numbness or weakness on one side of your body
• Dizziness
• Trouble talking
• Sudden severe headache

Patients concerned about Uloric heart risks should not stop taking febuxostat without first speaking with their doctor, as doing so could cause their gout to worsen.

Novadoz Pharmaceuticals’ febuxostat is the second generic version of Uloric to come to market since the FDA ordered the black box warning. Last July, the agency approved another generic febuxostat product marketed by India-based Alembic Pharmaceuticals.