Last month, the U.S. Food and Drug Administration (FDA) decided to mandate a black box warning on the gout drug known as febuxostat after concluding that it presented an increased risk of cardiovascular injury and death. Febuxostat is the active ingredient in the gout medication known as Uloric, manufactured by the Takeda Pharmaceutical Company – one of the largest pharmaceutical producers in the world. The FDA also updated its patient medication guide for Uloric to include a warning that heart-related death is a possible serious side effect of the drug.
The FDA’s conclusion came after a required postmarket safety study confirmed there was a higher rate of cardiovascular mortality with the drug when compared to another gout drug called allopurinol. During preapproval clinic trials for Uloric, a correlation between the use of Uloric and an increased rate of heart attack, stroke, and heart-related deaths was seen, prompting the FDA to require the postmarket safety study.
The postmarket study 6,190 patients diagnosed with gout who were taking either febuxostat or allopurinol, a different gout medication. On March 12, 2018, the results of the postmarket study were published in the New England Journal of Medicine, confirming a significant connection between febuxostat and an increased threat of fatal cardiovascular complications compared to allopurinol.
After the postmarket study’s publication, Public Citizen – a nonprofit organization that advocates for consumer rights and safety – petitioned the FDA to ban febuxostat from the market.
“The FDA almost certainly would have denied approval of febuxostat if data from this postmarket trial had been available at the time of the initial submission,” Michael Carome, MD, director of Public Citizen’s Health Research Group, stated in a press release. “The only justifiable course of action to prevent further cardiovascular deaths is obvious: This medication must be removed from the U.S. market immediately.”
Under Kentucky law, the manufacturer of a pharmaceutical product can be held strictly liable for injuries caused by a product that presents an unreasonable risk of harm to patients. A medication is considered to be unreasonably dangerous if an ordinary prudent manufacturer, fully apprised of the medication’s risks, would decide against introducing it to the consumer market.[1] Such a determination would require a jury to balance the risks and harmful side effects of Uloric against its benefits.
It is more likely that Takeda could avoid liability for deaths caused by Uloric if febuxostat offered more effective benefits than allopurinol. But, if the gross benefits of both drugs were equal, the increased cardiovascular mortality rate of febuxostat would indicate a net detriment to users.
Kentucky law also says that drug manufacturers have a duty to include adequate warnings about the risks and harmful side effects of pharmaceuticals.[2] Here, warnings about cardiovascular risks were initially included when Uloric was placed in the market in 2009. However, the fact that the FDA updated its patient medication guide and labeling requirements strongly suggests that prior warnings were not adequate.
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