Gout Drug Associated with Cardiovascular Risk

The gout drug Uloric (febuxostat) appears to have a higher rate of heart-related death when compared with another gout medication, according to a new FDA safety alert.

Following Uloric’s approval in 2009, the FDA required its manufacturer, Takeda Pharmaceuticals, to conduct a postmarket safety trial because clinical trials indicated that patients treated with Uloric had a higher rate of heart-related issues – such as heart attacks, strokes and heart-related deaths – compared to patients taking Zyloprim or Aloprim (allopurinol).

The warnings and precautions section of Uloric’s label notes the risk of cardiovascular events.

The safety trial enrolled 6,000 gout patients treated with either febuxostat or allopurinol. Preliminary results showed there was a higher risk of heart-related death and death from all types of causes in the febuxostat group.

The FDA is not taking any direct action at this time. However, it is urging doctors to consider the results before prescribing Uloric or continuing patients on the drug.


Jonathan Block

Jonathan Block

Jonathan Block is an associate editor at BioCentury, which provides news and information about the biotechnology and pharmaceutical industries. Prior to joining BioCentury in 2019, Jonathan worked for MedShadow as content editor. He has been an editor and writer for multiple pharmaceutical, health and medical publications, including The Pink Sheet, Modern Healthcare, Health Plan Week and Psychiatry Advisor. He holds a BA from Tufts University and is earning an MPH with a focus on health policy from the CUNY Graduate School of Public Health & Health Policy.


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