Summary Safety Review - ULORIC (febuxostat) - Assessing the Potential Risk of Heart Failure
Review decision
A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Issued: 2016-04-01
Product
Uloric (febuxostat)
Potential Safety Issue
Heart Failure
Overview
Use in Canada
- Febuxostat has been marketed in Canada under the brand name Uloric since 2010.
- Febuxostat is an oral medication used for the treatment of gout (a painful inflammation of joints caused when uric acid forms hard crystals in the joint) to lower uric acid levels in the blood.
- At the time of the review, there were approximately 82,000 prescriptions each year for Uloric in Canada.
Safety Review Findings
- At the time of the review, no cases of heart failure linked with febuxostat use were reported in Canada.
- As of March 01, 2015, there were 32 Individual Case Safety Reports of heart failure suspected of being linked with febuxostat use in the World Health Organization (WHO) Global Individual Case Safety Reports Database System, of which 8 were linked with deaths.a
- Scientific literature reports that hyperuricemia (high levels of uric acid in the blood) and gout are linked with an increased risk of cardiovascular disease which affects the interpretation of cardiovascular side effects in this population. Researchers also mentioned that a contribution from febuxostat causing or worsening heart failure could not be ruled out.
Conclusions and actions
- Based on all of the information reviewed, Health Canada has asked the manufacturer of Uloric (febuxostat) to include a statement regarding the potential increased risk of heart failure in patients with pre-existing cardiovascular disease and/or risk factors in the Canadian prescribing information document.
- Health Canada will continue to monitor side effect information for febuxostat, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action, if and when any new health risks are identified.
Additional information
The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of this drug both in Canada and internationally.
For additional information, contact the Marketed Health Products Directorate.
Footnotes
- World Health Otranization (WHO) adverse reaction information provided by: The WHO collaborating Centre for International Drug Monitoring. This information is not homogeneous with respect to the sources of the information or the likelihood that the pharmaceutical product caused the suspected adverse reaction. Also, this information does not represent the opinion of the WHO.