Summary Safety Review - ULORIC (febuxostat) - Assessing the Potential Risk of Heart Failure
April 01, 2016
Potential Safety Issue
- Uloric (febuxostat) is a drug used to treat gout, a painful form of arthritis.
- During routine monitoring of information received from the manufacturer, several international cases of heart failure suspected of being linked with the use of febuxostat were found. A safety review was carried out by Health Canada to further assess the issue.
- Health Canada has asked the manufacturer to update the Canadian prescribing information for febuxostat to include the risk of heart failure in patients that have cardiovascular disease and/or other risk factors.
Health Canada carried out a safety review after finding several international cases of heart failure suspected of being linked with the use of Uloric (febuxostat). Heart failure, also known as congestive heart failure, occurs when the heart muscle is not able to pump blood properly. Health problems, such as narrowed arteries in the heart (coronary artery disease) or high blood pressure, gradually leave the heart unable to pump efficiently. Signs of heart failure may include shortness of breath, fatigue and weakness, swelling (edema) in the legs, ankles and feet and rapid or irregular heartbeat.
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.Footnote 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.
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.
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