Other safety alerts
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| Canada: Uloric (febuxostat): Increased risk of cardiovascular fatal outcomes |
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Health Canada announces that results from a post-market clinical study (the CARES trial) found an increased risk of cardiovascular (CV) fatal outcomes in patients with gout and known CV disease treated with Uloric, when compared to those treated with allopurinol.
Previously, Uloric was indicated to lower serum uric acid levels in patients with gout (a first-line therapy). Based on the results of the CARES study, Uloric is now indicated to lower serum uric acid levels in patients with gout who have an inadequate response or intolerance to allopurinol, or for whom treatment with allopurinol is inappropriate (a second-line therapy).
The Uloric indication was revised to enhance the safe use of Uloric based on evidence identified in a recently completed, randomized, double-blind, allopurinol-controlled CARES study. This study was conducted to evaluate the CV risk of Uloric in patients with gout who had a history of major CV disease, cerebrovascular disease, or diabetes mellitus with micro- and/or macrovascular disease. The study compared the risk of major adverse CV events between patients treated with Uloric (N=3098) and allopurinol-treated patients (N=3092). There was a higher rate of CV death in patients treated with Uloric (134 CV deaths of 3098) compared to patients treated with allopurinol (100 CV deaths of 3092). All-cause mortality was higher in the Uloric group (243 deaths of 3098) than the allopurinol group (199 deaths of 3092) due to a higher rate of CV deaths. Sudden cardiac death was the most common cause of adjudicated CV deaths in the Uloric group (83 of 3098; 2.7%) as compared to the allopurinol group (56 of 3092; 1.8%).
Further to narrowing the Uloric indication for use, additional changes were made to the Uloric Canadian Product Monograph (CPM) to further mitigate the risk identified in the CARES study. The increased risk of CV fatal outcomes has been included in the Serious Warnings and Precautions Box of the Uloric CPM. The Warnings and Precautions, Adverse Reactions, Clinical Trials and Consumer Information sections in the CPM have also been updated in relation to this issue.
Before taking Uloric, patients should tell their healthcare professional if they have a history of heart problems or stroke. Patients taking Uloric who experience signs or symptoms of CV disease such as chest pain, dizziness, fainting or feeling light-headed, rapid or irregular heartbeat, trouble talking, sudden blurry vision, or severe headache should stop taking the medication and tell their healthcare professional immediately.
Healthcare professionals are advised to:
- Use Uloric only in adult patients with gout who have an inadequate response or intolerance to allopurinol, or for whom treatment with allopurinol is inappropriate.
- Not recommend Uloric treatment in patients with ischemic heart disease or congestive heart failure.
- Monitor for signs and symptoms of myocardial infarction, stroke and cardiac failure in patients who are taking Uloric.
- Inform patients about the CV risk with Uloric and advise them to seek medical attention immediately if they experience the symptoms listed above.
Health Canada has worked with Takeda Canada Inc. to update the CPM for Uloric.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../71511a-eng.php
In Hong Kong, there are 2 registered pharmaceutical products containing febuxostat, namely Feburic Tablets 80mg (HK-61185) and Feburic Tablets 120mg (HK-61186). Both products are registered by Astellas Pharma Hong Kong Company Limited, and are prescription-only medicines. So far, the Department of Health (DH) has received one case of adverse drug reaction related to febuxostat, but this case is not related to death. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 16 Nov 2017, with the latest update posted on 2 Oct 2019. Letters to inform local healthcare professionals were issued by the DH on 22 Feb 2019. In Jun 2019, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and noted that the package insert of the local products had included relevant safety information. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Tuesday, Nov 5, 2019
Issued at HKT 15:00
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