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Caution is required if prescribing febuxostat in patients with pre-existing major cardiovascular disease, particularly, in those with evidence of high urate crystal and tophi burden or those initiating urate-lowering therapy.
As with all products, the MHRA will keep its safety under close review.
Reminder on risk of serious and fatal toxicity in overdose.
Avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease (for example, myocardial infarction, stroke, or unstable angina), unless no other therapy options are appropriate. Findings from a phase 4 clinical study (the CARES study) in patients with gout...
Summary of the latest safety advice for medicines and medical device users
MHRA continues to identify cases of herbal medicines, particularly traditional Chinese medicines, which contain illegal and toxic Aristolochia or aristolochic acids.
Febuxostat must be stopped immediately if hypersensitivity occurs and must not be re-started in patients who have ever developed a hypersensitivity reaction to febuxostat.
The MHRA’s Interim Executive Director of Science and Research writes in The British Medical Journal on the approval of the UK’s first new UTI antibiotic in nearly 30 years, and the wider challenge of tackling antibiotic resistance.
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