The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a warning for Menarini's gout treatment febuxostat, brand name Adenuric.
The Agency warn that an increased risk of cardiovascular death and all-cause mortality seen in a clinical trial in patients with a history of major cardiovascular disease.
The advice given is:
'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 and a history of major cardiovascular disease show a higher risk for cardiovascular-related death and for all-cause mortality in patients assigned to febuxostat than in those assigned to allopurinol.'
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MHRA Advice for healthcare professionals:
- 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
- note the clinical guidelines for gout (see below), which recommend treatment with febuxostat only when allopurinol is not tolerated or contraindicated
- report suspected adverse drug reactions to febuxostat on a Yellow Card
About Adenuric (source EMA)
Adenuric is used to treat adults with long-term hyperuricaemia (high levels of uric acid or ‘urate’ in the blood). Hyperuricaemia can lead to urate crystals forming and building up in the joints and the kidneys. When this happens in the joints and causes pain, it is known as ‘gout’. Adenuric is used in patients who already have signs of a build-up of crystals, including gouty arthritis (pain and inflammation in the joints) or tophi (‘stones’, larger deposits of urate crystals that can cause joint and bone damage).
Adenuric is also used to treat and prevent high levels of uric acid in the blood in adults with blood cancers who are on chemotherapy and at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells causing a sudden rise of uric acid in the blood which can cause damage to the kidneys).
The medicine can only be obtained with a prescription.
The active substance in Adenuric, febuxostat, reduces the formation of uric acid. It works by blocking an enzyme called xanthine oxidase, which is needed to make uric acid in the body. By reducing the production of uric acid, Adenuric can reduce levels of uric acid in the blood and keep them low, stopping crystals from building up. This can reduce the symptoms of gout. Keeping uric acid levels low for long enough can also shrink tophi. In patients who are on chemotherapy a reduction in uric acid levels is expected to reduce the risk of tumour lysis syndrome.
Adenuric was first made available in the EU in 2008. It is manufactured by Menarini.
The Medicines and Healthcare products Regulatory Agency (MHRA)
European Medicines Agency website page for Adenuric
Links available in full article
MHRA announcement about Adenuric
Reporting of suspected adverse reactions
Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
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About Articular gout
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About Myocardial infarction