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Febuxostat (Adenuric) tablets

Safety advisory – increased risk of death in gout patients with a history of major cardiovascular disease

1 October 2019

Consumers and health professionals are advised that an increased risk of death has been observed in a study of gout patients with pre-existing major cardiovascular disease who were treated with febuxostat tablets compared to allopurinol tablets (another medicine used to treat gout).

Febuxostat, which is marketed in Australia under the brand name Adenuric, is a prescription medicine used to treat adults with chronic gout.

The Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES) study was a long-term study involving more than 6000 patients with gout and pre-existing major cardiovascular disease. It compared the cardiovascular safety of febuxostat with allopurinol. The study found that, while the risk of combined cardiovascular events was not increased compared to allopurinol, patients taking febuxostat had a higher risk of death, and specifically heart-related death, compared to patients who took the other medicine.

The Product Information (PI) for febuxostat previously included a warning that it was not recommended for patients with ischaemic heart disease or congestive heart failure. In response to the CARES study, this has been strengthened to include all patients with pre-existing major cardiovascular disease. To highlight the seriousness of this precaution, a boxed warning has been added to both the febuxostat PI and Consumer Medicine Information (CMI).

Information for consumers

If you take febuxostat (Adenuric) tablets and have or have had heart disease, heart failure, a heart attack or a stroke, speak to your doctor. Do not stop taking your medicine unless advised to do so by your doctor.

Seek urgent medical attention if you experience any of the following symptoms:

  • chest pain
  • shortness of breath
  • trouble breathing
  • dizziness
  • fainting
  • feeling lightheaded
  • rapid or irregular heartbeat
  • numbness or weakness in one side of your body
  • slurring of speech
  • sudden blurry vision
  • sudden severe headache.

If you have any questions or concerns about this issue, speak to your doctor.

Information for health professionals

The sponsor of febuxostat (Adenuric) tablets, A Menarini Australia, has recently written to health professionals to provide information about this issue.

Please note that febuxostat is not recommended for use in gout patients with pre-existing major cardiovascular disease, including ischaemic heart disease, cardiac failure, stroke or transient ischaemic attack, peripheral vascular disease or diabetes mellitus with evidence of microvascular or macrovascular disease.

Please consider patients’ cardiovascular risk factors before initiating febuxostat.

If you are treating patients with febuxostat, monitor for and counsel them on the signs and symptoms of myocardial infarction, stroke and congestive cardiac failure and educate them on what they should do if they experience them.

If you have any questions or concerns about this issue, contact A Menarini Australia on 1800 644 542 or at patient.safety@menariniapac.com.

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.