其 他 安 全 警 示
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| Australia: Febuxostat (Adenuric) tablets: Safety advisory – increased risk of death in gout patients with a history of major cardiovascular disease (English only) |
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The Therapeutic Goods Administration (TGA) is advising consumers and health professionals 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).
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).
Consumers are advised:
- If consumers take febuxostat (Adenuric) tablets and have or have had heart disease, heart failure, a heart attack or a stroke, speak to their doctor. Do not stop taking their medicine unless advised to do so by their doctor.
- Seek urgent medical attention if they 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 the body, slurring of speech, sudden blurry vision, sudden severe headache.
- If they have any questions or concerns about this issue, speak to their doctor.
Health professionals are advised:
- 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 health professionals 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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/alert/febuxostat-adenuric-tablets
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 the United States Food and Drug Administration and the United Kingdom Medicines and Healthcare products Regulatory Agency, and was posted on the Drug Office website on 16 Nov 2017, 22 Feb 2019 and 18 Jul 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/Wednesday, Oct 2, 2019
Issued at HKT 16:00
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