The Medicines and Healthcare products Regulatory Agency (MHRA) advised that prescribing information of etoricoxib (Arcoxia) has been updated to introduce a lower recommended dose of 60 mg daily for patients with rheumatoid arthritis or ankylosing spondylitis.
Etoricoxib belongs to the selective COX-2 inhibitor class of drugs and may be associated with an increased risk of coronary and cerebrovascular thrombotic events, heart failure, hypertension, and oedema (compared with placebo and some non-steroidal anti-inflammatory drugs). Other important risks to consider with etoricoxib are effects on the gastrointestinal system, particularly those of perforation, ulceration, or bleeding.
Following an EU-wide review in 2008 of the benefits and risks of etoricoxib, the marketing authorisation holder was required to do clinical trials to assess the efficacy and safety of etoricoxib 60 mg once daily for the treatment of rheumatoid arthritis and ankylosing spondylitis including comparison with etoricoxib 90 mg.
From these trials, there is evidence that the 60-mg dose is effective in rheumatoid arthritis and ankylosing spondylitis. However, for some patients, the 90-mg dose will be more efficacious, although prediction of which patients might benefit from the higher dose is not possible.
Therefore, the recommended starting dose for treatment of rheumatoid arthritis or ankylosing spondylitis has been reduced to 60 mg once daily, with the option to increase to a maximum of 90 mg once daily if necessary.
The MHRA advised healthcare professionals of the following:
• the cardiovascular and other important risks of etoricoxib (Arcoxia) may increase with dose and duration of exposure. Therefore, the lowest effective daily dose should be used, and the need for treatment should be regularly reassessed
• the recommended dose is 60 mg once daily
• in patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may improve efficacy
• once the patient is clinically stabilised, down-titration to 60 mg once daily may be appropriate
• in the absence of therapeutic benefit, other treatment options should be considered
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/etoricoxib-arcoxia-revised-dose-recommendation-for-rheumatoid-arthritis-and-ankylosing-spondylitis
In Hong Kong, Arcoxia Tab 30mg (HK-57452), 60mg (HK-51227), 90mg (HK-51225) and 120mg (HK-51226) are pharmaceutical products registered by Merck Sharp & Dohme (Asia) Ltd (MSD), and are prescription only medicines. So far, the Department of Health (DH) has received four cases of adverse drug reactions in connection with etoricoxib, and the cases involved gastrointestinal haemorrhage, rash and aphothous stomatitis, non-specific swelling and hypersensitivity. MSD has submitted application to update the package insert of the products to reduce the recommended dose which is in line with the MHRA announcement, and the application is under evaluation. DH will remain vigilant on any safety update on etoricoxib by other overseas drug regulatory authorities.
Ends/ Wednesday, October 19, 2016
Issued at HKT 15:00
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