- Medicines and Healthcare products Regulatory Agency
- 17 October 2016
- Therapeutic area:
- Pain management and palliation and Rheumatology
Prescribing information has been updated to introduce a lower recommended dose of 60 mg daily for patients with rheumatoid arthritis or ankylosing spondylitis.
Advice for healthcare professionals:
- 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
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.
Further information on these risks is described in section 4.4 of the Summary of Product Characteristics.
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.
Letter sent to healthcare professionals in September 2016
Article citation: Drug Safety Update volume 10 issue 3, October 2016: 1.
Published: 17 October 2016