Drug Safety Update: Etoricoxib (Arcoxia) - revised dose recommendation for rheumatoid arthritis and ankylosing spondylitis

Prescribing information for etoricoxib has been updated to introduce a lower recommended dose of 60 mg od for patients with rheumatoid arthritis or ankylosing spondylitis. In patients with insufficient relief from symptoms, an increased dose of 90 mg od may improve efficacy.

The dose has been revised following an EU-wide review in 2008 of the benefits and risks of etoricoxib. Further clinical trials assessing the efficacy and safety of etoricoxib 60 mg once daily for the treatment of rheumatoid arthritis and ankylosing spondylitis were performed which included a comparison with etoricoxib 90 mg. Results showed evidence that the 60-mg dose is effective in rheumatoid arthritis and ankylosing spondylitis.

 

Separately, healthcare professionals have also been sent a letter alerting them to this information.