The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2016 (PDF).
This issue contains updated advice introducing a lower recommended dose of etoricoxib (Arcoxia®) at 60 mg daily for patients with rheumatoid arthritis or ankylosing spondylitis. A European review in 2008 requested further clinical trials to compare the safety and efficacy for a 60mg daily dose with the previously recommended daily dose of 90mg. These trials have established that 60mg is an effective dose although some patients may still require the 90mg dose. As such the following recommendations are now made:
- the lowest effective daily dose should be used, and the need for treatment should be regularly reassessed to reduce cardiovascular and other risks
- 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
There is also a summary of letters sent to healthcare professionals in September including the planned withdrawal of retigabine (Trobalt®) and the interaction between levonorgestrel-containing emergency hormonal contraception and hepatic enzyme inducers reported in Drug Safety Update last month.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.