Article date: July 2008
The European Medicines Agency has completed a review of the benefits and risks of 90 mg etoricoxib (Arcoxia▼) in the treatment of rheumatoid arthritis and ankylosing spondylitis. The Agency’s Committee for Medicinal Products for Human Use has concluded that etoricoxib’s benefits outweigh the risks in the treatment of rheumatoid arthritis. Furthermore, the Committee recommended extension of the indication to include ankylosing spondylitis at a dose of 90 mg once a day.
However, the Committee recommended an update to the existing contraindication in patients with inadequately controlled hypertension to state that patients whose blood pressure is persistently above 140/90 mmHg and inadequately controlled must not receive etoricoxib. Furthermore, high blood pressure should be controlled before starting treatment, and should be monitored for 2 weeks after the start of treatment and regularly thereafter.
Advice for healthcare professionals includes:
- prescribe etoricoxib in accordance with the above updated product information
- monitor patients closely for any signs and symptoms of cardiovascular side-effects (eg, fluid retention, high blood pressure, shortness of breath, or chest pain)
Article citation: Drug Safety Use July 2008; Vol 1, Issue 12: 10