Drugs Xagena
Healthcare professionals have previously been informed of the risk of hypertension-related adverse events associated with use of Etoricoxib ( Arcoxia ), and of the contraindication for use of Etoricoxib in patients with hypertension whose blood pressure is not adequately controlled. The European Medicines Agency ( EMEA )
has recently completed a review of the benefits and risks of 90 mg Etoricoxib in the treatment of rheumatoid arthritis and in ankylosing spondylitis. The review included analyses from an observational database ( General Practice Research Database ) study, which suggest that a substantial number of patients with systolic blood pressure greater than 150mmHg and/or diastolic BP greater than 90mmHg have been initiated on Etoricoxib despite earlier recommendations.
Prescribers are therefore asked to note the following updated and strengthened safety recommendations:
Etoricoxib should not be used in patients with hypertension whose blood pressure is persistently elevated above 140/90 mmHg and has not been adequately controlled.
In all patients starting treatment with Etoricoxib, blood pressure should be monitored within 2 weeks after initiation, and periodically thereafter.
These changes have to now be incorporated into the UK licences for Etoricoxib and we will be issuing a revised SmPC later this year.
Source: Medicines and Healthcare product Regulatory Agency MHRA, 2008
XagenaMedicine_2008
