The European Medicines Agency (EMEA) has recommended that the warnings and contraindications for etoricoxib are strengthened following a review conducted as part of a licence extension application.
The review assessed the risks and benefits of etoricoxib at a dose of 90mg per day for rheumatoid arthritis and ankylosing spondylitis. It was concluded that the benefits outweigh the risks but that several measures are added to prescribing information to reduce the risks of treatment.
These recommendations are detailed in a question and answer document. It is recommend that:
- Etoricoxib must not be used in patients whose blood pressure is persistently above 140/90 mmHg
- Blood pressure must be controlled before starting treatment
- Blood pressure should be monitored for two weeks after the start of treatment and regularly thereafter
Action: Clinicians should be aware of these new recommendations. As with all non-steroidal anti-inflammatory drugs (NSAIDs), cardiovascular, gastrointestinal and renal risks should be assessed before starting treatment.
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