The Committee for Medicinal Products for Human Use (CHMP), and committee within the EMEA, concluded that:
- Non-selective NSAIDs are important treatments for arthritis and other painful conditions.
- It cannot be excluded that non-selective NSAIDs may be associated with a small increase in the absolute risk for thrombotic events, especially when used at high doses for long-term treatment.
- The overall benefit-risk balance for non-selective NSAIDs remains favourable when used in accordance with the product information, namely on the basis of the overall safety profile of the respective non-selective NSAID, and taking into account the patient's individual risk factors (for example gastrointestinal, cardiovascular and renal).
The risk-benefit of piroxicam is being assessed separately.
The CHMP confirmed its previous advice that patients should receive the lowest dose of non-selective NSAID, for the shortest duration possible.