The Pharmaceutical Journal
Vol 277 No 7424 p503
28 October 2006

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MHRA issues warning over high-dose NSAIDs

Non-selective non-steroidal anti-inflammatory drugs (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. This is the conclusion of a review of NSAID safety data released this week by the Committee for Medicinal Products for Human Use, a division of the European Medicines Agency (EMEA).

Based on the EMEA’s findings, the Medicines and Healthcare products Regulatory Agency’s Commission on Human Medicines has this week written to health care professionals offering the following advice:

· The lowest effective dose of NSAID or selective cyclo-oxygenase-2 (COX-2) inhibitor should be prescribed for the shortest time necessary for control of symptoms. The need for long-term treatment should be reviewed periodically.

· Prescribing should be based on the safety profiles of individual NSAIDs or selective COX-2 inhibitors and on individual patient risk profiles.

· Prescribers should not switch between NSAIDs without careful consideration of the overall safety profile of the products, a patient’s individual risk factors and patient preference.

· Concomitant aspirin (and possibly other antiplatelet drugs) greatly increases the gastrointestinal risks of NSAIDs and severely reduces any gastrointestinal safety advantages of selective COX-2 inhibitors. Aspirin should only be co-prescribed if absolutely necessary.

The letter also says: “A review of the safety of NSAIDs in 2005 concluded that there were inadequate data to update prescribing advice [PJ, 22 October 2005, p503]. However, sufficient evidence has now accrued to suggest that some NSAIDs may be associated with a small increased risk of thrombotic events when used at high doses and for long-term treatment, that diclofenac has a thrombotic risk profile similar to that of licensed doses of etoricoxib and that naproxen is associated with a lower risk than [selective COX-2 inhibitors].”

According to the MHRA, the pharmaceutical industry will be asked to update any summaries of product characteristics for NSAIDs, based on the CHM’s recommendations.