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PJ Online homeThe Pharmaceutical Journal
Vol 278 No 7458 p760
30 June 2007

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New restrictions on piroxicam prescribing

New restrictions on the use of piroxicam have been issued by the European Medicines Agency (EMEA) because of the risk of gastrointestinal side effects and serious skin reactions. The restrictions apply to the oral, injectable and suppository forms of the drug but not to topical preparations.

The new prescribing advice is based on the opinion of the EMEA’s Committee for Medicinal Products for Human Use (CHMP), that piroxicam should no longer be used for the short-term treatment of painful and inflammatory conditions. The drug can still be prescribed for long-term relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis but should not be first-line non-steroidal anti-inflammatory drug therapy.

The Medicines and Healthcare products Regulatory Agency advises that there is no need for urgent action but that patients being treated for long-term conditions with piroxicam should have their treatment reviewed at their next routine appointment. An alternative treatment should be considered if appropriate.

Patients who have previously received piroxicam for short-term use should receive an alternative medicine if similar treatment is needed in the future.

The MHRA also advises that, for all NSAIDS, the lowest effective dose should be used for the shortest period necessary to control symptoms.

Prescribers will receive a letter to inform them of these changes in the near future. Summaries of product characteristics will be updated when the CHMP opinion is ratified by the European Commission.

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