Restricted use of piroxicam for pain relief

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommends restrictions in the use of medicinal products containing piroxicam, which is used to relieve pain. The restrictions do not apply to Piroxicam, in the form of e.g. cream or gel, used to treat local conditions.

The recommendation is based on a review of NSAIDs (non-steroidal anti-inflammatory drug) including piroxicam, which CHMP has performed on efficacy and safety in particular of the use of NSAIDs in 2005 and 2006, read more in the factbox to the right. Based on this review, the need emerged to look closer at the benefits and risks of piroxicam – in particular the risk of gastrointestinal side effects and serious skin reactions. In 2006, 13,900 patients were issued a prescription for a piroxicam-containing medicinal product in Denmark .

CHMP’s recommendations
CHMP recommends that piroxicam is used only to treat pains and inflammatory joints in patients with rheumatoid arthritis, degenerative arthritis (osteoarthritis) and Bechterew’s disease (‘arthritis of the spine’ Ankylosing Spondylitis). Furthermore, piroxicam should not be the first choice, which means that patients suffering from either of the above three diseases must first try other medicinal products before switching to piroxicam.

The CHMP moreover recommends that piroxicam always be prescribed by a physician experienced in the treatment of patients with the above-mentioned diseases and that treatment only be used in the lowest dose (no more than 20mg a day) and for the shortest duration possible. The affect and possible side effects should be assessed after the first 14 days of treatment with piroxicam, and the physician must then decide whether to continue the treatment.

The summary of product characteristics and patient information leaflets will be changed in compliance with the above.

For further information, please contact Chief Medical Officer Steffen Thirstrup, telephone +45 4488 9187.

The Danish Medicines Agency, 26 June 2007