Piroxicam: new restrictions, including specialist initiation
- Medicines and Healthcare products Regulatory Agency
- 1 October 2007
- Therapeutic area:
- Pain management and palliation and Rheumatology
Systemic piroxicam should be initiated only by specialists as a second-line treatment for arthritis, with patients who currently take piroxicam reassessed at a routine appointment.
Article date: October 2007
Piroxicam is a non-steroidal anti-inflammatory drug (NSAID). Prescribing advice for systemic formulations of piroxicam is being amended in view of its safety profile (particularly the risk of serious gastrointestinal and skin reactions) compared with other NSAIDs.
New restrictions and general prescribing advice
- Licensed indications for adults are restricted to osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Systemic piroxicam is no longer indicated for any acute indications
- Existing indications for paediatric use are unchanged
- Only specialists (ie, consultants in rheumatology, rehabilitation medicine, medical orthopaedics, and general practitioners with a special interest [GPSIs] in rheumatology) should start new patients on piroxicam only as a second-line NSAID
- Maximum daily dose is 20 mg; review the need for continued treatment after 14 days, and frequently thereafter
- Consider the possible need for combination therapy with gastroprotective agents (eg, misoprostol or proton pump inhibitors), especially in the elderly; avoid use of piroxicam in patients older than 80 years
Revised contraindications include:
- history of, or active, gastrointestinal ulceration, bleeding, or perforation
- history of, or active, gastrointestinal disorders that predispose to bleeding abnormalities such as ulcerative colitis, Crohn’s disease, gastrointestinal cancers, and diverticulitis
- concomitant use with other NSAIDs, including COX-2 selective NSAIDs, aspirin at analgesic doses, and anticoagulants such as warfarin
- history of previous serious allergic drug reaction of any type, especially cutaneous reactions such as erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis
- previous hypersensitivity to piroxicam; skin reaction (irrespective of severity) associated with piroxicam, other NSAIDs, or other medicines
Revised warnings also highlight the need for caution when piroxicam is used with other drugs that may increase gastrointestinal risk (eg, selective serotonin reuptake inhibitors class of antidepressants and low-dose aspirin). Patients should stop taking piroxicam and seek medical advice at the first occurrence of gastrointestinal symptoms.
Assessment of patients who currently take piroxicam
Any patient who currently takes systemic piroxicam should be reviewed at a routine appointment. Patients who are receiving intermittent piroxicam treatment (eg, for flares of inflammatory arthritis) should be considered as a ‘new’ patient at the time of their next prescription, and either switched to an alternative treatment or referred to a specialist if piroxicam is still considered necessary. Patients who are receiving continuous long-term piroxicam treatment should be reassessed carefully in light of the increased risks of this treatment. If after full consideration of the risks and benefits there seems to be no alternative to piroxicam, specialist referral may be considered.
The above recommendations apply only to systemic formulations of piroxicam: there are no new restrictions on topical use.
Evidence of increased risk for piroxicam versus other NSAIDs
Available epidemiological evidence suggests that systemic piroxicam poses a significantly greater risk of serious gastrointestinal toxicity than other NSAIDs, including gastrointestinal haemorrhage, ulceration, and perforation.1 2 3
Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with NSAID use. Evidence from observational studies suggests that piroxicam may be associated with a higher risk of these reactions than other non-oxicam NSAIDs. Patients seem to be at highest risk of these reactions early in the course of therapy: most cases occur within the first month.
There is no apparent efficacy advantage for systemic formulations of piroxicam versus other NSAIDs.
For further information see New restrictions on the use of the anti-inflammatory drug piroxicam
Article citation: Drug Safety Update October 2007; Vol 1, Issue 3: 2.
Published: 1 October 2007