CHMP ADVICE—PIROXICAM (JUNE 2007)
▶With systemic use
The CHMP has recommended restrictions on the use of
piroxicam because of the increased risk of gastro-
intestinal side effects and serious skin reactions. The
CHMP has advised that:
. piroxicam should be initiated only by physicians
experienced in treating inflammatory or degenerative
rheumatic diseases
. piroxicam should not be used as first-line treatment
. in adults, use of piroxicam should be limited to the
symptomatic relief of osteoarthritis, rheumatoid
arthritis, and ankylosing spondylitis
. piroxicam dose should not exceed 20 mg daily
. piroxicam should no longer be used for the treatment
of acute painful and inflammatory conditions
. treatment should be reviewed 2 weeks after initiating
piroxicam, and periodically thereafter
. concomitant administration of a gastro-protective
agent should be considered.
Topical preparations containing piroxicam are not
affected by these restrictions.
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→Appendix 1: NSAIDs
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GENERAL SIDE-EFFECTS
▶Common or very common Gastrointestinal discomfort.
gastrointestinal disorders. nausea. skin reactions
▶Rare or very rare Severe cutaneous adverse reactions
(SCARs)
▶Frequency not known Bronchospasm. dyspnoea.
photosensitivity reaction
SPECIFIC SIDE-EFFECTS
▶Common or very common
▶With oral use Anaemia. appetite decreased. constipation.
diarrhoea. dizziness. drowsiness. eosinophilia. headache
. hyperglycaemia. leucopenia. oedema. rash (discontinue)
. thrombocytopenia. tinnitus. vertigo. vomiting. weight
changes
▶Uncommon
▶With oral use Hypoglycaemia. palpitations. stomatitis.
vision blurred
▶Rare or very rare
▶With oral use Nephritis tubulointerstitial. nephrotic
syndrome. renal failure. renal papillary necrosis
▶Frequency not known
▶With oral use Alopecia. angioedema. aplastic anaemia.
confusion. depression. embolism and thrombosis. eye
irritation. eye swelling. fertility decreased female. fluid
retention. haemolytic anaemia. haemorrhage.
hallucination. hearing impairment. heart failure. hepatic
disorders. hypersensitivity. hypertension. malaise. mood
altered. nervousness. onycholysis. pancreatitis.
paraesthesia. sleep disorders. vasculitis
SIDE-EFFECTS, FURTHER INFORMATION For information
about cardiovascular and gastrointestinal side-effects, and
a possible exacerbation of symptoms in asthma, see Non-
steroidal anti-inflammatory drugs. p. 1193
Topical application of large amounts can result in
systemic effects.
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▶With systemic use Caution—long-term use of some NSAIDs
is associated with reduced female fertility, which is
reversible on stopping treatment.
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▶With systemic use Avoid unless the potential benefit
outweighs the risk. Avoid during the third trimester (risk of
closure of fetal ductus arteriosus in utero and possibly
persistent pulmonary hypertension of the newborn); onset
of labour may be delayed and duration may be increased.
▶With topical use Patient packs for topical preparations carry
a warning to avoid during pregnancy.
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▶With systemic use Use with caution during breast-feeding.
Amount too small to be harmful.
▶With topical use Patient packs for topical preparations carry
a warning to avoid during breast-feeding.
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▶With oral use Manufacturer advises caution.
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▶With systemic use Avoid if possible or use with caution.
▶With topical use Deterioration in renal function has also
been reported after topical use.
Dose adjustments ▶With systemic use The lowest effective
dose should be used for the shortest possible duration.
Monitoring ▶With systemic use In renal impairment
monitor renal function; sodium and water retention may
occur and renal function may deteriorate, possibly leading
to renal failure.
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