European Medicines Agency Recommends Restricted Use For Piroxicam

The European Medicines Agency (EMEA) has recommended restrictions on the
use of piroxicam-containing medicinal products because of the risk of
gastrointestinal side effects and serious skin reactions. The Agency's
Committee for Medicinal Products for Human Use (CHMP) concluded that
piroxicam should no longer be used for treatment of short-term painful
and inflammatory conditions. Piroxicam can still be prescribed for the
symptomatic relief of osteoarthritis, rheumatoid arthritis and
ankylosing spondylitis. However it should not be the first choice of
non-steroidal anti-inflammatory drug (NSAID) treatment in these
conditions.



Prescription of piroxicam should always be initiated by a physician
experienced in the treatment of patients with inflammatory or
degenerative rheumatic diseases and treatment should be used in the
lowest dose (no more than 20 mg per day) and for the shortest duration
possible. In any case, the treatment should be reviewed after the first
14 days of starting.



In addition, the CHMP recommended new contraindications and strengthened
warnings for piroxicam, further details of which are provided in a
separate question-and-answer document.



Topical medicines containing piroxicam are not concerned by these
restrictions.



Further to the request of the European Commission, the CHMP initiated a
full assessment of the benefits and risks of piroxicam in September
2006, because a review of non-selective NSAIDs showed that piroxicam
could be associated with a higher risk of gastrointestinal side effects
and serious skin reactions than other non-selective NSAIDs.



The CHMP recommendations will now be forwarded to the European
Commission for adoption of a legally binding decision, applicable in all
EU Member States.


1. The safety review was conducted in accordance with Article 31 of
the Community code on human medicinal products (Directive 2001/83/EC as
amended).


2. More information about the recommendations for piroxicam is
available in a separate question- and-answer document here
here.


3. A press release announcing the start of the procedure for
piroxicam can be found
here.


4. More information about the review of NSAIDs can be found
here.


5. This press release, together with other information about the
work of the EMEA, may be found on the EMEA website:


European Medicines Agency (EMEA)