11 April 2005
PFIZER NEW ZEALAND BEXTRA ADVISORY
Pfizer New Zealand will voluntarily suspend the marketing and distribution of Bextra and withdraw the product to
pharmacy level, following a request from the regulator Medsafe.
Pfizer New Zealand general Manager Mark Crotty said Medsafe requested the voluntary suspension following similar actions
in the US and EU, to allow further review of the overall benefit: risk of Bextra. Pfizer New Zealand is complying with
this request to ensure consistency with other markets.
“After discussions with Medsafe, we are advising patients to seek a non-urgent appointment with their doctor to discuss
stopping treatment of Bextra”
“This is not a recall to patient level.”
Last week the US FDA informed Pfizer Inc that, in the agency’s view, Bextra’s cardiovascular risk could not be
differentiated from other NSAIDs. The agency has concluded that the additional increased risk of rare but serious skin
reactions (SCAR) associated with Bextra, already described in its label, warrants its withdrawal.
Pfizer Inc respectfully disagrees with the FDA’s position regarding the overall risk/benefit of Bextra, however, in
deference to the agency’s views the company agreed to suspend sales of the medicine in the USA pending further
discussions with the FDA.
Bextra is available in New Zealand for the treatment of the signs and symptoms of osteoarthritis and rheumatoid
arthritis, and was taken by approximately 1500 patients prior to the initiation of the review of the COX-2 inhibitor
class in December 2004. There is currently precautionary advice in the prescribing information and consumer medicine
information regarding the risk of developing serious cutaneous adverse reactions when taking Bextra.
Pfizer New Zealand has set up an information line for patients to contact the company for further information on (0800)
734 937.
ENDS