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 agencyâ€™s view, Bextraâ€™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 FDAâ€™s position regarding the overall risk/benefit of Bextra, however, in deference to the agencyâ€™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.