Pfizer New Zealand Waiting For Medsafe Advice

8 April 2005

Pfizer New Zealand Waiting For Medsafe Advice

“Medsafe is currently conducting a review of the safety of the class of Cox-2 inhibitors, including Bextra, the results of which are expected next week,” Pfizer NZ General Manger Mark Crotty said today.

The FDA in the United States yesterday informed Pfizer Inc that, in the agency’s view, Bextra’s cardiovascular risk could not be differentiated from other NSAIDS. However, the agency has concluded that the additional increased risk of rare but serious skin reactions 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 has agreed to suspend sales of the medicine pending further discussion with the FDA.

“Pfizer New Zealand Ltd has today been advised that the New Zealand regulatory agency Medsafe will be writing to Pfizer soon advising what action is required of Pfizer over Bextra. Bextra is available in New Zealand for the treatment of the signs and symptoms of Osteoarthritis and Rheumatoid Arthritis, and is taken by approximately 1500 patients.”

“Pfizer New Zealand has set up an information line for patients to contact the company for further information on (0800) 734 937, and advises patients taking Bextra to contact their Doctor.”

"Cox-2 inhibitors are important treatment options for all patients suffering the pain associated with arthritis, in particular for those that are unable to take conventional NSAIDs," Mr Crotty said.

“It is important to note that the FDA has also announced a decision requiring black box warning labels of potential cardiovascular risk for all Cox-2 pain relievers and all NSAIDS, including older non-specific drugs such as ibuprofen and naproxen,” Mark Crotty said.

ENDS

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