Pfizer Disappointed Medsafe May Deny Arthritis Med

Pfizer New Zealand Says Doubt Over Future Health Of 60,000 Arthritis Patients

Pfizer New Zealand Ltd is disappointed with a preliminary recommendation by health officials that could deny 60,000 New Zealanders access to important arthritis medications.

Pfizer New Zealand received a letter from the Government agency, Medsafe, on Friday, announcing its preliminary intention to revoke marketing consent for the company’s COX-2 inhibitor arthritis medications, Celebrex, Dynastat and Bextra.

“It’s difficult to follow the thinking behind the preliminary recommendation which appears to be based on data from one uncompleted study investigating Celebrex in cancer prevention (the APC study),” Pfizer General Manager Mark Crotty said.

”This study's preliminary results showed an increase in cardiovascular events - but at doses of 400-800mg a day, which is well in excess of the dosage (200mg or less) that approximately 90 percent of New Zealanders are on.”

Rheumatologist from Queen Elizabeth Hospital, Rotorua, Dr John Petrie said he is astounded and deeply concerned with the proposed withdrawal of the COX-2s.

"These are important treatment options for all patients suffering the pain associated with Arthritis, in particular for those that are unable to take conventional NSAIDs due to gastro- intestinal side effects," he said.

"I believe that products like Celebrex are as safe as all other anti-inflammatory products available in New Zealand.

"Patients will be forced to move back to NSAIDs, a group of pain killers whose cardiovascular and gastro-intestinal safety has not been demonstrated to be superior to COX-2s."

Pfizer New Zealand said Medsafe's apparent intention to revoke the consent for Bextra, which is available in New Zealand for the treatment of the signs and symptoms of Osteoarthritis and Rheumatoid Arthritis, is inappropriate and not justified by the data.

Approximately 1500 patients take Bextra in New Zealand.

Medsafe is also seeking to revoke consent for Dynastat, a single-dose post-operative pain reliever only used in hospitals which may decrease the need for opioids

Pfizer NZ is providing further information to Medsafe to assist it in its evaluation of Pfizer’s arthritis medications.

Pfizer advises patients with any concerns to contact their doctor.

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