Committee to decide fate of pain medicine in three weeks

A health expert advisory committee will meet in three weeks to decide the fate of cox-2 inhibitor pain relief medicines after warnings about their safety.

The Ministry of Health issued the warnings on Tuesday following a review of the medicines by Government medicine regulating agency Medsafe.

The review and subsequent warnings have attracted criticism from the manufacturer, Pfizer.

Medsafe said the initial conclusions of the review were that risks of heart attacks and strokes outweighed the benefits of the medicines for the general population.

Last October, international research lead to the voluntary recall of one cox-2 inhibitor, Vioxx, for the same reasons.

At least 60,000 people are estimated in the past year to have taken cox-2s, which include Celebrex, Arcoxia, Mobic, Dynastat and Bextra, which is popular for treating arthritis.

Pfizer said yesterday that Medsafe had informed it by letter that its preliminary intentions were to revoke marketing consent for Celebrex, Dynastat and Bextra.

The Health Ministry has indicated that evidence available on the medicines to date suggests they are likely to be pulled.

Pfizer general manager Mark Crotty said it was difficult to follow the thinking behind Medsafe's recommendation, and it appeared to be based on data from one incomplete study investigating Celebrex in cancer prevention.

"This study's preliminary results showed an increase in cardiovascular events - but at doses of 400 to 800mg a day, which is well in excess of the dosage [200mg or less] that approximately 90 per cent of New Zealanders are on," Mr Crotty said.

Rotorua rheumatologist Dr John Petrie said he was "astounded and deeply concerned" at the proposed withdrawal of the cox-2s.

Medsafe said it was seeking further information before making a final decision on the safety of the products.

The agency has invited pharmaceutical research, development and marketing company Merck Sharp & Dohme NZ to make further submissions on the issue, including its own research on the medicines.

Merck Sharp said the need for effective pain relief was important and it endorsed Arcoxia as a suitable therapeutic option for appropriate patients in New Zealand.

The company said all drugs carried risks and benefits.

- NZPA

The story so far

* A leading pain relief medicine, Vioxx, was recalled last October after research pointed to a higher rate of heart attacks and strokes among users.
* On Tuesday the Ministry of Health warned users of five similar medicines to see a doctor about stopping.
* Drug manufacturer Pfizer says it has been told that three of these medicines - Celebrex, Dynastat and Bextra - are likely to be withdrawn in New Zealand.