New Zealand bans, restricts Cox-2 drugs

MedSafe, the Ministry of Health in New Zealand says the increased risk of heart attack and stroke (cardiovascular events) outweighs the benefits of COX-2 inhibitor drugs for the general population. This is in total contrast to the recommendations of the Food & Drug Administration (FDA) panel in the United States which found that despite the higher risks from Cox-2 inhibitor drugs, these should be left on the market. That means that Vioxx which was recalled in September 2004 due to safety concerns is likely to show up on pharmacy shelves in the US, though with a black box warning, and Celebrex and Bextra will also likely to be available, again with black-box warnings.

MedSafe is advising New Zealand nationals, who are at high risk of cardiovascular events, to see their doctor to discuss stopping treatment with COX-2 inhibitors immediately. Others taking the medicines, but not at high risk should discuss cessation of the COX-2 inhibitor at their next scheduled doctor's appointment and consider alternative treatment options. (Related article: Celebrex and Bextra have same risks as Vioxx, argues Merck)

"We don't have enough information yet to quantify the risk associated with each of the five Cox-2 inhibitors currently available in New Zealand," Ministry spokesman Dr Stewart Jessamine said. "But our preliminary conclusions are that all COX-2 inhibitors may increase the risk of developing a heart attack or stroke to some degree in some patients." New Zealand has more choices for arthritis patients than in the US and the Cox-2 drugs available there are Celecoxib (Celebrex), Etoricoxib (Arcoxia), Meloxicam (Mobic), Parecoxib (Dynastat), and Valdecoxib (Bextra). (Related article: Making sense of FDA panel recommendations on Vioxx, Celebrex, and Bextra)

Dr Jessamine said those at high risk were patients with a previous history of heart attack or stroke; a strong family history of heart disease; a history of diabetes, smoking, hypertension, or who are on treatment for high cholesterol. "Unfortunately despite reviewing extensive amounts of data, there is still not enough information to quantify the risk associated with each of these medicines, or to determine which patients are at increased risk or whether aspects of treatment such as dose or duration of use affect the degree of risk," Dr Jessamine said. (Related article: European Union authorities restrict/ban prescription of Cox-2 drugs)

Medsafe is seeking further information from the pharmaceutical industry and the published literature before making a final decision on the safety of these products. The Medicines Adverse Reactions Committee will discuss Medsafe's preliminary conclusions and any further data published or submitted on the safety of the COX-2 inhibitors at its March 2005 meeting. Any FDA or European regulatory agency findings made in the interim will also be considered at this meeting.

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