NEWS - New Zealand says risks of COX-2 inhibitors outweigh benefits

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New Zealand says risks of COX-2 inhibitors outweigh benefits

Mar 8, 2005 Zosia Chustecka

Auckland, New Zealand - New Zealand has issued the strongest warning so far

on COX-2 inhibitors, ruling that the increased risk of cardiovascular events

(myocardial infarction and stroke) outweighs the benefits of these drugs in

the general population [1].

The New Zealand Ministry of Health is advising people who are at high risk

of cardiovascular events to see their doctor to discuss stopping COX-2

inhibitors immediately. This includes individuals with a previous history of

myocardial infarction or stroke, with a strong family history of heart

disease, with a history of diabetes, smoking, hypertension, or who are

taking lipid-lowering drugs.

All other patients taking a COX-2 inhibitor should discuss stopping the drug

and consider alternative treatment options at their next scheduled

appointment, the ministry says.

The ruling applies to 5 products currently available in New Zealand:

celecoxib (Celebrex, Pfizer), etoricoxib (Arcoxia, Merck & Co), valdecoxib

(Bextra, Pfizer), the injectable product parecoxib (Dynastat, Pfizer), and

meloxicam (Mobic, Boehringer Ingelheim). It is estimated that at least 60

000 people in New Zealand have taken 1 of these drugs in the past year.

The advice issued by the Ministry of Health is preliminary and will be

reviewed at a meeting later this month. It was issued after a review of

COX-2 inhibitors undertaken by Medsafe, the medicines regulatory body, after

the voluntary withdrawal of rofecoxib (Vioxx, Merck & Co) late last year.

Medsafe considered data on the safety and efficacy in both published

literature and that submitted by the manufacturers. " 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, " says Dr

Jessamine, spokesperson for the Ministry of Health. " While there is

uncertainty about the degree of risk posed by each medicine, on the basis of

evidence available to date, Medsafe's opinion is that the possible increase

in heart attack and stroke outweighs the benefits of COX-2 inhibitors for

the general population. "

This is a " more cautious approach " than has been taken by other regulatory

bodies, the ministry comments in a press statement. Although Australia, the

European EMEA, and the US FDA reached similar conclusions that the increased

cardiovascular risk is a class effect and is present in all COX-2-inhibitor

medicines, the preliminary advice issued in New Zealand differs from that

issued by these other groups. It was based on Medsafe's opinion that

prescribing, funding, and the consumer environment in New Zealand are

different from these other entities. For example, none of the 5 products

that are actively marketed are government funded, and so Medsafe has only

limited information on how these drugs are being prescribed. In contrast, in

Australia, 2 of the 5 products are government-funded.

Patients stopping COX-2 inhibitors are advised to consider alternative

therapies. The Ministry says alternative anti-inflammatory drugs that are

available in New Zealand include the following: diclofenac, ibuprofen,

sulindac, tiaprofenic acid, ketoprofen, naproxen, tenoxicam, and piroxicam.

Source

New Zealand Ministry of Health. Ministry of Health issues

strong warning on COX-2 inhibitors, February 22, 2005. Available here.

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