New Zealand. Following the recommendations made by New Zealand's Medicines Adverse Reactions Committee (MARC), the country's Ministry of Health has decided that COX-2 inhibitors will be allowed to stay on the market, but with "considerably stronger warnings"(1). New Zealand's Medicines and Medical Devices Safety Authority (Medsafe) has sent a fax to doctors and pharmacists communicating this decision, along with the following recommendations (2):
• COX-2 inhibitors should be contraindicated in patients with previous myocardial infarction (MI) or stroke and perioperatively for cardiac or vascular surgery, and perioperatively for major surgery in patients at high cardiovascular (CV) risk.
• Etoricoxib should be contraindicated in patients with poorly controlled hypertension.
• COX-2 inhibitors should not be used if alternatives exist, and, if used, the lowest effective dose should be used for the shortest possible duration.
• Patients should be reviewed after 2 weeks, with treatment discontinued in the absence of benefit, then reviewed every 3 months.
• Prescribers need to be aware that COX-2 inhibitors may exacerbate hypertension, cardiac failure or oedema.
• Prophylactic aspirin should not be discontinued.
• All patients at high CV risk should be informed of the risks with COX-2 inhibitors.
• Discussions regarding perioperative use of COX-2 inhibitors should be undertaken prior to surgery.
Medsafe is in the process of implementing MARC's recommendations and has asked that pharmaceutical companies continue with the voluntary moratorium on direct-to-consumer and professional advertising of COX-2 inhibitors.
1. Media Release. Medsafe, 29 April 2005 (http://www.medsafe.govt.nz).
2. Alert/letter to doctors and pharmacists. Medsafe, 29 April 2005 (http://www.medsafe.govt.nz).