New Zealand - The class of medicines known as COX-2 inhibitors will stay on the market, but with considerably stronger warnings for their use and the requirements for pharmaceutical companies to collect and report information on usage. Pharmaceutical companies will also have to provide additional safety information as it becomes available. The Ministry of Health is also seeking to extend, until further notice, the voluntary ban by pharmaceutical companies on promoting these products.
Recommendations made by the Medicines Adverse Reactions Committee (MARC), and accepted by the Ministry of Health, end months of uncertainty for patients. A review of the cardiovascular safety of the COX-2 inhibitors was begun in October 2004 after rofecoxib (Vioxx®), one of six COX-2 inhibitors marketed in New Zealand, was withdrawn after international findings that its use was associated with an increased risk of heart attacks and strokes. these medicines are the best treatment option and giving doctors and patients enough information will allow both to weigh up the risks and benefits. Both the Royal Australasian College of Surgeons and the Australian and New Zealand College of Anaesthetists have been advised that it is crucial for their members to carry out a full risk-benefit analysis for all patients, and that they fully inform patients of the risks and benefits before routinely using COX-2 inhibitors for relief of pain and inflammation associated with an operation.
Medsafe and the University of Otago Pharmacovigilance Centre will be monitoring these products. MARC has recommended prohibiting direct-to-consumer advertising of COX-2 inhibitors, and there has been a voluntary moratorium in place since December 2004.
COX-2 inhibitors available in New Zealand:
[Valdecoxib (Bextra®) was voluntarily withdrawn April 2005.]
Reference: Media Release. Stringent Conditions for COX-2 Inhibitors, 29 April 2005 on http://www.medsafe.gov.nz