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NZ safety review of cox-2 agents

NZ safety review of cox-2 agents

11 February 2005

New Zealand's safety review of COX-2 agents to be released next week The Ministry's medicine regulatory arm, Medsafe, is expected to complete and release its review of the safety of COX-2 inhibitor pain-killers as early as next week.

Medsafe Principal Advisor Stewart Jessamine welcomes the Australian Therapeutic Goods Administration (TGA) review, which is the first of the major regulatory authorities to release their conclusions on the safety of this group of medicines. The TGA's media statement is available on the TGA web site.

Medsafe has worked closely with the Australian TGA, and their recommendations will be taken into consideration when a New Zealand decision is made.

The release of Medsafe's conclusions on the safety of COX-2 inhibitor pain-killers is likely to coincide with statements from the US and European regulatory agencies on the same subject.

The reviews by all four different regulatory agencies follow the worldwide recall of the COX-2 inhibitor, Vioxx in October last year. Dr Jessamine says in the interim, the Ministry advises that anyone taking a COX-2 inhibitor should follow the advice provided by the Ministry's expert committee, released in December last year, that COX-2 agents are not recommended:

· for routine use in patients with rheumatoid arthritis or osteoarthritis except where the patient is at "high risk" of developing a serious gastrointestinal adverse effect from other standard non-steroidal anti-inflammatory agents · for patients at high risk of heart attack or stroke · for patients already taking aspirin · for routine relief of post-operative pain.

Patients already taking COX-2 agents on a regular basis should discuss the continuing use of these medicines with their GP or specialist. Prescribers should discuss with their patients the available alternatives to the COX-2 agents, and review the risks and benefits of these alternatives compared with the emerging clinical concerns about the COX-2 agents, before deciding on the best course of treatment for that individual. If the patient and prescriber decide that continued use of a COX-2 agent is appropriate, use of the lowest effective dose is prudent.

A number of alternative anti-inflammatory agents for the treatment of osteoarthritis and rheumatoid arthritis are available in New Zealand. Unlike the COX-2 agents, many of these agents are funded by PHARMAC. Dr Jessamine says New Zealand makes its own decisions on medicine regulation separately from Australia. The prescribing, funding and marketing situation of the agents is slightly different in each country.

For example, in Australia, Mobic and Celebrex are funded, and Prexige, Arcoxia and Bextra are not currently available. In New Zealand all of the agents other than Prexige are actively marketed but none are funded.

For more information contact: Peter Abernethy Communications Manager ph: 04-496-2008 or 021-366-111 COX-2 agents available in NZ include: Ingredient Brand name celecoxib Celebrex valdecoxib Bextra meloxicam Mobic etoricoxib Arcoxia parecoxib Dynastat

Alternatives to COX 2 inhibitors - standard anti-inflammatory agents: Ingredient Brand names diclofenac Apo-Diclofenac Apo-Diclo SR Voltaren ibuprofen I-Profen Brufen Brufen Retard sulindac Clinoril Daclin tiaprofenic acid Surgam Surgam SA ketoprofen Orudis Oruvail naproxen Naxen Naprosyn SR Synflex tenoxicam Tilcotil piroxicam Piram D


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