Revised: 26 June 2013

Safety Information

Medsafe advises review of all patients on COX-2 inhibitors

22 February 2005

Important information for doctors and pharmacists:

The preliminary findings of Medsafe's review of the cardiovascular safety of the COX-2 inhibitors (i.e. celecoxib, etoricoxib, lumiracoxib, meloxicam, parecoxib and valdecoxib) are that:
  • The increased risk of cardiovascular events outweighs the benefits of COX-2 inhibitors for the general population.
  • Prescribers should immediately review the use of COX-2 inhibitors in patients at high absolute risk of cardiovascular events; COX-2 inhibitors should be discontinued in these patients.
  • For all other patients, cessation of COX-2 inhibitor use should be discussed at the next scheduled doctor's appointment and alternative treatment options considered.

Medsafe's review concluded that there is a plausible biological mechanism to explain an increased risk of cardiovascular thromboembolic events associated with selective COX-2 inhibition. The level of risk may be partly dependent on dose and degree of COX-2 specificity. There is evidence of increased cardiovascular risk with long and short-term COX-2 inhibitor use in patients with or without cardiovascular risk factors.

However, there is currently insufficient evidence to quantify either the risks associated with the dose and duration of use for each COX-2 inhibitor, or the predisposing factors that may increase cardiovascular risk. Consequently, at this point in time, it is not possible to identify a group of patients in whom cardiovascular risk-free use of a COX-2 inhibitor can be assured.

Guidance on alternative analgesic options and management of patients at high risk of gastrointestinal harm has recently been issued by BPAC (NSAIDs - strategies for minimising harm) and is available on their website.

Medsafe will further update prescribers about the status of the COX-2 inhibitors following a meeting of the Medicines Adverse Reactions Committee on 15 March 2005. In the meantime, there is additional information on the Medsafe web site:


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