Published: 29 April 2005

Safety Information

Prescribing Restrictions for all COX-2 Inhibitors

29 April 2005

After evaluation of the available data, and consideration of submissions from patients and health professionals, the Medicines Adverse Reactions Committee (MARC) has recommended that the COX-2 inhibitors celecoxib (Celebrex), etoricoxib (Arcoxia), lumiracoxib (Prexige), meloxicam (Mobic) and parecoxib (Dynastat) should not be withdrawn from the New Zealand market. However, the MARC considers that an increase in cardiovascular risk is a class effect for all COX-2 inhibitors. Therefore, the MARC have made the following recommendations to Medsafe in order to appropriately manage this increase in risk:

  • COX-2 inhibitors should be contraindicated:
    • In patients who have previously had a myocardial infarction or stroke
    • Peri-operatively in patients undergoing cardiac or vascular surgery
    • Peri-operatively in patients at high risk of cardiovascular disease undergoing major surgery.
  • Etoricoxib should be contraindicated in patients with poorly controlled hypertension.
  • COX-2 inhibitors should not be used unless alternative therapies have been used and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient.
  • COX-2 inhibitors should be commenced at and titrated to the lowest effective dose for pain control. Treatment should be limited to the shortest possible duration.
  • Patients should be reviewed after two weeks and the COX-2 inhibitor discontinued if there is a lack of therapeutic benefit. Patients requiring long-term therapy should be reviewed every three months to assess their ongoing need for treatment and the development of any new cardiovascular risk factors.
  • Prescribers should be aware that COX-2 inhibitors may exacerbate pre-existing hypertension, cardiac failure or oedema.
  • Aspirin should not be discontinued in patients requiring aspirin for cardiovascular prophylaxis. However, prescribers should be aware that there is no evidence that the use of aspirin mitigates the increased cardiovascular risk associated with COX-2 inhibitors. In addition, aspirin use has been shown to negate most of the gastrointestinal advantages associated with COX-2 inhibitors.
  • Prescribers must ensure that all patients at high risk of cardiovascular disease are informed that use of a COX-2 inhibitor might increase their risk of having a heart attack or stroke.
  • It is important that discussions regarding peri-operative use of COX-2 inhibitors are undertaken prior to surgery.

Medsafe is in the process of implementing the MARC's recommendations. Medsafe has also asked the COX-2 inhibitor product sponsors to continue with the voluntary moratorium on Direct-to-Consumer and professional advertising.

In light of the voluntary withdrawal of valdecoxib (Bextra) by Pfizer on 11 April 2005, Medsafe and the MARC are reviewing further safety information on this medicine. A decision regarding the most appropriate strategy to manage the risks associated with the use of Bextra is likely to be made after the next MARC meeting on 9 June 2005.

Further information is available on the Medsafe website

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