Notice type: 3rd Party Publications

Date: 30/09/2005


Product name or type:
Cardiovascular Review of Non-Selective Non-Steroidals - MIMS

MIMS Publication September 2005

Prescription Required:

Problem Or Issue:
Following concerns that the increased risk of myocardial infarction and stroke previously identified in association with selective COX-2 inhibitors may also apply to nonselective NSAIDs, the Health Products Regulatory Authority (IMB) in conjunction with its EU counterparts participated in a review of available safety data for these products. This review concluded that there is insufficient evidence to warrant any regulatory action regarding thrombotic risk of non-selective NSAIDs at present. 

However, healthcare professionals are reminded of the following information and recommendations regarding their use:
• Non-selective NSAIDs are widely-used, effective medicines for the treatment of arthritis and other painful conditions 
• Prescribing should be based on overall safety profiles of NSAIDs (particularly gastro-intestinal concerns), as described in the product information and taking account of risk factors for individual patients 
• Switching treatment between non-selective NSAIDs is not justified, on the basis of the available evidence 
• All patients should take the lowest effective dose of non-selective NSAIDs (or COX-2 inhibitors) for the shortest time necessary to control symptoms.

Further data from clinical trials, which will provide additional information on the risk of thrombotic effects of NSAIDs are expected within the next year. These data, together with safety information on skin and gastrointestinal effects, will continue to be monitored closely by the IMB and other EU regulatory agencies. The IMB will keep healthcare professionals informed of the progress and outcome of evaluation of the additional data as and when it becomes available. 

In the meantime, advice regarding selective COX-2 inhibitors remains unchanged, as follows:
 Use of COX-2 inhibitors is contraindicated in patients with ischaemic heart disease or stroke 

• Etoricoxib is also contraindicated in patients with hypertension (high blood pressure), whose blood pressure is not under control 

• Prescribers are advised to exercise caution when prescribing COX-2 inhibitors for patients with risk factors for heart disease, such as hypertension, hyperlipidaemia, diabetes and smoking, as well as for patients with peripheral arterial disease 

Given the association between cardiovascular risk and exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest possible duration of treatment. 

Any suspected ADRs should be notified to the IMB in the usual way. A version of the ADR report form is available to download from the HPRA’s website ( 

Downloaded forms may be completed and sent by freepost to the HPRA. Envelopes should be marked “Freepost”, Pharmacovigilance Unit, Health Products Regulatory Authority, The Earlsfort Centre, Earlsfort Terrace, Dublin 2.
Alternatively completed forms may be submitted by fax (01- 6762517). 
Post-paid report cards are also available from the Pharmacovigilance Unit at the HPRA (01- 6764971).

Background Information Or Related Documents:

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