Notice type: 3rd Party Publications

Date: 31/12/2006


Product name or type:

MIMS Publication - December 2006

Problem Or Issue:

Non-steroidal anti-inflammatory drugs (NSAIDs) are a class of medicinal products authorised for the treatment of arthritis and other inflammatory/painful conditions. This class of medicines includes both selective COX 2 inhibitors and non-selective NSAIDs. Following withdrawal of rofecoxib (Vioxx) from all worldwide markets in 2004, the safety profiles of NSAIDs have been re-assessed and closely monitored at national and European level. 

The most recently completed European-wide review, based on newly available data and analyses of cardiovascular safety from clinical and epidemiological studies has suggested a potentially increased arterial thrombotic risk (myocardial infarction or stroke) with some of the non-selective NSAIDs, especially if used at high doses and in long-term treatment. There are insufficient data to assess the thrombotic risk for other non-selective NSAIDs, therefore an increased risk cannot be excluded. 

The benefit/risk profile of piroxicam is currently being reassessed as part of a formal EU review procedure and as such a conclusion on its overall safety has not yet been reached. Information on the outcome of this review will be provided, when available. 

Although the overall benefit/risk profile of non-selective NSAIDs remains favourable when individual products are used in accordance with the recommendations and warnings specified in the relevant product information and taking account of individual patient risk factors, the IMB wishes to highlight the following information regarding the potential risk of cardiovascular, cerebrovascular and gastrointestinal effects: 


Prescribers should continue to choose NSAIDs on the basis of the overall safety profile of the product, described in the product information and taking account of the patient’s age, concomitant medications and individual risk factors.

The lowest dose for the shortest possible time necessary to relieve symptoms should be prescribed. 
Prescribers should not switch between NSAIDs without careful consideration of the overall safety profile of the products and the patient’s individual risk factors, as well as the patient’s preferences. 

For patients on chronic treatment, the need for therapy should be re-evaluated periodically, especially in patients with intermittent symptoms.

Gastrointestinal aspects: 

NSAIDs are contra-indicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy, active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). 

NSAIDs should be used with caution in patients at risk of gastrointestinal bleeding e.g. elderly patients and patients receiving concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, warfarin and aspirin. 

Concomitant aspirin treatment, which signals an increased risk for GI bleeding or CV complications, requires particular consideration and any need for gastro-protective treatment should be considered as part of individual risk assessment. 

Cardiovascular & cerebrovascular aspects: 

NSAIDs are contraindicated in patients with severe heart failure. 

NSAIDs should be used with caution in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Caution should also be exercised before initiation of treatment in patients with risk factors for the development of cardiovascular events (e.g. hyperlipidaemia, diabetes mellitus, smoking). 

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease and/ or cerebrovascular disease should only be treated with NSAIDs after careful consideration.

Background Information Or Related Documents:

« Back