Notice type: 3rd Party Publications

Date: 31/12/2005


Product name or type:
NSAIDs- MIMS Advisory

MIMS Publication December 2005

Problem Or Issue:
Further to an update on the outcome of the cardiovascular review of the safety of non-selective NSAIDs published in the September issue of MIMS, reviews of gastrointestinal and skin safety undertaken at EU level have recently been completed. 

These reviews concluded that there are no new public health concerns regarding the use of these products that warrant immediate regulatory action. However, it was agreed that contraindications and warnings for their use should be harmonised across the EU, in line with the following: 


• History of gastrointestinal bleeding or perforation, related to previous NSAID therapy. 
• Active, or history of recurrent peptic ulcer/haemorrhage. 

Special Warnings 
• Use with concomitant NSAIDs, including cyclooxygenase-2 selective inhibitors should be avoided. 
• Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms. 
• Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal. 
• GI bleeding, ulceration or perforation, which may be fatal, has been reported in association with all NSAIDs. Such reactions may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events. 
• NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated. 
• The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk. 
• Patients with a history of GI toxicity, particularly when elderly, should be advised to report any unusual abdominal symptoms (especially GI bleeding), particularly in the initial stages of treatment. 
• Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotoninreuptake inhibitors, or anti-platelet agents such as aspirin. 
• When GI bleeding or ulceration occurs in patients, treatment should be withdrawn. 

• Severe heart failure. 

Special Warnings 
• Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy. 


Special Warnings 
• Serious skin reactions, some of which have been fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported very rarely in association with the use of NSAIDS. Patients appear to be at highest risk for these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. NSAID treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Background Information Or Related Documents:
NSAIDs Document

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