MEDIA STATEMENT

28th September 2006

Further comment
From the International Ibuprofen Foundation
Following EMEA press release on the review of NSAIDs


It should be emphasised that the review is exclusively confined to prescription use of NSAIDs including Ibuprofen ie high doses and long duration and is not in any way associated with over-the-counter (OTC) low doses for minor ailments by the general public.

The patients in this study were taking high doses of at least 800mg, 3 times a day; this is twice the recommended maximum dose for over-the-counter use. Experts have stressed the health fears only apply to high doses of NSAIDs prescribed by GPs and not the Ibuprofen and other pills bought over-the-counter.

Ibuprofen has been available to the public directly for many years OTC and is known to be effective and well tolerated. Prescription use is generally for longer periods, in higher doses and is known to have a different safety profile from self-medication usage at low doses. Self medication ibuprofen is a very safe and effective medicine, and research shows that Ibuprofen at non-prescription doses is not associated with increased risk of heart attack. 1 2 3

When the European Medicines Agency held a similar review in October 2005 their conclusions were, “There are no new concerns about the safety of NSAIDs such as ibuprofen”. This decision was reached having reviewed a wide range of evidence.

Ends


Addendum
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has stated ‘Ibuprofen has an excellent safety record’

1 Patel NT, Goldberg KC Arch Intern Med 2004; 164:852-856
2 Kurth T, et al. Curculation 2003;108 :1191-1195
3 Hudson M et al, Anti-inflammatory drugs are associated with a decreased risk of recurrent acute myocardial infarction in patients on aspirin. American College of Rheumatology Annual Scientific Meeting 2003




Further comment from the IIF:


It is important that the media in reporting scientific data concerning ibuprofen consistently distinguish between prescription use of ibuprofen dose forms designed for use under strict medical supervision and less potent dose forms available to the general public over-the-counter.

There has been consistent confusion in media interpretation of data which has lead to inappropriate comment and concern for the public who may be less able than journalists to distinguish between OTC use and prescription use.

It is important therefore that the public should be provided with unsensational and objective media reports.

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