MEDIA RELEASE

20th October 2005

No new safety concerns about NSAIDs after Europe-wide review


There are no new concerns about the safety of non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, the European Medicines Agency has concluded that after reviewing a wide range of evidence.

The review was carried out when it became known that some newer NSAIDs, known as COX-2 selective NSAIDs, are associated with an increased risk of heart attack, stroke and, for some drugs, serious skin reactions1. The Agency reviewed what was known about the safety of older NSAIDs that are not COX-selective2, and concluded that there are no such new concerns about their cardiovascular or gastrointestinal safety or their risk of serious skin reactions3. NSAIDs remain important treatments for arthritis and other painful conditions, the Agency notes.

The Agency confirmed current advice about taking NSAIDs, whether prescribed or over-the-counter, that the lowest effective dose should be taken for the shortest possible time required to control symptoms.

The Agency has instructed member states within the European Union to standardise the safety information provided in Summaries of Product Characteristics for all non-selective NSAIDs4. Again, this was not based on new information but reflected a common position on safety issues already known to health professionals.

- ENDS -

Notes for editors
1. More information about the risk of cardiovascular events and skin reactions associated with COX-2 selective NSAIDs is available at www.ibuprofen-foundation.com/news/documents/IbuandCOX2s.pdf.

2. The review included prescription formulations of ibuprofen, diclofenac, etodolac, indomethacin, ketoprofen, meloxicam, nabumetone, naproxen, nimesulide and piroxicam. The evidence considered included epidemiological studies, clinical trials and post-marketing surveillance data.

3. The review was carried out by the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, at the request of the European Commission. More detail are available from the Agency's website at www.emea.eu.int/htms/hotpress/h29896405.htm and www.emea.eu.int/pdfs/human/press/pr/30009505en.pdf.

4. Further details about standardising safety information for NSAIDs are available from the Agency's website at www.emea.eu.int/pdfs/human/press/pr/34345605en.pdf.

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