The Pharmaceutical Journal
Vol 275 No 7372 p503
22 October 2005

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News summary

No new safety concerns for non-selective NSAIDs

There are no new safety concerns related to cardiovascular and gastrointestinal safety and serious skin reactions with non-selective non-steroidal anti-inflammatory drugs (NSAIDs), the European Medicines Agency (EMEA) has concluded (PDF 40K). However, the agency has identified key elements (PDF 50K) that it says should be included in all product information for non-selective NSAIDs.

“This is not based on new information, but reflects a common position on safety issues which are already well known among doctors and pharmacists in the EU,” the EMEA states.

The recommendations relate to contraindications, warnings and precautions for use, interactions with other medicines and undesirable effects. Details are available on the EMEA website (PDF 40K and PDF 50K).

The non-selective NSAIDs included in the review were diclofenac, etodolac, ibuprofen, indometacin, ketoprofen, meloxicam, nabumetone, naproxen, nimesulide and piroxicam.

A previous review had identified an increase in the risk of thrombotic events with selective cyclo-oxygenase inhibitors.