Europe. Based on the assessment of available evidence on thrombotic risk associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs), and pending the ongoing review of other safety issues, the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) does not currently recommend any changes to the advice to prescribers and patients. The CHMP highlights that the overall safety profiles of non-selective NSAIDs and the risk factors for each patient should be the basis for prescribing decisions, and that non-selective NSAIDs should be used at the lowest effective dose for the shortest period necessary for symptom control. Non-selective NSAIDs reviewed by the CHMP include diclofenac, etodolac, ibuprofen, indomethacin, ketoprofen, meloxicam, nabumetone, naproxen and nimesulide. In its press release, the Agency notes that the revised prescribing advice adopted in June 2005 for selective COX-2 inhibitors (eg celecoxib, etoricoxib, lumiracoxib and parecoxib) remains unchanged. (The June 2005 advice was based on a review that had identified an increase in the risk of thrombotic adverse cardiovascular reactions such as heart attack or stroke with selective COX-2 inhibitors).

References:

Press Release. European Medicines Agency, 29 July 2005 (http://www.emea.eu.int).