Europe’s regulatory advisory body, the CHMP, yesterday said it would not further strengthen the warning labels for non-selective anti-inflammatory drugs following a review of cardiovascular data. This is a separate review from that of the COX-2 inhibitors, which concluded in June, but threw up the need to assess the safety of non-selective NSAIDs such as ibuprofen, naproxen and diclofenac, as well [[28/06/05a]].
The European Commission requested the review in June and, following an assessment of heart attack and stroke risk, does not recommend any changes to the current advice given to patients and doctors. However, it has reiterated that patients should take the lowest effective dose for the shortest time necessary, and that prescribing should be based on the NSAID’s overall safety profiles and individual risk factors.
The CHMP is also reviewing data on gastrointestinal safety and serious skin reactions amongst non-selective NSAIDs and will unveil its overall decision in September.
