EMEA Will Evaluate All NSAIDs In Search Of Potential “Class Effect”
This article was originally published in The Tan Sheet
Executive Summary
The EU health authority will undertake its own review of all non-steroidal anti-inflammatory drugs in light of safety concerns surrounding COX-2 inhibitors
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The EU health authority will undertake its own review of all non-steroidal anti-inflammatory drugs in light of safety concerns surrounding COX-2 inhibitors. The Committee on Medicinal Products for Human Use (CHMP) "has now decided to look at the safety profile of NSAIDs to determine the need for further steps," the European Medicines Agency (EMEA) said June 27. The action follows FDA's recent announcement on labeling changes for NSAIDs in the U.S. The agency requested that makers of OTC ibuprofen, naproxen and ketoprofen add a statement on cardiac risk and prominently display "NSAID" on packaging in a June 15 letter (1 (Also see "Requested OTC NSAID Labeling Includes Cardiac Risk, Front Panel Changes" - Pink Sheet, 20 Jun, 2005.), p. 5). FDA, which simultaneously expanded warnings for COX-2s, based the nonprescription warnings on a suspected NSAID "class effect" on the risk of cardiovascular and gastrointestinal adverse events. It appears EMEA also is concerned that safety issues for COX-2s may apply to the NSAID class as a whole. The CHMP previously compared COX-2 inhibitor safety with that of conventional NSAIDs and is conducting the NSAID review "on the basis of these data," EMEA noted. A request from the European Commission also is driving the NSAID review. EMEA acknowledged that the class effect remains an open question. "It is unclear if the findings for COX-2 inhibitors are also relevant for conventional NSAIDs," the agency said. However, caution is advised until the review is completed. "Pending any future recommendations, healthcare professionals and patients should closely follow the product information for conventional NSAIDs (whether prescription or nonprescription) and COX-2 inhibitors." The NSAID review was announced following a CHMP meeting June 20-23, during which the committee also recommended new contraindications and warnings for COX-2 inhibitors on the market in the EU. The committee advised doctors "to use the lowest effective dose for the shortest possible duration of treatment" and stated that COX-2s should not be used in patients with established ischemic heart disease or cerebrovascular disease. |