NSAID Panel Highlights Challenge Of Getting Comparative Safety Claim

Does wide public health concern warrant flexibility in regulatory standards for safety claims? Advisory panel on cardiovascular risk of NSAIDs spotlights dual challenge of accurately determining drug risks and communicating risks in informative way.

FDA convened its advisors for input on whether labeling for non-steroidal anti-inflammatory drugs needs to be updated to reflect differential cardiovascular risk among drugs in the class, despite acknowledging that it would be unprecedented to provide a comparative safety claim based on the level of evidence – meta-analysis and observational data – currently available.

Just making that assessment alone seems a daunting task, but the panel discussion also highlighted the difficulty of conveying subtle...

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