Over-the-counter NSAIDs will carry warning labels saying that they may increase the risk of heart attack and stroke, the TGA says.

From July 2016 labels will be required to include an additional statement that will say: “Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage.”

The TGA rejected proposals to reschedule NSAIDs to pharmacist-only medications on the basis of their cardiovascular risk.

The cardiovascular and hepatotoxicity risks associated with NSAIDs do not apply to topical NSAIDs and no changes need to be made to their availability, scheduling or labelling.