NSAID warnings to change after adverse findings

A full review of diclofenac was launched in 2013 after earlier TGA safety reviews raised concerns about the drug’s hepatotoxicity and its higher cardiovascular risks than traditional NSAIDs.

While the link between prescription diclofenac and hepatotoxicity was already known, over-the-counter (OTC) versions of the drug also posed these risks, the TGA announced today.

The administration has recommended that doctors be aware of these dangers, and that packages should now include the notice: “Warning: In rare cases, diclofenac has been associated with serious liver injury.”

Despite the cardiovascular and hepatotoxic risks, the TGA’s safety review ultimately regarded the use of prescription, OTC and topical diclofenac as favourable.

Individual assessment of CV risk, appropriate supervision and greater patient awareness of potential risks were encouraged when prescribing diclofenac, naproxen, ibuprofen, celecoxib,