All NSAIDs available over the counter will be required to carry a hepatotoxicity warning, the TGA has said.
The announcement comes in response to submissions received to its proposed changes to the safety labelling of over-the-counter NSAIDs diclofenac, flurbiprofen, ibuprofen, ketoprofen, mefenamic acid and naproxen.
A confidential submission noted that liver damage was a documented side effect of all non-steroidal anti-inflammatory drugs (NSAIDs), not just diclofenac.
It proposed that the hepatotoxicity risk associated with excessive use of diclofenac should be included on the labelling of all OTC oral NSAID products.
“Consequently, the TGA will require the additional words “…or liver damage” for all of the OTC oral NSAID labels,” the TGA said in its response.
However the TGA did not agree that paediatric-specific products should be exempt from the requirements.
“Children may use these medicines long-term and/or at higher doses for relief of pain of conditions such as juvenile arthritis,” it said.
The wording ‘excessive or prolonged use’ originally proposed in the consultation (in place of ‘excessive use’) will not be required, provided the medicine label includes the full three-sentence statement.
“Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage“.