NSAID labelling review
The TGA has announced it will be reviewing product information and labelling for non-steroidal anti-inflammatory drugs.
The review will include diclofenac, naproxen, ibuprofen, celecoxib, etoricoxib, indomethacin, meloxicam and piroxicam.
These changes follow from a review of the cardiovascular risks associated with the use of these medicines and a full safety review of diclofenac.
While use of NSAIDs at prescription-only dosages was already known to increase the risk of high blood pressure, heart failure, myocardial infarction and stroke, the TGA review found that these risks also applied to oral diclofenac, naproxen and ibuprofen available OTC.
Similarly, the risk of hepatotoxicity in relation to use of prescription diclofenac was known, but the diclofenac safety review found that oral products available OTC also carried this risk.
The reviews found that use of OTC NSAIDs was safe when they were used according to the recommended doses for short durations, as instructed on the label.
“However, inappropriate use or overuse of these medicines could pose a significant risk of cardiovascular events and, in the case of diclofenac, hepatotoxicity”.
Health professionals should “consider advising patients of the increased cardiovascular risks of using NSAIDs, including OTC products, and educating them regarding the signs and symptoms of serious cardiovascular events,” the TGA advises.
“Be aware that, in rare cases, diclofenac has been associated with a risk of hepatotoxicity and should be used at the lowest effective dose for only short periods of time”.
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