Stronger warning for popular painkillers

By Corin Kelly
Thursday, 19 November, 2015

Following a review by the Therapeutic Goods Administration (TGA), a range of popular painkillers will carry a stronger warning, alerting users to the potential for increased risk of heart attack, stroke and in the case of diclofenac, liver toxicity.
The reviews covered eight non-steroidal anti-inflammatory drugs (NSAIDs): diclofenac, naproxen, ibuprofen, celecoxib, etoricoxib, indomethacin, meloxicam and piroxicam.
Use of over-the-counter (OTC) NSAIDs is safe when they are used according to the recommended doses for short durations, as instructed on the label. However, inappropriate use or overuse of these medicines can pose a significant health risk.
It was found that the current product labelling for OTC diclofenac, naproxen and ibuprofen does not carry adequate warnings regarding the risks of adverse cardiovascular events or diclofenac-related hepatotoxicity.
Submissions from 11 health experts and drug manufacturers were considered by the TGA and the decision was made to change the labelling to read,

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 of the drugs can be harmful and increase the risk of heart attack, stroke or liver damage.

The TGA decided against making the drugs available only by prescription.
"The addition of stronger warnings on the labels should be sufficient to alert and inform consumers about the risks associated with excessive use of those products," the TGA said.
The TGA said the heart and liver risks associated with anti-inflammatories do not apply to anti-inflammatory creams so their labels do not have to be changed.
The TGA has also worked with manufacturers of prescription-only and pharmacist-only NSAIDs to ensure that their Product Information (PI) documents are amended to reflect the conclusions of the reviews.
The new labels will be introduced from July 2016 to Jan 2017.
Reference: TGA. Review of cardiovascular safety of non-steroidal anti-inflammatory drugs and Safety review of diclofenac.