A range of popular painkillers will have to carry new warning labels saying they can increase the risk of heart attack and stroke.
The Therapeutic Goods Administration (TGA) reviewed the safety of anti-inflammatory drugs such as ibuprofen, naproxen and diclofenac as well as newer anti-inflammatory drugs known as Cox-2 inhibitors.
After considering submissions from health experts and the drug manufacturers, labels will be updated to say: “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.”
Health authorities 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.
Health authorities reviewed the safety of eight non-steroidal anti-inflammatory drugs (NSAIDs): diclofenac, naproxen, buprofen, celecoxib, etoricoxib, indomethacin, meloxicam and piroxicam.
The TGA concluded that other similar anti-inflammatory drugs such as ketoprofen and mefenamic acid probably pose the same heart and liver risks, so they will also need new warning labels.
The current labels on all the anti-inflammatory drugs state that “excessive use can be harmful”.
The labels will be introduced in July 2016.