Heart attack, stroke: popular painkillers to carry health warnings after 2016

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The warnings will state ‘excessive use can be harmful and increase the risk of heart attack, stroke or liver damage’.

Some of Australia’s most popular painkilling medications will carry warnings from next year that they could put people at risk of heart attack and stroke.

The medications, which contain the active ingredients ibuprofen, diclofenac and naproxen, are freely available at the chemist and supermarket under brand names such as Nurofen, Advil and Voltaren.

Health authorities stopped short of the more radical actions of other countries such as the UK, where diclofenac has been made prescription-only.

Earlier this year, US health authorities warned even a few weeks of using the drugs could increase a person’s risk of a fatal heart attack.

Australia’s Therapeutic Goods Administration (TGA) has been reviewing the safety of the drugs against the back of increasing reports of dangerous cardiovascular complications.

In 2010, Fairfax Media reported that the drugs had been linked to stroke and some experts believed they should be banned or sold only on prescription.

The TGA said its review found the medications were “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, [liver toxicity],” it said.

The drugs are a type of medicine known as a “non-steroidal anti-inflammatory” medications. Another of this class of drugs, the arthritis drug Vioxx, triggered a $4.85 billion lawsuit amid evidence it doubled the risk of heart attack for patients, causing as many as 140,000 in the US alone.

All forms of ibuprofen, diclofenac and naproxen will now carry a warning that using them at high doses can increase your risk of high blood pressure, heart attack, heart failure and stroke.

The warning will state: “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.”

Most medications will be expected to carry the label by July 2016, although some have been given an extension until January 2017.

The Australian Self Medication Industry supports the changes to the warning labels, however, Alphapharm, which makes non-brand name generic versions of medicines, said while warnings on packets were sufficient for medications sold in pharmacies because of the quality of information provided by pharmacists, product inserts were needed when the drugs were sold at supermarkets to make sure consumers were properly informed.


Henry Sapiecha

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