Ibuprofen advice under review: TGA

The Therapeutic Goods Administration has rejected a recommendation to review the sale of all pain relieving medications sold over the counter.

Reviewing the sale of all over-the-counter painkillers because of fears ibuprofen use will cause cardiac arrest would be impractical, the Therapeutic Goods Administration says.

The TGA's Dr John Skerritt has told a Senate inquiry hearing in Canberra its officers were reviewing a Danish study that found non-steroidal anti-inflammatory drugs (NSAIDs), including ibuprofen - commonly sold as Nurofen or Advil - were associated with a 31 per cent increased risk of a cardiac arrest.

However when asked by Labor senator Murray Watt on Friday, Dr Skerritt said he didn't believe a rethink on the sale of all pain-relieving medications was necessary, .

"That's a very big call, all over-the-counter pain medications, that's an awful lot of pain medications that many, many patients benefit from on a regular basis without any sort of adverse events," he said.

"It seems like a pretty broad recommendation and probably one that's not very practical."

According to the 10-year Danish study published in European Heart Journal - Cardiovascular Pharmacotherapy, the risk of cardiac arrest was greatest among those who used diclofenac (51 per cent) commonly sold as Voltaren.

While ibuprofen was associated with a 31 per cent increased risk.

It's thought NSAIDs can cause constriction of arteries that control blood flow to the heart, blood clotting and a rise in blood pressure.

Chief medical officer at the Australian Heart Foundation, Professor Garry Jennings, said the findings support accumulating evidence that these drugs carry a real risk for the heart.

"In absolute terms this is a relatively small risk but it seems to be fairly real," Professor Jennings told AAP.

The risk appeared to be only for those with a pre-existing heart condition, he noted.

Despite this, Professor Jennings said he believed there was a case for a review of all painkillers, including NSAIDs, bought over-the-counter.

"There is an assumption that if you can buy something anywhere, then they must be safe and we know these drugs are not safe, this is not the only problem associated with them," he said.

Dr Skerritt of the TGA acknowledged on Friday the new study on NSAIDs was concerning but said Australia is already "ahead of the game" when it comes to alerting patients to their possible dangers as a result of a 2014 review on these drugs.

However he said, if any "urgent" new evidence comes to light then the TGA would change it's position.

For the moment people just need to follow the instructions that come with the pain medicines, Dr Skerritt said.

"The instructions with he medicine is the most current advice we have available and until we see a need, a clinical need, a medical need to make a change it's probably best to stick with the advice currently available."


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Source: AAP


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Ibuprofen advice under review: TGA | SBS News