AUSTRALIA'S drug safety regulator says it is closely monitoring the use of two widely used painkillers that have been linked to a heightened risk of stroke.
The Therapeutic Goods Administration (TGA) said today it was monitoring the use of drugs containing diclofenac, and ibuprofen, following the release of a study showing their impact on the Danish population.
The research, which took in painkiller use among 5.5 million Danes and over eight years, showed diclofenac could increase an otherwise healthy user's stroke risk by 86 per cent.
Ibuprofen - another compound commonly used in non steroidal anti-inflammatory drugs - was linked to a 30 per cent increased risk of stroke when daily doses exceeded 1200 milligrams.
"The TGA is aware of cardiovascular concerns as a possible side-effect (and) continues to closely monitor these medicines," a TGA spokesperson said in a statement.
Voltaren is one widely used diclofenac-containing pharmaceutical but TGA records show there are 71 different products, more than half prescription only or made for export.
Nurofen and Advil are common and widely-used painkillers containing ibuprofen.
The spokesperson said the TGA had received no reports of adverse events associated with ibuprofen.
It had received eight reports of heart attack, and one of angina, associated with diclofenac use but "in only two of these was diclofenac the sole suspected medicine".
"The TGA advises that the lowest effective dose should always be used for the shortest possible duration with these medications," the spokesman said.
The TGA also said the drugs did carry appropriate warnings and, when sold over the counter, they were "of a low dose available in small packs".
The Danish study has lead to calls for ibuprofen to be made a prescription-only and for diclofenac medicines to be banned.
Novartis Australia, maker of Voltaren, said the research findings did not change the "benefit to risk assessment" for diclofenac and users should discuss any concerns with their doctor or pharmacist.
"Diclofenac medicines ... have been used in millions of patients since they first became available 30 years ago," Novartis Australia spokesman Matthew Cuming said.
"In the context of extensive worldwide clinical experience with diclofenac, we do not believe this Danish study changes the benefit to risk assessment ... when used as directed."
Reckitt Benckiser, maker of Nurofen, said the Danish study assessed the impact of high doses of ibuprofen and this should not be confused with non-prescription low doses.
The maximum dose recommended for ibuprofen drugs available over-the-counter was 1200 milligrams per day, said Dr Phil Berry, global medical director of Reckitt Benckiser Healthcare International.
"There is no clinical evidence to suggest that consumers need to be concerned about their safety in relation to an increased risk of cardiovascular events when taking non-prescription ibuprofen products," Dr Berry said.
Originally published as TGA on alert as ibuprofen linked to strokes