The Therapeutic Goods Administration (TGA) has introduced new restrictions on the anti-arthritis drug, Celebrex.
The drug, which is taken by 300,000 Australians, has been found to increase the risk of heart problems.
In September last year, the anti-arthritis drug Vioxx was taken off the market because it was found to increase the risk of heart attack.
A TGA review of Celebrex has resulted in the manufacturers being told to put warnings on their product information.
Chair of the Australian Drug Evaluation Committee, Professor Martin Tattersall says people taking high doses of the drug should review treatment with their doctors.
“The risk is something which now has changed the balance in favour of reducing the use of this drug by dose and reducing the duration of drug treatment,” he said.
Professor Tattersall says the drug should only be prescribed when alternative therapies are found to cause serious side-effects.
Pfizer, the Australian manufacturer of Celebrex, says it has received the decision on the proposed changes.
A spokesman says the company strongly disagrees with the decision.
He says it is holding discussions with the TGA and considering an appeal.