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Potential safety risks with Celebrex

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Media statement

18 December 2004

Australia's medicine's watchdog, the Therapeutic Goods Administration (TGA) confirmed this morning that it had been informed by the US FDA overnight of some preliminary results from a long term research study using the popular arthritis drug, Celebrex that indicated there may be an increased risk of cardiovascular disease in people taking high doses of this drug.

The research was looking at a new use of Celebrex in preventing growth of colon polyps, and used up to twice the dose of the drug recommended for use in arthritis in Australia and four times the usual dose for which supply is provided in the PBS. The results of the research are preliminary at this stage, and are not consistent with two other long-term studies currently ongoing in which no cardiovascular concerns have been raised despite careful regular review of the data by independent data monitoring boards.

Since another arthritis drug in the same family, Vioxx, was withdrawn from the world market recently because of increased risks of cardiovascular disease, the TGA has been undertaking an exhaustive review of all Cox-2 Inhibitors, including Celebrex.

In its December bulletin to doctors, the expert committee advising the TGA on drug reactions, the Adverse Drug Reactions Advisory Committee, warned medical practitioners who prescribed Celebrex for their patients to ensure they had appropriate information about the patient's medical history, especially in relation to existing cardiovascular disease. The Bulletin also informed doctors of the safety review being undertaken by the TGA in to Cox-2 Inhibitors.

Although there has been no evidence of a problem with Celebrex, the ADRAC had advised that all drugs in the class of Cox 2 inhibitors should be regarded as having an increased cardiovascular risk until more is known. Over the last five years, while there have been over 15 millions prescriptions issued for Celebrex, there have been only 18 possible heart attacks reported, which is an average of less than four a year.

Today the TGA is working closely with the FDA, Pfizer, the manufacturers of Celebrex and the Australian Medical Association to analyse the new research, which is very preliminary at this stage.

People taking Celebrex should not stop taking their drug suddenly but should discuss any concerns with their doctor about continuing with the medication or changing to an alternative drug.

Media contact: Kay McNiece, Media Adviser to the TGA, 0412 132 585

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