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Regulator takes tough action on arthritis drugs (*amended)

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Media statement

25 February 2005

*This amended version replaces the version placed on the TGA website on 10 February 2005. An error about the relationship of parecoxib to valdecoxib has been corrected.

Australia's medicines watchdog, the Therapeutic Goods Administration (TGA) has introduced tough new measures on the prescribing of anti-arthritis drugs known as Cox-2 Inhibitors following the findings of a review into the safety of this family of medicines.

In September last year the popular arthritis drug, Vioxx, was withdrawn from the market world wide because medical trials had shown a significant increased risk of heart attacks and strokes.

In response, the TGA undertook urgent evaluations of new information provided by the sponsoring pharmaceutical companies of all other registered Cox-2 inhibitor drugs.

The results of this review were considered by the Australian Drug Evaluation Committee (ADEC) which made a number of recommendations to restrict the use of these drugs in Australia.

As a result, the TGA will immediately require manufacturers of Cox-2 inhibitors to place new highlighted explicit warnings in product information about the increased risk of cardiovascular adverse events from this group of drugs. The new warning statements are to be highlighted with a black boxed margin.

The TGA is also advising people who are taking more than 200mg a day of celecoxib (Celebrex) or more than 15 mg a day of meloxicam (Mobic;Movalis) to review their treatment regime with their doctors.

"While most Australians using these drugs will be taking low doses that already meet this dosage advice, some patients, particularly with rheumatoid arthritis or a rare bowel condition, may be taking 400 mg or 800 mg of celecoxib a day and some patients with arthritis may be taking more than 15 mg of meloxicam a day," Dr John McEwen, the Principal Medical Adviser of the TGA, said today.

"Unfortunately this recommended dose reduction may result in some patients with arthritis having increased symptoms but the review of Cox-2 inhibitors clearly indicated there is an increased risk of heart attacks and strokes with high doses of these drugs," Dr McEwen said.

Professor Martin Tattersall, Chair of ADEC, said the Committee reviewed evidence of six drugs in the Cox-2 inhibitor family, all of which were considered to have risks associated with their use.

"The exact size of the risk and the exact duration of therapy associated with increased risk are still unknown, and so we have recommended that Cox-2 inhibitors should be prescribed only when other treatments cannot be tolerated or have caused serious adverse effects."

"In addition celecoxib and meloxicam should not be prescribed for patients with increased risks of cardiovascular events such as heart attacks and treatment should be limited to the shortest time needed," Professor Tattersall said.

The supply of both celecoxib and meloxicam is subsidised by the Pharmaceutical Benefits Scheme.

The new requirements reinforce and extend advice given to Australian heath care professionals in the Australian Adverse Drug Reactions Bulletin, October 2003 and repeated in December 2004.

The TGA has also accepted a number of other recommendations of ADEC and has given notice to the relevant companies:

  • it is proposed to cancel the registration of the drug parecoxib (Dynastat) because of the risk of cardiovascular events. Dynastat is marketed in Australia and is approved as a single dose at the time of surgery to reduce post-operative pain. Parecoxib is converted to valdecoxib in the body.
  • it is proposed to withdraw the indication of management of arthritis of the drug valdecoxib (Valdyne,Dynoral-known in some countries as Bextra). Valdecoxib has not been marketed in Australia. Valdecoxib has been associated with an increased risk of cardiovascular events in cardiac by-pass graft patients. The use of Valdecoxib for 5 days as an analgesic in patients without increased cardiovascular risk will remain.
  • it is proposed to greatly limit the approved uses of two other Cox-2 inhibitors which have not yet been marketed in Australia. They are etoricoxib and lumiracoxib. In both instances, ADEC was not sufficiently assured of the safety of these drugs for anything other than short term use in patients without increased cardiovascular risk.

People who are concerned about their use of Cox-2 Inhibitors should discuss their treatment with their medical practitioner.

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

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