Arthritis drug showdown proves a pain for patients

Exasperated doctors are heading for a showdown with drug safety agency Medsafe after it told thousands of arthritis sufferers to stop taking a popular anti-inflammatory drug.

Medsafe has announced that the cardiovascular risks from the Cox-2 inhibitors outweigh their benefits.

Another arthritis drug, Vioxx, was withdrawn in October.

It is likely the Cox-2 inhibitors will be withdrawn after a meeting of the Medicines Adverse Reactions Committee on March 15.

An estimated 60,000 New Zealanders have taken Cox-2 inhibitor drugs over the past year.

New Zealand Rheumatologists Association president Andrew Harrison said Medsafe's advice was a knee-jerk reaction and taking Celebrex, Arcoxia, Bextra, Dynastat and Mobic off the market would hurt a lot of people.

"What is being overlooked is these are drugs of last resort and they're expensive. You don't use it out of fashion. You make sure you really need it.

"Some people shouldn't be using it - those who are obese, smokers, middle-aged with a family history of heart disease. People at low risk, even if you double it, it's still a low risk."

With the best of intentions, Medsafe had looked at the data but made a few errors in judgment.

"They've said we haven't got proof that it's safe in anybody, so we're going to take it that it's unsafe, which is not really valid," Dr Harrison said.

"They've over-interpreted the data and gone too far with it.

"Options were limited for those relying on Cox-2 inhibitors. You can't tell them to take an anti-inflammatory with a stomach-protecting pill, because they've already done that.

"Ultimately, these drugs will still be available through other sources, but it will mean paperwork, and the cost may go up if the market shrinks."

Dr Harrison was puzzled by Medsafe's announcement as it was made several days after health advisers in the United States gave Celebrex and Vioxx a clean bill of health.

Last year a US study of anti-inflammatory drug Vioxx showed the drug could more than double the risk of heart attacks and strokes.

But Merck & Co's drug may return to the market after the US Food and Drug Administration advisory panel narrowly voted it was safe enough to be sold despite an increased risk of heart attack and stroke.

Pfizer's rival pain relievers, Celebrex and Bextra, which had also been under a cloud over elevated risks of heart problems, were also safe enough for sale, the FDA said.

It was a stunning turnaround for Vioxx, withdrawn in the US in September.

"After the announcement in the US, Medsafe had the chance to reassess the data, yet they still went ahead with it," Dr Harrison said.

"It seems odd they've taken this response."

The Rheumatologists Association is preparing a response to Medsafe, to counter some of its arguments and to advocate on behalf of patients.

Dr Harrison said Medsafe had focused on the risks, not on the benefits.

"I don't think many of them [Medsafe doctors] are practising in the musculo-skeletal area and perhaps have underestimated the effect of pain on arthritis sufferers and the impact on their ability to function.

"It would be great if Vioxx was restored because it is a very powerful drug for people at low risk of heart problems.

"It was just brilliant and a lot of people suffered greatly when it was taken away."

A Medsafe spokeswoman declined to comment on Dr Harrison's views.

Lower Hutt GP Mark Austen, who is also a naturopath, agrees with Dr Harrison. He said more people would look for alternative treatments.

"There's still an extensive range of drugs, but Vioxx and Celebrex had less gut side-effects. There's now less choice of drugs with fewer side-effects."

Dr Austen said people had already started looking for alternative drug treatments.

- NZPA