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Arthritis drugs put on urgent review
By Ruth Pollard, Health Reporter

December 29, 2004 - The medicines watchdog is under increasing pressure to recall two anti-inflammatory drugs after safety warnings from the US and the voluntary withdrawal of advertising by the drugs' maker, Pfizer. The new-generation drugs used to treat arthritis, Celebrex and Bextra, were the subject of a public health advisory from the US Food and Drug Administration late last week. It follows Pfizer's announcement a fortnight ago that a clinical trial had shown Celebrex could carry an increased risk of heart attack and stroke.

Another drug in the Cox-2 inhibitor class, Vioxx, was suddenly withdrawn from the market by its manufacturer, Merck, on September 30 because of evidence it increased the risk of heart attack and stroke.

The US agency advised that doctors should prescribe the two drugs only to patients with a history of gastrointestinal bleeding, or to those whose pain was not controlled with other drugs. It said doctors should evaluate patients' risk of heart disease before prescribing a Cox-2 inhibitor.

At least 300,000 arthritis sufferers around Australia were affected by the withdrawal of Vioxx. It is unclear how many take the other two drugs in that class. After Vioxx was withdrawn from the market, the senior medical director of Pfizer Australia, Bill Ketelbey, said the firm was "confident in the long-term cardiovascular safety of Celebrex, based on a large body of clinical evidence". Celebrex's chemical composition is similar to that of Vioxx.

But while Celebrex remains on the market, Pfizer has voluntarily withdrawn its consumer advertising in the US and New Zealand (direct to consumer advertising is not permitted in Australia).

Jon Jureidini, the chairman of Healthy Skepticism, a website that exposes pharmaceutical marketing techniques, said consumers could return to taking over-the-counter anti-inflammatory drugs - the "cheaper and safer alternatives". He said: "There is no reason to keep taking the risk with [these drugs]. I can't see a rational scientific basis for the [Therapeutic Goods Administration] refusing to withdraw them. The drug company involved has withdrawn its advertising ..." Dr Jureidini said the warning signs on that class of drugs had been there for four years.

The Therapeutic Goods Administration has asked all firms researching Cox-2 inhibitors to produce their results as a matter of urgency. It has instructed organisations conducting trials not to enrol any more patients and to discuss the new developments with existing trial participants. The administration said the report on the Cox-2 inhibitors was due to be completed in mid-January; in the meantime, it had advised doctors and consumers of the concerns about Celebrex.

The medical director of Arthritis Australia, Graeme Jones, said last week that there was no evidence that the Celebrex dose commonly prescribed to Australian patients, 200 milligrams, raised the risk of heart disease.

How safe is your pain medicine?

By: Capital News 9 web staff

There's more fear and confusion about yet another popular drug. This time it's the pain reliever Naproxen-- better known by one of its brand names, Aleve. It's been linked in one study to a possible increased risk of heart attack. And unlike Vioxx and Celebrex -- which are the subject of similar concerns -- Naproxen is available over the counter.

Lucy Pederson had a painful decision to make today. Should she keep taking Aleve? It really helped her headaches, but she was worried about a study that says it might cause heart attacks and strokes. Pederson said, "I took the bottle of Aleve that I carry in my purse every day, out of my purse this morning."

In the end, Aleve was out for her. Now she's thinking, what drug is safe to take? And so is her mother. Celebrex worked for her hip pain, but a study announced last week linked it too to heart attacks and strokes.

Pederson, her mother, and sister have come to this pain clinic in Manhattan for answers. Their doctor, Norman Marcus, said he's been bombarded over the past few days by questions about what drugs to take when fewer and fewer seem to be safe.

Dr. Norman Marcus, pain medicine specialist, said, "People are afraid. They're sad because a lot of times they got a great result from drugs that are now problematic."

Problems with pain relievers

With this bewildering flood of bad news about popular drugs, you might wonder, just what in your medicine chest is safe?

All this news about three blockbuster drugs, has caused a lot of people, well, a lot of pain. People even sent CNN emails asking for help. One man said: "I've been taking celebrex for 18 months. I have a family history of cardiovascular disease. What should I do?"

Barbara from NY asked: "My husband and I were on Vioxx for several years. We've gone to Celebrex. Now there are concerns about Celebrex. What now?" Dr. Marcus said It's tough for even physicians to know what to say when drugs they trusted for years turn out to have side effects. He said, "I think there should have been more information."

And that's what angers the Pedersons, they wonder why didn't someone see these dangers before?

Pederson said, "I just don't think they take long enough to really look into these medicines. I think it comes on the market too quickly."

Now the Pedersons are left searching for something else to treat their pain that won't, like Celebrex and Aleve, turn out years later to possibly have serious side effects.

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