OOPS!

Celebrex risk alarms arthritis sufferers (Carolyn Abraham, Globe and Mail, December 18th, 2004)

Thousands of Canadians who rely on a new generation of painkillers have been left in medical limbo after the world's biggest drug maker warned yesterday that yet another blockbuster medication may pose serious safety risks.

Just three months after the popular arthritis and pain medication Vioxx was pulled off the market for increasing the risk of heart attacks and strokes, Pfizer Inc. announced that Celebrex, the drug billed as the safe alternative, had been suspended from use in a clinical trial after it too was found to raise the risk of cardiovascular problems and deaths when taken at high doses.

Canadians filled nearly three million prescriptions for Celebrex last year. The drug has been taken by an estimated 26 million people worldwide, usually for arthritis, but also for pain linked to everything from sprains to tendinitis. Many have switched to the medication since Vioxx, made by Merck & Co., vanished from pharmacies after Sept. 30.

At the same time, the New England Journal of Medicine released a report yesterday that calls for clinicians to stop prescribing Pfizer's Bextra, another popular new-generation painkiller, on the grounds that it too may increase "cardiotoxicity."

Together, the new developments are fuelling growing concern that this entire new class of anti-inflammatory medications known as COX-2 inhibitors, which were initially touted as wonder drugs of the biotech age, may simply be bad news for the heart. They are also bound to raise further concerns about the regulations that bring new drugs to market and how well they're monitored once they hit the shelves.

Health Canada itself acknowledged in a statement yesterday that "there has been a lack of published safety data regarding use for longer than one year of selective COX-2 inhibitor (drugs)" including Bextra, Mobicox and Celebrex, whose generic name is celecoxib. Based on the information available, Health Canada said there may indeed be an increased cardiovascular risk linked to these medications, particularly in patients who have other heart disease risk factors, such as high blood pressure, high cholesterol, smoking or diabetes.[...]

The U.S. National Institutes of Health said in a statement that it suspended the use of Celebrex after discovering that patients taking the drug during a long-term cancer study faced a 2.5-fold increase of "major fatal and non-fatal cardiovascular events," compared to those taking a placebo. Health Canada's Vlk noted that the risk climbed to an increase of 3.4-fold when the dose rose to 800 milligrams.

Perhaps the folks who have been ingesting all this stuff will take comfort in seeing proof that science is self-correcting.