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News of Celebrex's Increased Heart Risk Leaves Regulators Scrambling

Posted on: Friday, 17 December 2004, 15:00 CST

TORONTO (CP) - Health authorities were left scrambling Friday when the company that makes one of the world's most popular pain relievers admitted Celebrex appears to increase the risk of heart attack in users.

Pfizer Inc., which informed Health Canada of the finding Friday, announced it had no plans to pull the drug from the market, as competitor Merck did in September when it revealed Vioxx, another wildly popular drug in the same class, doubled users' risk of heart attack.

Health Canada spokesperson Jirina Vlk said officials with the department were in discussions with Pfizer to learn more about the finding.

Regulatory authorities will use the information learned in those discussions to determine what if any action to take, Vlk said.

In the meantime, Vlk offered this advice to users of the drug: "If people are concerned, they should . . . discuss any concerns they have with their health-care provider."

Adding to Pfizer's woes, the New England Journal of Medicine rushed to print Friday a letter from three U.S. researchers calling for a virtual moratorium on sales of Bextra.

Bextra is the brand name for a drug called valdecoxib. Made by Pfizer, it is from the same class of drugs as Vioxx and Celebrex, drugs known as cox-2 inhibitors.

"To protect the safety of the public, we write to recommend that clinicians stop prescribing valdecoxib except in extraordinary circumstances," said Wayne Ray, Marie Griffin and Michael Stein of Valderbilt University School of Medicine.

The trio cited two trials which showed that when used in patients immediately after coronary bypass surgery, Bextra increased the risk of serious cardiovascular events three-fold.

Two of the authors - Ray and Griffin - disclosed to the journal they had previously received consulting fees and research support from Pfizer and Merck.

Cox-2 inhibitors stormed the market when they were introduced a few years ago.

Makers of the drugs claimed that they offered better relief of pain caused by conditions like arthritis, but were less likely to cause the bleeding ulcers that can be caused by continued use of older and less expensive pain medications.

But even before Vioxx's abrupt withdrawal, longer term data from trials of the drugs suggested they were not more protective against gastric bleeds.

When Merck pulled Vioxx, many researchers argued the heart risks it provoked were not unique to it, but were associated with the entire class of drugs.

Source: Canadian Press

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