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New Test Stirs Fears Over Safety of Celebrex A Local Expert Says Right Dose is Key

Posted on: Friday, 17 December 2004, 18:00 CST

Pfizer Inc. on Friday reported an increased risk of heart problems among patients taking high doses of its popular painkiller and arthritis drug Celebrex.

But an Omaha arthritis expert said people who take recommended doses of the drug have little cause for concern.

For arthritis sufferers, it's been a frustrating year.

Celebrex is in the same class as Vioxx, which was pulled from the market in September because of safety concerns; and Bextra, which is getting new warning labels about its use in patients who've recently had heart surgery.

But Dr. James O'Dell, chief of rheumatology and immunology at the University of Nebraska Medical Center, said the Celebrex concerns stem from experimental uses of the drug at doses two to four times the 200 mg or less daily dose recommended for most patients.

"We have a vast amount of data on Celebrex that's been accumulated from double-blind clinical studies and very large observational studies that have looked very closely at the heart," said O'Dell, a nationally recognized rheumatoid arthritis expert.

"And all of the studies have pretty much concluded that there isn't a significant problem. But with all of these products, if we start to use doses that are on the high end, we start to lose advantages associated with them and get into trouble."

O'Dell's advice for people taking Celebrex: "They should take Celebrex at 200 mg a day or less, not get scared about this, and discuss this with their physician when they have their next visit."

Pfizer said it found the increased risk for Celebrex in one of two long-term trials testing the drug's effect on preventing colon cancer. Celebrex is currently approved for use in the United States for the treatment of arthritis and pain.

Pfizer gave no indication Friday that it would pull Celebrex from the marketplace.

The National Cancer Institute conducted the study for Pfizer. The NCI stopped giving patients the drug after finding those taking 400 mg to 800 mg of Celebrex daily had 2.5 times greater risk of major heart problems than those who were not. A separate cancer study found no increased heart risk with patients taking 400 mg of Celebrex per day.

Earlier this month, the Food and Drug Administration said it was adding a warning to the labels of another Pfizer drug, Bextra. The FDA noted potential heart problems associated with the use of that drug in people who recently had heart-bypass surgery.

Bextra, Celebrex and Vioxx are in a class of pain drugs called cox-2 inhibitors. The drugs have become popular because of their effectiveness in treating the pain of arthritis and other ailments and their ease on the stomach.

Merck & Co. pulled Vioxx from the market Sept. 30 after a study indicated it doubled the risk of heart attacks and stroke when taken for longer than 18 months.

Studies done five years ago -- when Celebrex and Vioxx were approved -- suggest the same mechanism that inhibits inflammation and makes the drugs easier on the stomach also blocks a substance that prevents heart problems, scientists have said.

The withdrawal of Vioxx has been a financial and public- relations disaster for Merck. Its legal liabilities are estimated at up to $18 billion, and its shares have dropped by nearly one-third since the recall announcement was made in late September.

Vioxx had been a blockbuster drug for Merck, it's No. 2 earner with annual global sales of $2.5 billion. Some 2 million people worldwide had been taking Vioxx.

In the nine months ending in September, worldwide sales of Celebrex more than doubled from the same period a year earlier to $2.29 billion.

Dr. Joseph Feczko, president of worldwide development for Pfizer, noted that the results in the trial finding increased risk of heart attacks were not consistent with either the other cancer-prevention trial or with a "large body of data'' that the company had collected.

"Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world,'' Pfizer's chief executive Hank McKinnell said in a statement.

O'Dell said that he hopes drug makers and patients don't overreact to such findings and that they weigh the relative benefits against the risks of any drug.

"There's a lot of people out there who are suffering now because they don't have their Vioxx," said O'Dell, who explained that for some arthritis sufferers, Vioxx had been the best option. "If this gets out and scares people away from taking Celebrex, there's going to be other people who suffer."

This report includes material from the Associated Press.

Source: Omaha World - Herald

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