Increased Health Risks Linked To High Doses of CelebrexDec 19, 2004 | Star Tribune
Celebrex, the most widely prescribed pain killer for arthritis, increases the risk for heart attacks and strokes when taken at high doses, federal health officials said Friday.
Pfizer, Inc., which makes Celebrex, has no plans to pull what is one of its most profitable drugs from the market as competitor Merck & Co. did with Vioxx in September after it was linked to similar health problems. Pfizer said the findings are preliminary and have not been found in other studies.
But those taking the drug should check with their doctors, and, if possible, doctors should prescribe something else for them, federal health officials said Friday.
The announcement was the latest blow against a class of drugs taken by millions of people to control inflammation and pain from arthritis and other illnesses with fewer stomach problems and a lower risk of ulcers than from over-the-counter pain-relievers. Earlier this month Bextra, the third-largest seller, was found to pose a greater risk for patients who recently had heart bypass surgery.
"We have great concerns about this product and the class of these products," said Dr. Lester Crawford, acting Food and Drug Administration (FDA) commissioner. "We do not have a decision on the fate of the product."
Since over-the-counter drugs such as Advil, Aleve and even aspirin are just as effective in controlling pain, patients especially those with heart disease should try to find other alternatives, said Dr. Tom Raya, a cardiologist at United Hospital in St. Paul.
Celebrex, Vioxx and Bextra, called Cox-2 inhibitors, were developed because they cause less stomach upset and carry a lower risk for ulcers than the standard over-the-counter pills, he said.
Franz Eisenbauer, 68, of Plymouth, had taken Vioxx for three years before switching to Celebrex on his doctor's orders a few weeks ago. He has rheumatoid arthritis and took the prescription medications because Advil and other over-the-counter medications gave him stomach problems, he said.
Celebrex didn't work as well as Vioxx to control his arthritis pain, he said, and now he may have to find something else.
"But you have to live with it," he said.
Pfizer officials said the increased risk for Celebrex showed up in one of two long-term trials that tested Celebrex as a treatment for colorectal cancer. It showed that patients taking very high doses of 400 to 800 milligrams a day had 2.5 to 3.4 times higher risk of heart attack and stroke compared to patients who were not taking it. The second trial, in which patients were taking standard doses of 400 milligrams or less, showed no increase in risk, Pfizer said.
The rate of heart attacks and strokes in the Celebrex study was low 2.2 to 3 percent depending on the dose, health officials said. Yet that compared to a rate of less than 1 percent for those taking a placebo, they said.
Dr. Marie Griffin, an epidemiologist and drug safety expert at Vanderbilt University, in Nashville, said the findings on Celebrex are worrisome evidence suggesting that all Cox-2 drugs have similar risks.
However, she noted that the study tested 400 to 800-milligram doses four times the usual dose and that the safety problem may not exist at lower doses.
"What this means for people who have heart disease is it's best to avoid these drugs," she said.
At a telephone news briefing Friday, top officials from the National Institutes of Health (NIH) and the FDA said patients taking Celebrex in another ongoing cancer study of equal size showed no increased risk. Earlier studies of the drug suggested that it might even protect against heart attacks, officials said.
Nonetheless, federal officials said they have halted the cancer trials and plan to study the data further.
Celebrex is the most-prescribed drug for treating arthritis. In the nine months ending in September, worldwide sales more than doubled from the same period a year earlier to $2.29 billion, accounting for 6 percent of Pfizer's total sales of $37.59 billion.
In releasing the study's findings, Pfizer Chairman Henry McKinnell said in a statement that the company wanted to "rapidly communicate new information to regulators, physicians and patients around the world."
Pfizer's stock price dropped nearly 11 percent Friday, closing at $25.80.
The withdrawal of Vioxx has been a financial and public relations disaster for its manufacturer, Merck & Co., in part because the company has been accused of muzzling news about the drug's side effects. Its legal liabilities are estimated at up to $18 billion, and its shares have dropped by nearly one-third since the recall was announced in late September.
Earlier this month, the FDA said it was adding a warning to the labels of Bextra, also made by Pfizer.