Expert: Celebrex Still OK For People Without Heart Problems
New Study Suggests Popular Painkiller Carries Heart Risks
POSTED: 9:55 am EST December 17, 2004
UPDATED: 5:19 pm EST December 17, 2004
The drug manufacturer Pfizer says it will continue to sell the painkiller Celebrex despite a new study that finds an increased risk of heart problems when taking the drug.The company says there are no plans to pull the drug from the market.
Celebrex is in the same drug class as Vioxx, which was pulled from the market in September because of safety concerns.
The new information about Celebrex, a COX-2 inhibitor, is based on an analysis of two long-term cancer trials with a total of 3,600 participants, the company said. One of the studies found an increased risk of heart attacks in people using Celebrex compared to those using a placebo, while the other study found no increased risk with Celebrex.Dr. Marie Griffin, a drug-safety expert, said the study findings are worrisome, but people can continue using the drug -- as long as they don't have heart problems.Griffin, an epidemiologist at Vanderbilt University, noted that the study reporting the link looked at people using as much as four times the recommended dose. She said the safety trouble may be caused by high doses. Griffin said it's best for people with heart disease to avoid Celebrex and other COX-2 inhibitors. New York cardiologist Dr. Richard Hayes said he would recommend his patients switch from Celebrex to over-the-counter medicines such as Advil to treat their pain. The National Cancer Institute was conducting the study in question for Pfizer. It halted the trial after finding that patients taking 400 to 800 milligrams of the drug daily were 2.5 times more likely to have major heart problems."These clinical trial results are new. The cardiovascular findings in one of the studies are unexpected and not consistent with the reported findings in the second study," said Hank McKinnell, Pfizer chairman and chief executive officer. "Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world."Celebrex is approved for use in the United States for the treatment of arthritis and pain.Dr. Joseph Feczko, president of worldwide development for Pfizer, said patients using Celebrex should discuss appropriate treatment options with their doctors."Physicians should factor this new information, as well as ulcer risks and gastrointestinal bleeding seen with traditional NSAIDs, into their prescribing decision," Feczko said. Pfizer's stock has been sliding since the announcement.
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Video: More On Celebrex RisksThe new information about Celebrex, a COX-2 inhibitor, is based on an analysis of two long-term cancer trials with a total of 3,600 participants, the company said. One of the studies found an increased risk of heart attacks in people using Celebrex compared to those using a placebo, while the other study found no increased risk with Celebrex.Dr. Marie Griffin, a drug-safety expert, said the study findings are worrisome, but people can continue using the drug -- as long as they don't have heart problems.Griffin, an epidemiologist at Vanderbilt University, noted that the study reporting the link looked at people using as much as four times the recommended dose. She said the safety trouble may be caused by high doses. Griffin said it's best for people with heart disease to avoid Celebrex and other COX-2 inhibitors. New York cardiologist Dr. Richard Hayes said he would recommend his patients switch from Celebrex to over-the-counter medicines such as Advil to treat their pain. The National Cancer Institute was conducting the study in question for Pfizer. It halted the trial after finding that patients taking 400 to 800 milligrams of the drug daily were 2.5 times more likely to have major heart problems."These clinical trial results are new. The cardiovascular findings in one of the studies are unexpected and not consistent with the reported findings in the second study," said Hank McKinnell, Pfizer chairman and chief executive officer. "Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world."Celebrex is approved for use in the United States for the treatment of arthritis and pain.Dr. Joseph Feczko, president of worldwide development for Pfizer, said patients using Celebrex should discuss appropriate treatment options with their doctors."Physicians should factor this new information, as well as ulcer risks and gastrointestinal bleeding seen with traditional NSAIDs, into their prescribing decision," Feczko said. Pfizer's stock has been sliding since the announcement.
Previous Stories:
- December 6, 2004: Study: Celebrex Appears To Be Safer Than Vioxx
- October 7, 2004: Vioxx May Not Be Only Drug With Heart Risk
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