UAB Researchers Warn Test Subjects To Quit Taking CelebrexDec 29, 2004 | AP
Researchers at the University of Alabama at Birmingham are telling hundreds of patients participating in a dozen clinical studies to quit taking Celebrex while authorities determine whether the arthritis medication is safe.
Dr. John T. Carpenter, a cancer researcher, said officials are trying to get everybody off the drug.
"You have to stop until the issue is sorted out," he said.
The crisis started Dec. 17 when Celebrex maker Pfizer Inc. announced it had found an increased risk of heart attacks among people taking large doses of the drug as part of a colorectal cancer prevention trial being conducted at 100 medical centers through the National Cancer Institute. The trial was suspended, but the company left the drug on the market.
The National Institutes of Health ordered researchers and institutional review boards to conduct safety evaluations of about 40 other studies involving Celebrex or similar drugs. The NIH said participants should be asked to sign new consent forms with updated information about risks and benefits of the research.
Carpenter said the NIH directive is having a "huge impact" at UAB, a major medical research center. Given safety questions, researchers are calling Celebrex study participants and telling them to stop taking their drugs until risks can be properly evaluated.
A spokesman said UAB has 12 ongoing studies involving Celebrex. The studies are being conducted at UAB in conjunction with several other medical centers, and most involve cancer prevention and arthritis pain relief.
Carpenter said several hundred study participants will likely be taken off Celebrex. A spokesman for UAB said there may be some exceptions in special cases.
Among other things, UAB is looking at whether Celebrex could help stop a recurrence of lung cancer or prevent breast cancer. Carpenter said there was a good chance that Celebrex could saves lives from cancer in the long run.
"What we have to sort out is, what's going to be the cost in terms of toxicity or risk?" he said.