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Researchers at The University of Alabama at Birmingham (UAB) are telling hundreds of patients participating in a dozen clinical studies to quit taking Celebrex® while authorities determine whether the drug 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 December 17 when Pfizer, maker of Celebrex® announced it had found 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 has been suspended, but the drug is still on the market.
The National Institutes of Health (NIH) ordered researchers and institutional review boards to conduct safety evaluations of about 40 other studies involving Celebrex® or similar drugs. The NIH feels that participants should be asked to sign new consent forms with updated information about the risks of taking Celebrex®.
The NIH is having a large impact on studies at UAB persuading researchers to call Celebrex® study participants telling them to stop taking their drugs until the risks can be properly evaluated.
A spokesman at UAB said they have 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®.
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