Pfizer Chief Executive Hank McKinnell said Sunday doctors should be made aware of the health risks in prescribing Celebrex to their patients, but the company does not plan to recall its popular arthritis drug.
Pfizer Inc. on Friday said Celebrex more than doubled the risk of heart attack in a large cancer-prevention trial, a setback that comes just weeks after Merck & Co. recalled its similar Vioxx drug due to heart safety risks.
“We’re leaving Celebrex on the market because it is an appropriate option for many, many patients,” McKinnell said on ABC’s “This Week.” “Physicians do need to be fully advised of the risks, and particularly this new information.”
The Food and Drug Administration on Friday urged doctors to consider prescribing alternatives to Celebrex. The agency said it would have more announcements about Celebrex in the next few days.
Dr. David Graham, associate director for science in the FDA’s Office of Drug Safety, criticized the agency for failing to protect the public from dangerous drugs.
COX-2 drugs in question
“The FDA, I believe, is more concerned with getting drugs on to the market than it is in getting safe drugs on to the market,” Graham said on the same television program.
Merck recalled Vioxx on Sept. 30 after a study found that a long-term use of the drug doubled the risk of heart attack and stroke. Both Celebrex and Vioxx belong to a class of drugs known as COX-2 inhibitors. They work by selectively blocking a protein called COX-2 that has been linked to inflammation.
Pfizer said the Celebrex trial, sponsored by the National Cancer Institute, involved patients taking 400-milligram and 800-milligram daily doses of the drug to prevent tumors known as adenomas that grow from glandular tissue. High doses of the anti-inflammatory drug were being tested on the theory that inflammation is a cause of cancer.
Celebrex is one of Pfizer’s biggest products, with 2003 sales of $1.9 billion.
