Back grey_arrow_rt.gif
Pfizer says it sees no safety concerns in Celebrex studies
  NEW YORK (Reuters) - Pfizer Inc. said on Friday that three long-term studies seeking additional uses for its popular arthritis drug Celebrex (celecoxib) have turned up no cardiovascular safety concerns and that it plans to continue those trials to their conclusion.
Pfizer released the information a day after Merck & Co. pulled its rival COX-2 inhibitor Vioxx (rofecoxib) from the market when a study found long-term use of the medicine doubled the risk of heart attack and stroke. The news raised concern about the entire class of COX-2 inhibitors.
"In light of recent events we really want to reassure doctors who we work with and patients who take our product that we don't really have a cardiovascular concern," said Dr. Mitch Gandelman, Pfizer's vice president for worldwide medical, oncology and pain information.
The Merck study that led to the Vioxx withdrawal was designed to see if the drug could prevent recurrence of colon polyps. Increased heart risk began to appear after 18 months of use and was double in patients taking Vioxx for 3 years.
Pfizer said two of its ongoing Celebrex studies were for the same indication, while a third was testing the drug for use against Alzheimer's disease. The three studies, which are testing Celebrex at various doses versus a placebo, involve more than 6,000 patients, Pfizer said.
In one of the colon polyp trials, more than 900 patients had been taking Celebrex for 3 years with no evidence of increased cardiovascular risks, Gandelman said. In the other, 325 patients had reached the 3-year mark without turning up significant safety concerns.
The studies are expected to follow those patients for five years.
"Each COX-2 inhibitor has a distinct chemical structure and we would not expect them to have the same side-effect profile," Joe Feczko, Pfizer's president of worldwide development, said in a statement issued by the New York drugmaker.


Copyright © 2004 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
  icon paper stack View Older Articles   Back to Top