PSA Rising, December 17, 2004. The Food and Drug Administration (FDA) learned last night from the National Cancer Institute (NCI) and Pfizer, Inc., that NCI has stopped drug administration in an ongoing clinical trial investigating a new use of Celebrex (celecoxib) to prevent colon polyps because of an increased risk of cardiovascular (CV) events in patients taking Celebrex versus those taking a placebo.
Patients in the clinical trial taking 400 mg. of Celebrex twice daily had a 3.4 times greater risk of serious cardiovascular event (fatal or non-fatal) compared to placebo. For patients in the trial taking 200 mg. of Celebrex twice daily, the risk was 2.5 times greater. The average duration of treatment in the trial was 33 months.
A similar ongoing study comparing Celebrex 400 mg. once a day versus placebo, in patients followed for a similar period of time, has not shown increased risk.
Compared with NCI's decision to halt the trial, the FDA's reaction is sluggish.
"Although these are important findings," the agency states in a press release, "at this point FDA has seen only the preliminary results of the studies. FDA will obtain all available data on these and other ongoing Celebrex trials as soon as possible and will determine the appropriate regulatory action. "
"While we have not seen all available data on Celebrex," the press release goes on, "these findings are similar to recent results from a study of Vioxx (rofecoxib), another drug in the same class as Celebrex. Vioxx was recently voluntarily withdrawn by Merck. Another drug in this class, Bextra (valdecoxib) has shown an increased risk for CV events in patients after heart surgery. Bextra and Celebrex are the only two selective COX-2 agents currently on the U.S. market."
FDA says "physicians should consider this evolving information in evaluating the risks and benefits of Celebrex in individual patients. FDA advises evaluating alternative therapy. At this time, if physicians determine that continued use is appropriate for individual patients, FDA advises the use of the lowest effective dose of Celebrex."
Patients who are currently taking Celebrex and have questions or concerns about the drug should discuss them with their physicians.
Doctors writing in The New England Journal of Medicine today recommended physicians to stop prescribing Pfizer Inc.'s Bextra painkiller.
In a letter, three top doctors said that in light of Vioxx and negative signs on Bextra, Bextra should be avoided.
"We believe the doubts raised about the safety of valdecoxib (Bextra), constitute a potential imminent hazard to public health" and thus they should be prescribed only in "extraordinary circumstances," editorial writers at The New England Journal of Medicine wrote in an issue dated Dec. 23, but released early.
Dr. Richard Hayes, a cardiologist at New York University, told Reuters today, "This raises my concern about Celebrex and all the COX-2 inhibitors, so I will no longer be prescribing any of them."
Pfizer is not talking about puling Celebrex from the market. Last month Merck withdrew its COX-2 inhibitor arthritis drug Vioxx after data showed increased risk of heart attack and stroke. In contrast, Pfizer executives today continued to tout Celebrex's value for arthritis patients.
"Celebrex is an important medicine that provides necessary pain relief to many patients," president of worldwide development Dr. Joseph Feczko said. "Patients being treated with Celebrex should discuss appropriate treatment options with their healthcare professionals. Physicians should factor this new information, as well as ulcer risks and gastrointestinal bleeding seen with traditional NSAIDs, into their prescribing decision."
Update by J. Strax, December 17, 2004
