The first Celebrex trial, originally set for June 6, 2006, has been delayed indefinitely, reportedly to give attorneys more time to gather information. Although no new trial date has been set, legal analysts now predict that Celebrex trials will begin in early 2007.
The delay was requested by a federal judge in San Francisco, where Pfizer is facing around 1,500 lawsuits related to its painkillers Celebrex and Bextra, according to Bloomberg News. In light of the studies on Celebrex that have surfaced over the past year, any media update should say 1,500 lawsuits and counting.
The lawsuits filed actually list defendants involved in the development, manufacturing and distributing of Celebrex as Pfizer Inc, Pharmacia Corp, Monsanto Co, and GD Searle & Co.
On August 30, 2006, Health Day News doused Pfizer's last hope of ever finding a reason to justify the over-prescribing of Celebrex when it reported that the "final word on whether the cox-2 painkiller Celebrex might be used to prevent colon cancer is a definite "no," according to the long-awaited results of two major studies."
"Both of the three-year trials found that the drug reduced the occurrence of precancerous polyps called adenomas in people at risk for colon cancer," Health Day wrote, "but it more than doubled patients' risk for heart attack and other serious cardiovascular events."
"The message is that celecoxib has no role as a chemotherapeutic agent -- in people with adenomas or in people among the general population," said Dr Bruce Psaty, a professor of medicine, epidemiology and health services at the University of Washington in Seattle, who co-authored an editorial on the two studies, published in the August 31, 2006, New England Journal of Medicine.
According to Dr Psaty, the take home message is that the cardiovascular risks "far outweighed even the most optimistic projections about the drug's cancer-prevention properties."
More bad news was reported a week earlier on August 24, 2006, by MedPage Today, in the results of a Canadian study that found women who take NSAIDs (nonsteroidal anti-inflammatory drugs), such as Celebrex, during the first trimester of pregnancy have twice the risk of having babies with congenital anomalies, particularly cardiac septal defects, researchers reported.
Of 1,056 women who filled prescriptions for NSAIDS during the first trimester of pregnancy, 8.8% had infants with congenital abnormalities, compared with 7% of 35,331 women who did not use NSAIDs, said Anick Berard, PhD, of Sainte-Justine Hospital, and colleagues, in the September 2006, issue of Birth Defects Research Part B.
And a few months ago on March 1, 2006, the Scotsman reported: "In a study involving more than 4,000 patients, Celebrex, which is the most commonly used Cox-2 inhibitor, was found to increase the risk of heart attacks by 2.26 times."
The leader of the study, Professor Richard Beasley, from the Medical Research Institute of New Zealand, warned that, "Given the popularity of this in the treatment of arthritis, drug regulators must undertake an up-to-date risk assessment based on the findings presented here."
The study was published in the Journal of the Royal Society of Medicine and reported that in addition to the increased risk when compared to a placebo, the use of Celebrex also had a 1.88-fold increase in the risk of heart attacks when compared with other painkillers.
According to a November 16, 2005, study conducted in Denmark, presented to the American Heart Association, people who have survived a previous heart attack and take Celebrex are at an increased risk of death, especially if they take Celebrex at higher doses.
The lead researcher, Dr Gunnar Gislason, stated that people with heart disease or history of heart attack should not use Celebrex. The study showed that heart disease patients who take 200 mg of Celebrex a day are more than four times more likely to die.
The first Celebrex trial that was delayed involves the case of Rosie Ware, an Alabama woman who alleges that a stroke at age 53, in February 2005, was caused by Celebrex and that the stroke has resulted in medical, hospital, and after-care costs of "substantial sums of money."
Ms Ware is represented by the law firm of Beasley, Allen, Crow, Methvin, Portis & Miles, in Montgomery, AL. On February 28, 2006, Attorney Jere Beasley told the Wall Street Journal that his client, a nonsmoker whose health was "very good" before her stroke, took Celebrex for back pain and was left disabled and unable to work after the stroke.
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