In addition, under "General Precautions" it warns: "Bextra and other NSAID medications can cause serious problems such as liver damage. Some of the warning signs of liver damage are nausea, vomiting, tiredness, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine."
The FDA warned: "Bextra can cause fluid retention (holding of water in your body). Fluid retention can be a serious problem if you have high blood pressure or heart failure."
But none of this information is actually "new" news. Back on October 16, 2004, Dr Sandra Kweder, the FDA's then acting director of the office of new drugs, told the New York Times that Bextra had not been proved to be any better than older medicines at guarding against stomach bleeding and had not been proved to be any better at relieving pain than older drugs.
A little over a month later, on November 18, 2004, Dr David Graham, associate director of drug safety in the FDA, testified at a Congressional hearing on Vioxx and said, "I can tell you right now, there are at least five drugs on the market today that I think need to be looked at quite seriously to see whether or not they belong there."
When asked which drugs he was referring to, Dr Graham identified Accutane, Bextra, Crestor, Meridia and Serevent. He was later accused of providing "inflammatory" testimony.
Since he testified, its worth mentioning that the FDA has either taken regulatory action, or has current action pending, on 4 out of the five drugs identified by Dr Graham.
And come to find out, on November 15, 2004, 3 days before Dr Graham gave "inflammatory" testimony, physicians were warned at the annual conference of the American Heart Association that Bextra might increase the risk of heart attack or stroke in patients who have had coronary artery bypass surgery (CABG), based on the results of a study conducted at the University of Pennsylvania.
Dr Garret Fitzgeral, a cardiologist and pharmacologist at the University, presented the results at the conference and described Bextra as "a time bomb waiting to go off."
The Pennsylvania study examined 5,930 subjects in twelve clinical trials and found patients who took Bextra experienced heart attacks and strokes 2.19 time more often than patients who received a placebo.
Less than one month after Dr Graham testified, the FDA issued a public health advisory on Bextra and said a change would be made in the product label to provide consumers with upgraded information about risks associated with the drug.
On December 9, 2004, the agency announced new information on Bextra side effects, and referred to another study, this one conducted by Pfizer, which included over 1,500 patients treated with Bextra after CABG, that showed an increased cardiovascular risk in patients treated with treated with the drug over those who received a placebo.
"Observed cardiovascular events," the FDA advisory said, "included thromboembolic events such as myocardial infarction (heart attack), cerebrovascular accident (stroke), deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung)."
"Bextra is not approved for use in the treatment of postoperative pain of any type;" the FDA pointed out in an advisory, "however, FDA believes that these new findings should be made available to healthcare professionals and patients, and the bolded warning specifically contraindicates Bextra for treatment of pain immediately following CABG," it said.
The FDA ordered a new label containing a "bold-faced warning" against prescribing and using Bextra for patients who have had heart bypass surgery, according to USA Today on December 10, 2004.
According to the FDA, Pfizer submitted the report to the agency on November 5, 2004.
Yet, on October 16, 2004, the New York Times reported that Pfizer had warned doctors "yesterday" that one of its best-selling painkillers, Bextra, might increase the risk of heart attack or stroke in coronary artery bypass surgery patients, and the newspaper noted that the news came only 2 weeks after Vioxx was pulled off the market.
According to the Times, Pfizer said a study involving more than 1,500 patients showed that those who had undergone bypass surgery and had taken Bextra were at higher risk and that an initial study last year raised similar concerns in the same kinds of patients.
The FDA warned: "Bextra can cause fluid retention (holding of water in your body). Fluid retention can be a serious problem if you have high blood pressure or heart failure."
But none of this information is actually "new" news. Back on October 16, 2004, Dr Sandra Kweder, the FDA's then acting director of the office of new drugs, told the New York Times that Bextra had not been proved to be any better than older medicines at guarding against stomach bleeding and had not been proved to be any better at relieving pain than older drugs.
A little over a month later, on November 18, 2004, Dr David Graham, associate director of drug safety in the FDA, testified at a Congressional hearing on Vioxx and said, "I can tell you right now, there are at least five drugs on the market today that I think need to be looked at quite seriously to see whether or not they belong there."
Since he testified, its worth mentioning that the FDA has either taken regulatory action, or has current action pending, on 4 out of the five drugs identified by Dr Graham.
And come to find out, on November 15, 2004, 3 days before Dr Graham gave "inflammatory" testimony, physicians were warned at the annual conference of the American Heart Association that Bextra might increase the risk of heart attack or stroke in patients who have had coronary artery bypass surgery (CABG), based on the results of a study conducted at the University of Pennsylvania.
Dr Garret Fitzgeral, a cardiologist and pharmacologist at the University, presented the results at the conference and described Bextra as "a time bomb waiting to go off."
The Pennsylvania study examined 5,930 subjects in twelve clinical trials and found patients who took Bextra experienced heart attacks and strokes 2.19 time more often than patients who received a placebo.
Less than one month after Dr Graham testified, the FDA issued a public health advisory on Bextra and said a change would be made in the product label to provide consumers with upgraded information about risks associated with the drug.
On December 9, 2004, the agency announced new information on Bextra side effects, and referred to another study, this one conducted by Pfizer, which included over 1,500 patients treated with Bextra after CABG, that showed an increased cardiovascular risk in patients treated with treated with the drug over those who received a placebo.
"Observed cardiovascular events," the FDA advisory said, "included thromboembolic events such as myocardial infarction (heart attack), cerebrovascular accident (stroke), deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung)."
"Bextra is not approved for use in the treatment of postoperative pain of any type;" the FDA pointed out in an advisory, "however, FDA believes that these new findings should be made available to healthcare professionals and patients, and the bolded warning specifically contraindicates Bextra for treatment of pain immediately following CABG," it said.
The FDA ordered a new label containing a "bold-faced warning" against prescribing and using Bextra for patients who have had heart bypass surgery, according to USA Today on December 10, 2004.
According to the FDA, Pfizer submitted the report to the agency on November 5, 2004.
Yet, on October 16, 2004, the New York Times reported that Pfizer had warned doctors "yesterday" that one of its best-selling painkillers, Bextra, might increase the risk of heart attack or stroke in coronary artery bypass surgery patients, and the newspaper noted that the news came only 2 weeks after Vioxx was pulled off the market.
According to the Times, Pfizer said a study involving more than 1,500 patients showed that those who had undergone bypass surgery and had taken Bextra were at higher risk and that an initial study last year raised similar concerns in the same kinds of patients.
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