QUICK FACTS ON BEXTRA:
- On April 7th, FDA CALLS FOR REMOVAL OF BEXTRA FROM MARKET.
- Bextra was prescribed to millions of Americans to treat the pain associated with arthritis, menstrual discomfort, and other ailments.
- Bextra has been shown to more than double a patient’s chance of a severe coronary event such as a heart attack, stroke or death in some instances.
- Bextra common risks include angina, heart attack, stroke, death, fatal skin reactions, and Stevens Johnson syndrome.
- The American Heart Association presented with a report indicating patients using Bextra while recovering from heart surgery were 2.19 times more likely to suffer a stroke or heart attack than those taking placebos.
- Pfizer first acknowledged risks associated with Bextra in October of 2004.
- Bextra is part of a class of pain medications known as Cox-2 inhibitors.
BEXTRA IS RECALLED!
On April 7th, the FDA asked the maker of Bextra, Pfizer, to remove the pain medication from shelves across the United States. Canada Health quickly followed suit and asked Pfizer to also remove Bextra from Canadian shelves. Pfizer has also suspended sales of Bextra in the European Union.
The FDA also asked Pfizer to include a boxed warning in the Celebrex label highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with its use.
Although Pfizer claimed that Bextra was chemically different than Vioxx and did not present the same heart-related risks, Dr. Garret FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania, presented data in November proving that patients taking Bextra have a 2.19 times greater risk of experiencing a severe coronary event such as a heart attack, stroke or death. According to Dr. FitzGerald, “The magnitude of the signal with Bextra is even higher than what we saw with Vioxx. This is a time bomb waiting to go off.”
BEXTRA® SIDE EFFECTS!
BEXTRA ® has shown increased risk of:
- Heart Attacks
- Blood Clots or Clotting
BEXTRA ® has been associated with other serious side effects, including a potentially fatal skin disease named Stevens Johnson Syndrome. Symptoms of this fatal disease include:
- Skin rash
- Lesions of gums, tongue, or lips
- Sores in the urinary tract
BEXTRA ® users suffering from any of the above symptoms should immediately contact a physician.
KEY DATES ON BEXTRA
On April 7, 2005 , the FDA asked Pfizer, Inc. to withdraw Bextra from the market.
On February 2005, Wellpoint Inc. released a study that found Bextra, Celebrex and Vioxx increase the risk of heart attack or stroke in users. According to the research, the risk of heart attack was 53 percent higher than normal for patients taking Bextra, 19 percent higher for those taking Celebrex and 23 percent higher for patients taking Vioxx. The study reportedly found no increase in cardiovascular events in patients taking traditional anti-inflammatory medications.
On January 2, 2005 , health care giant Kaiser Permanente, an HMO serving 2.6 million Californians, stopped prescribing Bextra to its patients.
On December 17, 2004 , Pfizer Inc. announced that a study of Celebrex, the other remaining Cox- 2 inhibitor, showed that patients taking the drug daily had an approximately 2.5 fold increase in their risk of experiencing a major cardiovascular event.
On December 9, 2004 , The Food and Drug Administration (FDA) announced that a “Black box ” warning needed to be placed on all packages and labels of Bextra.
In December 2004, the European Medicines Agency (EMEA) and its Scientific Committee for human medicines were made aware of new safety information on cardiovascular and serious skin adverse events in relation to the use of valdecoxib and parecoxib sodium.
On November 11, 2004 , University of Pennsylvania researchers told the American Heart Association that a recent clinical trial revealed that patients taking Bextra had more than twice the incidence of heart attack and stroke than nonusers.
In November 2004, researchers presented the results of a study involving Bextra to members of the American Heart Association that showed the COX-2 inhibitor may increase the incidence of heart attacks and strokes. The study, headed by doctors at the University of Pennsylvania, pooled data from over 5,000 patients taking part in dozens of trials. The incidence of heart attacks and strokes among Bextra users was more than double that of those taking a placebo.
On October 15, 2004 , said two small clinical trials showed heart bypass surgery patients taking Bextra, an anti-inflammatory in the same class as the recently withdrawn drug Vioxx, had a higher risk of stroke and heart attack.
On September 30, 2004 , Vioxx one of the other two Cox-2 inhibitors, was withdrawn from the market due to a study linking it to increased heart attacks and strokes.
On Oct-18-04, Pfizer admitted that two small clinical trials showed heart bypass surgery patients taking Bextra had a higher risk of stroke and heart attack.