What Is Bextra?
Bextra (Valdecoxib) was brought to the market in late 2001 by Pfizer as one of a new class of painkillers. Bextra is a member of a class of drugs called COX-2 selective nonsteroidal anti-inflammatory drugs, or NSAIDs.  These painkillers were developed to be more effective at stopping pain while being gentler on the stomach than existing painkillers such as Aleve.  However, new evidence has come to light that suggests the dangers posed by COX-2 inhibitors may far outweigh any benefits. Drugs like Bextra that block COX-2 enzymes and allow COX-1 enzymes are now thought to increase blood clotting, an excess of which can lead to coronary events like heart attacks and strokes.

Bextra Recall Information
On April 7, 2005, the FDA and European regulators formally asked Pfizer to suspend sales of Bextra in the United States and Europe. As a result, Pfizer announced it would halt sales of the drug in the United States and the European Union countries immediately. The FDA stated that the risks posed by Bextra outweigh its benefits. These risks include a high rate of heart attacks, strokes and Stevens Johnson Syndrome.

On January 17, the journal Circulation published a report on its website with evidence linking ALL COX-2 inhibitors with increased risk of heart attack and stroke, according to the Washington Post.  The study was lead by Dr. Garret FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania who has taken a leading role in demonstrating the risks of COX-2 inhibitor Bextra.  He and his research team gave mice a COX-2 inhibitor similar to Celebrex and, according to Kaisernetwork.org, "observed 'dangerously unstable' deposits of plaque, which makes artery walls more likely to repture and activate clotting and could lead to a heart attack or stroke in humans".  Dr. Fitzgerald noted that "the earliest evidence of cardiovascular risks associated with COX-2 drugs also came from animal experiments."

Although Bextra's manufacturer Pfizer claimed that Bextra was chemically different than COX-2 inhibitor Vioxx and did not present the same heart-related risks, Dr. FitzGerald presented data in November 2004 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.

The prescription painkiller Bextra (Valdecoxib) has now 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.  This represents a potential risk factor even greater than the painkiller Vioxx, which was removed from the market in September 2004.

Pfizer has also recently warned doctors that Bextra can cause rare but serious skin reactions like Stevens Johnson Syndrome more often than any other drug in its class. These potentially deadly skin reactions occur most often in the first two weeks of Bextra treatment.

The Sanders firm represents individuals and the families of individuals across America who have suffered severe injuries after use of the Bextra. Please contact us if you or a loved one has or you suspect that they have experienced these side effects from the use of Bextra or any other type of COX-2 drugs.

 If you need to contact us about this matter, please click here for a free online consultation. 

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Celebrex Is A Big Risk At High Doses
High-dose Celebrex triples heart risk

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• March 31, 2008 |

Patients taking the largest dose of 400 mg twice a day tripled their chance of a heart attack or stroke, compared with people taking a placebo, according to a study presented today at the American College of Cardiology meeting. The study confirms earlier concerns that prompted the FDA three years ago to warn that Celebrex and other painkillers, including ibuprofen and naproxen, should be prescribed at the lowest dose possible, Bloomberg News writes.

“There is clearly an increased risk with increased dose and because this tends to be with the higher doses it probably provides some level of comfort at the lower end of the Celebrex spectrum,” Scott Solomon, director of noninvasive cardiology at Brigham and Women’s Hospital in Boston and the author of the study, tells Bloomberg.

This is the abstract, this is the analysis, and this is Solomon’s presentation.

Patients taking 200 mg twice a day doubled their risk of a heart attack, but there was no increase in patients taking 400 mg once a day. That could be a result of chance because the number of patients studied was relatively small, Solomon tells Bloomberg. There was also an increased risk in people with heart disease, high cholesterol, diabetes or who smoked. Most arthritis patients are believed to take a total of 200 mg or less of Celebrex a day, according to Pfizer. The study didn’t examine risk for those lower doses, he adds.

Pfizer later removed Bextra and kept Celebrex should remain on the market, arguing there was no data showing a risk at the most commonly prescribed doses. The issue is being fought in court. A federal judge ruled last November that plaintiffs didn’t present scientifically reliable evidence that Celebrex caused heart attacks or strokes when taken at a daily dose of 200 mg. There are more than 3,000 lawsuits, but the ruling by US Districrt Court Judge Charles Breyer in San Francisco kept alive lawsuits involving the 400 mg dose.