Coronary Events

Drugs (like Bextra) that block COX-2 enzymes and allow COX-1 enzymes, called COX-2 inhibitors, may increase blood clotting, an excess of which can lead to coronary events like heart attacks and strokes. In the wake of Vioxx's removal from the marketplace in September of 2004, Bextra came under increased scrutiny. According to The New York Times, "since the Vioxx withdrawal, Pfizer has been emphatic in playing down concerns about higher risk for heart attack and stroke" in its two COX-2 inhibitors, Bextra and Celebrex.

However, Pfizer issued a warning on October 15, 2004 notifying doctors that a recently completed study, combined with the results of a study published in 2003, indicated Bextra might increase the risk of severe coronary events like heart attacks or strokes in patients recovering from coronary artery bypass surgery. The tests were conducted with an intravenous drug called Percoxib, which is nearly identical to Bextra. WebMD states that the "study conducted by Pfizer included more than 1,500 patients treated after heart bypass surgery. The study showed increases in heart attacks, strokes and blood clots in the legs and lungs in patients treated with Bextra (about 1% of patients suffered one of these effects after taking Bextra) compared with 0.5% of patients taking a placebo."

At the time, Dr. Garret FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania, criticized Pfizer in The New York Times for not making this latest information available more quickly since Pfizer had actually completed the study in the spring of 2004. Pfizer again repeated its claims that Vioxx and Bextra were chemically different and did not pose similar heart-related risks.

These claims would soon be proven false. At the American Heart Association's annual conference on November 9 2004, Dr. FitzGerald presented the results of a study that indicated patients who took Bextra experienced severe coronary events like heart attacks and strokes 2.19 times as often as those who took a placebo. According to the Kaiser Network, the study examined data from 5,930 participants in 12 clinical trials that involved Bextra. Curt Furberg, a Wake Forest University School of Medicine professor, stated that "basically, we showed that Bextra is not different than Vioxx, and Pfizer is trying to suppress that information."

On November 17 2004, David Graham, the associate director of the FDA's Office of Drug Safety, testified before a Senate hearing that Bextra was one of the five most dangerous drugs on the market and carried cardiovascular risks similar to those linked to Vioxx.

On December 9 2004, the FDA announced that Bextra's warning label would be changed to warn patients about its potential heart and blood-clotting risks. Senate Finance Committee Chair Chuck Grassley noted that the FDA stopped short of a recall and stated "when the FDA approves the drug, you should be able to bank on it. If a drug isn't safe, you should know the FDA will take it off the market." Sidney Wolfe, director of advocacy group Public Citizen's Health Research Group, said that the FDA "once again [sided] with a large pharmaceutical company, in this case Pfizer, in refusing to ban Bextra".

Other organizations are not waiting for a recall. USA Today reported that the Annals of Internal Medicine urged doctors not to prescribe COX-2 inhibitors to patients at risk of developing heart disease. British regulators have advised physicians to switch patients with heart disease to different drugs "as soon as is convenient". And in late January 2005, Kaiser Permanente, the nation's largest not-for-profit HMO, ordered its pharmacies to stop dispensing Bextra because of the related heart risks.

The latest move comes from the FDA, which issued a warning on Janurary 9, 2005 to Pfizer "that television and print advertisements for its painkillers Celebrex and Bextra misled consumers. The report found that five advertisements did not disclose side effects and other risk information and made "unsubstantiated effectiveness claims" (The New York Times). Pfizer had no comment on the Bextra material.

Although Bextra is now thought to cause dangers similar to Vioxx and Celebrex, Pfizer has not recalled Bextra from the market. Those who have taken Bextra and suffered skin reactions like Stevens Johnson Syndrome or severe coronary events such as strokes or heart attacks, or their families if the coronary event resulted in death, may have legal options to recover for damages.

It now appears that the side effects caused by the entire class of drugs to which Bextra, Celebrex and Vioxx belong, COX-2 inhibitors, may be far worse than any potential benefit. In fact, no study ever showed that the COX-2 inhibitors offer significantly better relief than the traditional NSAID family of drugs that includes aspirin, ibuprofen, and naproxen.
With the FDA's recent actions on Vioxx, many experts believe it is only a matter of time before more serious efforts are taken to protect patients from Bextra's dangers. As the FDA's own David Graham stated in late December:

"The FDA is saying they can't be sure these drugs are safe. Well, if they're concerned, perhaps people shouldn't be using [the drugs] at all."

If you or a loved one have taken Bextra and have experienced any side effects, including blood clots, heart attacks, strokes, sudden death or severe skin reactions, contact us immediately at 800-966-4999 and see why our law firm has recovered over $100 million on behalf of our clients.

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