Vioxx, Celebrex & Bextra

Since Vioxx's removal from the market in September of 2004, an increasing amount of evidence has come to light linking ALL COX-2 inhibitors with increased risk for heart attacks, strokes and other severe coronary events.  Here is more information about the most dangerous COX-2 inhibitors; Vioxx, Celebrex and Bextra.

Vioxx
Vioxx was removed from the market in September 2004 after the results of a clinical trial were made public. The clinical trial, initially developed to determine whether Vioxx would be effective in preventing colon polyps, found that those taking the drug for longer than 18 months had double the risk of a heart attack or stroke as those taking a placebo. Those taking the highest daily recommended dosage were found to have three times the risk of a severe coronary event.

Although Merck has attempted to appear as a "good corporate citizen" by voluntarily removing Vioxx from the market, there is evidence that Merck allegedly knew about the potentially deadly side effects of Vioxx since at least 2001.

In 2000, the VIGOR (Vioxx Gastrointestinal Outcomes Research) study was published. The study was originally designed to examine the effects of Vioxx on gastrointestinal side effects such as stomach ulcers and bleeding. According to the FDA, the study "showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking naproxen (Aleve), however, the study also showed a greater number of heart attacks in patients taking Vioxx".

Yet Merck made no mention whatsoever of this deadly danger in its advertising for Vioxx. Merck even went so far as to release a press release entitled "Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx".

In February 2005, three more pieces of information came to light about Merck's knowledge of Vioxx's deadly side effects:

"According to the Wall Street Journal, the committee monitoring the safety reports from the colon polyps trial, the trial that eventually led to Vioxx's removal from the market, found that cardiac problems associated with the painkiller could occur in as few as FOUR months. To date, Merck has only acknowledged that Vioxx can cause severe cardiac problems after 18 months. Had Merck released this information to the public, some Vioxx users may have had up to a year's additional warning.

The New York Times has evidence that, although Merck "executives have long insisted that they never pursued a clinical trial to directly study the heart risks" of Vioxx, Merck was in fact "poised to begin a major cardiovascular study of the drug in 2002." Merck cancelled the study less than a week before it was set to begin. The study "may have provided answers about Vioxx's risks even earlier" than 2004, which Merck acknowledged Vioxx's deadly side effects.

The Chicago Tribune has reported that Merck actually did submit a study to the FDA indicating that older patients taking Vioxx might be at a higher risk for developing cardiovascular problems...in 2002. The study was not flagged by the FDA for further review. Dr. Guirkipal Singh of Stanford University commented that, "You would think physicians would want to know Merck had evidence indicating that patients taking Vioxx in two clinical studies were twice as likely to die as those taking placebos. It's a very important finding." The FDA's Dr. Curt Furberg went on to say:  "[the] studies show a substantial increase in mortality associated with Vioxx. This should have been a very strong signal to Merck that they had real problems with this drug."
 
Celebrex
Ironically, Celebrex dangers were demonstrated during a study conducted by the National Cancer Institute and paid for by Pfizer itself. In the study, called the Adenoma Prevention with Celecoxib (APC) trial, patients taking 800 milligrams a day of Celebrex had 3.4 times the risk of a severe coronary event as those given a placebo, while those taking 400 milligrams had 2.5 times the risk. The trial was halted after the risk factor was demonstrated.

However, new evidence has emerged that may prove that Pfizer knew about Celebrex's risks... years earlier than the December 2004 revelations. After Vioxx was recalled from the market in late 2004, Pfizer released a statement that said, "The evidence distinguishing the cardiovascular safety of Celebrex has accumulated over years in multiple completed studies, none of which has shown any increased cardiovascular risk for Celebrex."

In February 2005, Pfizer acknowledged the existence of a 1999 study, designed to examine whether Celebrex could treat Alzheimer's disease, that found "the number of Celebrex patients suffering heart attacks was almost four times (3.6 times) that of those taking a placebo... In fact, the study found that 22 out of 285 patients taking Celebrex suffered heart attacks, strokes and other heart problems. Only 3 out of 140 patients taking a placebo had similar problems....Pfizer's own analysis found the difference statistically significant." (The New York Times). The study was never published and was not submitted to the FDA until several years later.

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 Celebrex's dangers. As a December 18, 2004 New York Times editorial states:  "...if Vioxx was risky enough for Merck to remove from the market, one wonders why Celebrex should not be yanked as well." 

Bextra
Although Bextra's manufacturer Pfizer claimed that Bextra was chemically different than the COX-2 inhibitor Vioxx, and did not present the same heart-related risks, these claims would soon be proven false. At the American Heart Association's annual conference on November 9, 2004 Dr. Garret FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania, 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 now different than Vioxx, and Pfizer is trying to suppress that information."

In the wake of Vioxx's removal from the marketplace in September 2004, Bextra came under increased scrutiny. Pfizer issued a warning to doctors on October 15, 2004, stating that not only did Bextra cause severe skin-related side effects such as Stevens Johnson Syndrome, but it did so more often than any other COX-2 inhibitor. In addition, Pfizer warned that the risk of developing these conditions was greatest within the first two weeks of using Bextra.

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 the label for the prescription painkiller Bextra (Valdecoxib) would be changed to include warnings on two potentially deadly side effects: the increased risk of a patient suffering a severe coronary event such as a stroke or heart attack, and the increased risk of a patient suffering a serious skin reaction, such as Stevens Johnson Syndrome. Many experts feel these new warnings do not go far enough to protect the public:

"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." - Dr. Garret FitzGerald

If you or a loved one have taken a COX-2 inhibitor like Vioxx, Celebrex or Bextra and have experienced any side effects, including blood clots, heart attacks, strokes or even sudden death, contact us immediately at 800-966-4999 and see why our law firm has recovered over $100 million on behalf of our clients.