Vioxx's Hidden Risks

"During the past 25 years, 1 in 5 medicines were found to have serious side effects that were not recognized at the time of marketing" - Journal of the American Medical Association

Vioxx was removed from the market in September of 2004 by Merck because of the results of a clinical trial. 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. Those who have taken Vioxx and have suffered a severe coronary event, (or families of someone who died because of this) may have legal options to recover for damages.

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". A greater number is a bit of an understatement. According to the Public Citizen advocacy group:

"There was a highly statistically significant five-fold increase in heart attacks in the overall [Vioxx] group (0.5 percent) compared to the naproxen group (0.1 percent). This amounted to 20 heart attacks with [Vioxx] (out of 4,047 patients) compared with four with naproxen (out of 4,029 patients). This increased number of heart attacks was also accompanied by an increase in other thrombotic (blood clotting) adverse effects such as strokes and blood clots in the legs as well as problems with hypertension in the [Vioxx] group compared with the naproxen group."

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". On September 17, 2001, an FDA director sent a warning letter to Merck Chief Executive Raymond stating:

"You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on Vioxx were observed to have a four to five fold increase in myocardial infarctions [heart attacks] compared to patients on the comparator nonsteroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen)."

The Wall Street Journal states that FDA also "chastised Merck for suggesting to physicians that the reason patients taking Vioxx had a higher incidence of heart attacks in the study was that naproxen has heart benefits". The warning letter can be found on the FDA's website.
The FDA went on to call Merck's press release ("Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx") "simply incomprehensible" in light of the "serious cardiovascular events".

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.
  

If you or a loved one have taken Vioxx and have experienced any side effects, including blood clots, heart attacks, strokes or even sudden death, contact us immediately at 800-966-4999 or click here to send an e-mail inquiry and see why our law firm has recovered over 100 million dollars on behalf of our clients.