Vioxx and Heart Attacks

Numerous studies have proven that the use of Vioxx significantly increases the risk of heart attacks. Merck & Co. consistently disputed the results of these studies until September 30, 2004, when results of its own study corroborated the findings of previous studies.

The FDA, concerned about reports from JAMA and other medical publications that linked Vioxx to heart attacks, conducted its own analysis into the reported problems with Vioxx. The agency predicted Vioxx was responsible for approximately 27,000 heart attacks between 1999 and 2003.

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FDA Predicts Vioxx Responsible for 27,000 Heart Attacks

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On November 3, 2004 the FDA released a memo attributing as many as 27,785 heart attacks to the prescription drug Vioxx. The FDA concluded that those heart attacks could have been prevented if patients taking Vioxx had instead taken Celebrex, a competing arthritis drug. Another FDA official testified before Congress that the number could be as high as 139,000.

Merck officials refused to comment on either the FDA study or the agency's conclusions that Vioxx might have contributed to thousands of heart attacks.

The FDA reportedly analyzed data of 1.4 million people within the Kaiser Permanente health system. The report concluded that Vioxx use resulted in more than 27,000 heart attacks and death between 1999 and 2003.

JAMA Reports Vioxx Increases Risk of Heart Attacks

Vioxx Settlement

In August 2001, JAMA published the results of a study developed to assess the risks of Vioxx. The randomized trial included two groups of patients -- one group was given Vioxx (rofecoxib) and the other was provided naproxen. The results of the study are startling -- Vioxx users were more than twice as likely to suffer heart attacks and other serious cardiovascular events compared to those taking naproxen.

Faced with this troubling data, Merck & Co. immediately went on the attack. They charged that Vioxx was not harmful to the heart, but rather that naproxen was beneficial. Medical researchers never had associated naproxen with improving the condition of the heart.

Merck fired off a number of press releases defending the drug, including one on May 22, 2001 titled, "Merck Reconfirms Favorable Cardiovascular Safety of Vioxx." The company also held numerous conferences intended to confirm the safety of Vioxx.

The manufacturer of Vioxx consistently attacked any study that reported an increase in heart problems as a result of Vioxx use. The company would argue that the study was flawed and suggested only randomized and controlled trials would be reliable.

In spite of this constant criticism, Merck & Co. did not conduct a study aimed at assessing the risk of heart attacks in Vioxx users. The New York Times reported that company officials decided in May 2000 against conducting a clinical study to assess the safety of Vioxx. The VIoxx recall occurred only after the incidences of heart attacks showed up in a study aimed at determining whether Vioxx could be used to fight colon cancer.

While Merck officials publicly criticized studies showing Vioxx was linked with elevated risk of heart attacks and strokes, the chief researcher privately lamented that the links "are clearly there" and it was "a shame." In spite of this private acknowledgement that the drug was dangerous, the company continued to market it aggressively and refused for years to recall it from the market. These actions by Merck unnecessarily put millions of people at risk.

November 9, 2007—Merck announced that is has offered $4.85 billion to settle 27,000 lawsuits filed by people claiming injuries after taking Vioxx.

Vioxx was removed from the market in September 2004 after several studies revealed that the drug was associated with a substantially greater risk of heart attacks and strokes.