How Vioxx Became One of the Largest Drug Recalls of All Time

How Vioxx Became One of the Largest Drug Recalls of All Time

by / Friday, 02 December 2016 / Published in Defective Products

When the prescription drug Vioxx hit the market in May of 1999, it was touted as a new type of NSAID painkiller intended to help with osteoarthritis pain, as well as other types of chronic and acute pain. Vioxx was supposed to be different from other types of painkillers because it wouldn’t cause the types of gastrointestinal problems that were linked to older painkillers. Five years later, Vioxx became one of the most significant defective drug cases of all time after it was pulled from the market due to the fact it increased the risk of heart attacks and other cardiac problems.

After Merck, the manufacturer of Vioxx, requested approval for Vioxx from the FDA in November 1998, they launched a study to prove that Vioxx was indeed safer for the digestive system than other painkillers. This study, known as the Vioxx Gastrointestinal Outcomes Research Study (VIGOR), involved over 8,000 participants, half of whom took Vioxx while the other half took naproxen, an older type of painkiller. The drug had been tested prior to this study, but VIGOR was the largest Vioxx study at that point.

As of October 1999, results from the VIGOR study showed that the group taking Vioxx did have fewer ulcers and bleeding problems than the control group. But by the following month, 79 patients taking Vioxx had either died from a heart attack or suffered from other serious heart problems. In December 1999, the safety panel evaluating the VIGOR test results informed Merck that the risk of heart attacks and other cardiac problems was twice as high for patients taking Vioxx than for the group taking naproxen.

A little over a year after Vioxx became available to the public, information about the results of the VIGOR study were published in the New England Journal of Medicine, but Merck withheld information about some of the heart attacks and other types of heart problems that patients taking Vioxx had experienced during the study. The full results of the VIGOR study wouldn’t become available to the public until February 2001, when the FDA published the results on their website. Using that data, independent cardiologists were able to analyze the results and came to the conclusion that naproxen did nothing to prevent heart attacks, which is the theory Merck had been trying to use to explain why the rate was higher in the group taking Vioxx. Several subsequent studies followed linking Vioxx to an increased risk of cardiovascular problems.

Merck did not pull Vioxx from the market until September 2004 after another study they conducted also demonstrated a connection between Vioxx and heart attacks. By then, about 20-25 million people in the United States alone had taken Vioxx. One study published in the Lancet medical journal estimated that 88,000 Americans had suffered a heart attack while taking Vioxx and 38,000 of them died as a result.

The outcry over Vioxx was immediate. Thousands of patients and family members of those harmed or killed by Vioxx started filing lawsuits against Merck and many of their cases were filed as part of a multi-district lawsuit. Merck set up a fund to settle those cases, as well as a separate $4.85 billion fund to settle other lawsuits related to the drug. At the time, it was believed to be the largest settlement fund ever created for a defective drug settlement. In addition to the lawsuits filed by individuals who were directly harmed by the drug, Merck was criticized by the New England Journal of Medicine for withholding information from their published study of the VIGOR results. Merck also faced criminal charges due to questionable sales and marketing techniques and a questionable relationship with the FDA. Eventually, Merck pleaded guilty to federal misdemeanor charges related to how Vioxx was marketed and paid $950 million in fines.

 

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