Vioxx was a painkiller produced, marketed, and sold by Merck, which was withdrawn from the market in 2004 over safety concerns. Vioxx was designed to be used to treat various types of chronic pain, but especially arthritis pain. Merck marketed it heavily when it was first introduced and it proved to be popular until the major safety issues were revealed, including the risk of having a heart attack.
Merck voluntarily pulled Vioxx from shelves before the U.S. Food and Drug Administration (FDA) had a chance to require its discontinuation, but the company has since been accused of hiding information about side effects. Lawsuits, settlements to individuals, and criminal fines over the Vioxx scandal have cost the drug maker billions of dollars.
What is Vioxx?
Vioxx was a drug made by Merck, generic name rofecoxib that was used largely to treat arthritis pain, but also for certain types of premenstrual pain. Rofecoxib is a non-steroidal anti-inflammatory painkiller, or NSAID, similar to ibuprofen and naproxen sodium. Unlike those over-the-counter painkillers, rofecoxib is a COX-2 inhibitor. It treats pain and reduces inflammation by targeting the COX-2 enzyme, a crucial part of the inflammation pathway in the body.
The FDA approved rofecoxib in 1999 and Merck sold it under the brand names Vioxx, Ceoxx, and Ceeoxx. Millions of people received prescriptions for these drugs and many found relief from their pain. It was used in tablet form, in a suspension, and in an injectable form in hospital settings. It was only a few months after its release that the issues with Vioxx started to come to light.
Side Effects and Safety
Initially, Vioxx was marketed as being a relatively safe, yet potent painkiller. As an NSAID, its major side effect was gastrointestinal. Like other NSAIDs, Vioxx could cause stomach upset and bleeding. This did not warrant any serious precautions or warnings, but patients were expected to report any stomach discomfort so that dosage could be changed.
Clinical trials conducted by Merck had shown another side effect: an increased risk for an adverse cardiovascular event. Although the drug first came on the market in 1999, it wasn’t until 2002 that the FDA required that this risk be included on the label. In spite of this warning and the findings from trials, Merck continued to heavily market Vioxx as a safe painkiller.
Merck then conducted a study with Vioxx to find out if it could reduce the incidence of colon polyps in patients. The doctors conducting the study found that there were safety concerns related to heart attack and stroke. They found that for people taking Vioxx regularly for 18 months or more, there was a significant increase in the risk of having a heart attack or stroke.
That study did not show any increase in risk for patients taking the drug for less than 18 months, but another study from 2006, after the controversy with Vioxx was settled, found the drug could cause harm sooner. This study showed that one quarter of patients who suffered a heart attack while taking Vioxx did so in the first two weeks of using the medication.
Exactly why Vioxx can increase the risk of having a heart attack or stroke was hard to pinpoint, but it may be related to a substance called prostacyclin. Research has found that Vioxx suppresses prostacyclin, which is protective against heart attack and stroke. It relaxes blood vessels and minimizes the platelet formation that can lead to blood clots and subsequent heart attacks and strokes.
Withdrawal of Vioxx
It was this last study that finally persuaded Merck to give up its multi-billion dollar drug, into which it had poured so much marketing money and effort. Merck voluntarily withdrew Vioxx and other rofecoxib products from the marketplace. This was not forced by the FDA, which has still been reviewing the evidence against Vioxx in an attempt to make a decision. Because of the voluntary withdrawal, the FDA issued a warning against using the drug.
Although Merck made the withdrawal of Vioxx voluntarily, the situation raised a lot of questions about what the company knew, when they knew it, and how they handled that information. In 2004 the Senate Finance Committee hosted a hearing and heard several witnesses testify to the wrongdoing of the drug company in the case of Vioxx.
Witnesses said that Merck knew about the risks of heart attack or stroke for patients taking Vioxx and that they knew about those risks early on in the process of developing the drug. The company, as witnesses testified, also took steps to hide the information, to minimize it, and to design trials specifically to minimize the possibility that the risks would come to light.
The company was also accused of having a “too cozy” relationship with the FDA that contributed to the delay in warning the public. Merck spent two years in aggressively marketing Vioxx directly to consumers while it knew about the risks. One of the witnesses testifying was an FDA scientist who claimed that the organization repeatedly attempted to block his findings that Vioxx increased the risk of cardiovascular events.
Merck has paid the price for deceiving the public about Vioxx. The drug was a huge money maker for the company, but several thousands of people suffered because of it. Over 3,000 people who died of heart attack or stroke while taking Vioxx were represented in a class action suit that led to a settlement of $4.85 billion. Merck actually won several of the suits against it, but finally agreed to the settlement in 2007 to wrap up all individual and class action litigation relating to Vioxx. The company never admitted wrongdoing, and in fact denied all claims against it.
In addition to the individuals harmed by Vioxx, Merck was sued by several states. By 2011 the company had reached settlements with 43 states and the District of Columbia. The settlement included several hundred million dollars for states to resolve civil claims. Merck also paid a federal fine of over $320 million and pleaded guilty to a charge related to marketing Vioxx.