Vioxx, or rofecoxib, the non-steroidal anti-inflammatory drug (NSAID) prescribed for the treatment of arthritis and other acute pain, has been withdrawn from the market by its manufacturer.
According to a news release from the company, the decision was based on recent data from a study that suggests long-term use of Vioxx 25-mg may increase the "...relative risk for confirmed cardiovascular events, such as heart attach and stroke..."*
The manufacturer advises patients taking Vioxx to consult with their physician to discuss discontinuing use of Vioxx and the possibility of alternative treatments. And if you or someone you know was prescribed Vioxx and experienced any of the following, we would like to help:
- Heart attack
- Stroke
- Other serious blood, kidney, or cardiovascular problem
What Is VIOXX?Vioxx was developed in 1999 by Merck Pharmaceuticals as one of the first of a new class of painkillers. Vioxx is a member of a class of drugs called COX-2 selective nonsteroidal anti-inflammatory drugs, or NSAIDs. These painkillers were developed to be more effective at stopping pain without irritating the stomach.
Vioxx works by blocking the COX-2 enzyme that is thought to contribute to inflammation. It specifically does NOT block the COX-1 enzyme, which protects the stomach lining from acids, making it easier to digest.
Why Is VIOXX dangerous?The reason Vioxx causes heart attacks and stokes isn't certain, but COX-2 inhibitors suppress a protein responsible for the health of blood vessels and could promote clotting as a result. The COX-1 enzyme encourages blood clotting while the COX-2 enzyme inhibits clotting. Drugs like Vioxx that block COX-2 enzymes and allow COX-1 enzymes may increase blood clotting, an excess of which can lead to coronary events like heart attacks and strokes.
However, long before Merck pulled Vioxx from the market, studies led researchers to question the cardiovascular safety of Vioxx and other COX-2 inhibitors such as Celebrex. A study published in the Medical Journal showed that Vioxx might also cause kidney damage.
In addition to kidney failure, researchers are concerned about increased risk of heart attacks and strokes. In February, the FDA's arthritis drug advisory committee analyzed COX-2 inhibitors' cardiovascular risks. Merck presented a study to support is contention that Vioxx is safer on the gastrointestinal tract than other NSAIDs. Although the study found that Vioxx reduced the incidence of ulcers and other gastrointestinal problems by about half that of the over-the-counter NSAID Aleve, the study showed that people taking Vioxx had four times the risk of a heart attack.
Why should Merck be held liable for injuries caused by Vioxx? The popular and heavily advertised arthritis drug Vioxx has been linked by researchers to an increase in the risk of blood clots, heart attacks and strokes. On August 25, 2004, a study financed by the FDA found that people taking the recommended dose of Vioxx were at three times the risk of heart attack and sudden death compared to persons taking other non-steroidal painkillers such as ibuprofen. The U.S. Food and Drug Administration released another study in November 2004 that said Vioxx may have contributed to an additional 27,785 heart attacks or deaths from 1999 to 2003.
On September 29, 2004, Merck and Co., Inc. announced that it was withdrawing its arthritis drug Vioxx worldwide following indications after a colon cancer study confirmed long-standing concerns that the drug raises the risk of heart attack and stroke. Merck's decision to withdraw Vioxx from the market came after the Data Safety Monitoring Board overseeing a long-term study of the drug recommended that the study be halted immediately because of a dramatic increased risk of serious cardiovascular events in the study participants.
The fact that Vioxx probably increased the risk of heart attacks and strokes was known for three years, but Merck downplayed it and did not undertake studies to settle the matter. The risk was confirmed only by chance in a clinical trial for another purpose.
In 2000, the VIGOR (Vioxx Gastrointestinal Outcomes Research) study was published. This study was designed to examine the effects of Vioxx on gastrointestinal side effects such as ulcers and bleeding. The study showed that patients taking Vioxx had a highly statistically significant five fold increase in heart attacks. 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 2001 Merck ordered no trial , did no tests on Vioxx's cardiovascular safety, and spent 100 million to promote the drug including that press release issued May 22 2001 entitled "Merck reconfirms favorable cardiovascular safety of vioxx" In 2001, the FDA sent to Merck Chief Executive Raymond Gilmartin a warning letter. In the eight-page letter, the FDA says Merck engaged "in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed" in a clinical trial comparing Vioxx to naproxen , a less-expensive painkiller . "Your promotional campaign discounts the fact" that in the trial , "patients on Vioxx were observed to have a four to five-fold increase" in heart attacks , compared with patients on naproxen , the letter said.
The FDA letter also criticized 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. Merck has maintained that the reason it didn't know earlier of a link between Vioxx and heart attacks is because naproxen is "heart protective." But the FDA's letter says, "You fail to disclose that your explanation is hypothetical, has not been demonstrated by substantial evidence, and that there is another reasonable explanation, that Vioxx may have pro-thrombotic properties," (the clinical term for causing blood clots that could lead to heart attacks . )
The letter said the press release titled "Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx " was "simply incomprehensible," given the rate of heart attacks and "serious cardiovascular events compared to naproxen ."
Emails unearthed by the Wall Street Journal confirm Merck executives knew about the cardiovascular risks as early as 2000.
A new analysis published online by the British journal The Lancet pooled results from 29 studies of Vioxx and found that people who took it had more than double the risk of heart attack than those given dummy pills or other painkillers.
Legal action against the drug's manufacturer, Merck, is going forward. Serious questions about when Merck was first aware that potentially dangerous side effects were associated with Vioxx, and whether it failed to timely inform public health authorities of these side effects are being investigated. Additionally, we will argue that Merck's heavy marketing campaign may have resulted in over prescription of the drug and led many people to use it without understanding its dangers.
