Manufacturer: Merck & Co.
Date approved: 1999
Status: Voluntarily withdrawn
Approved uses: Treatment of pain associated with osteoarthritis
Off-Label uses: Pain relief, migraine headache relief, treatment of painful menstrual symptoms
• Blood Clots
• Heart Attack
• Sudden Death
Vioxx Recall Information
Vioxx is a Cox-2 inhibitor, manufactured by Merck & Co. Vioxx was used to treat osteoarthritis, severe menstrual cramps and acute pain before being withdrawn from the market. Vioxx was linked to an increased risk of blood clots, heart attack, stroke and sudden death in a 2001 study. Long-term patients, especially those who used Vioxx for more than 18 months, were found to be at a greater risk of developing severe Vioxx side effects.
Merck Admits Errors with Vioxx Reports
In September 2004, Merck announced the withdrawal of Vioxx from all worldwide markets after a long-term study was halted because of an increased risk of serious cardiovascular events including heart attack, stroke, blood clots and other cardiovascular complications among study patients taking the drug Vioxx. In September 2004, the Food and Drug Administration (FDA) acknowledged Merck�s voluntary withdrawal of Vioxx and issued a Public Health Advisory directed at patients who were prescribed Vioxx.
Some reports indicate that Merck was fully aware of Vioxx side effects and risks as early as March 2000 and that there was a concerted effort by the company to bury negative evidence and even distort the drug trials by excluding heart patients from the Vioxx studies. It has been claimed that the effort was done in an attempt to �mask� the rate of cardiovascular problems for Vioxx patients and that the pharmaceutical company put profit making before consumers’ health. Millions of Americans have taken the drug and the FDA estimates that more than 27,000 patients have suffered heart attacks or have died as a result of using Vioxx.
In May 2006, Merck publicly stated the company erred when it reported in 2005 that a crucial statistical test showed that Vioxx caused heart problems only after 18 months of use. The test does not support Merck’s former theory that only after 18 months of usage were there any serious heart risks for individuals who used Vioxx and that these risks were not apparent if patients took it for less than 18 months.
Scientists outside of Merck claim that Merck’s admission, when considered along with other clinical trials of the drug and studies tracking real-world Vioxx use, supports longstanding claims that Vioxx caused heart problems quickly. The 18-month issue is crucial for the 20 million Americans who took Vioxx. Merck currently faces at least 11,500 lawsuits, covering 23,000 people, from patients who say that Vioxx caused their heart attacks and strokes. Merck cited the 18-month theory when it withdrew Vioxx from the market.
In defending Vioxx lawsuits, Merck has consistently taken the position that Vioxx can cause heart problems only if it is used continuously for more than 18 months. However, in the five Vioxx court cases in which juries have reached decisions so far, Merck has lost three times. In two of the cases, the heart attack victim had taken the drug for fewer than 18 months.
Merck has based the 18-month theory largely on data from the Approve Study, in which the company tracked 2,600 patients in a test to see whether Vioxx could prevent colon polyps. In the Approve study, twice as many patients taking Vioxx suffered heart attacks or strokes as those taking a placebo. After the company submitted new data to the FDA as part of a one-year follow-up study of patients in the trial company, critics raised new questions about the Approve trial’s overall results. Some outside scientists have stated that the new data indicated that Vioxx’s dangers became evident after four months of use. Merck has disputed that interpretation and has stated that its newly discovered mistake was unrelated to that new data. Some reports indicate the company’s disclosed mistake is yet another example of Merck�s mishandling of the data to make Vioxx appear safer to the public.
An individual that believes they may have been harmed or suffered adverse heath effects from the usage of Vioxx should seek the advice of an attorney who specializes in pharmaceutical litigation.
Side Effects of Vioxx
Millions of people suffer from pain on a daily basis due to a variety of ailments and illnesses. National and international organizations and governments have recognized the need to help treat pain in an effective and non-harmful way.
Vioxx (rofecoxib) is a nonsteriodal anti-inflammatory drug (NSAID) formerly used to treat the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of severe menstrual symptoms in some women. It was also approved for the relief of the symptoms of rheumatoid arthritis in adults and children. Vioxx was a widely used prescription medicine produced by drug manufacturer, Merck and Co. and was available in both liquid and pill form.
The Food and Drug Administration (FDA) originally approved the use of Vioxx to treat pain in May 1999. Vioxx is included in the group of NSAIDs known as COX-2 inhibitors or Coxibs (CycloOxygenase-2 Inhibitors), which also includes the drugs Celebrex, and Bextra. Vioxx works by blocking the COX-2 enzymes that cause the inflammation and pain associated with the aforementioned conditions, particularly arthritis.
Vioxx is also closely related to nonselective NSAIDs, such as ibuprofen and naproxen. All NSAIDs inhibit COX-2, an enzyme linked to pain and inflammation, and the main difference between Vioxx and more traditional over the counter pain relievers is that Vioxx does not inhibit COX-1, which is thought to help keep the stomach lining intact. Therefore it was initially believed that Vioxx, and other drugs in its class, would be gentler on the stomach.
All prescription and over the counter medications come with a risk of side effects, some more serious than others. While NSAIDs are very effective at treating the painful symptoms of the aforementioned illnesses, the use of COX-2 drugs, including Vioxx, is associated in some patients with serious problems. These include, but are not limited to:
• Stomach ulcers (characterized by internal bleeding).
• Liver damage.
• Loss of appetite.
• Yellow coloring of skin or eyes.
• “Flu like” symptoms.
• Dark urine.
Perhaps most importantly, Vioxx and other drugs in its class have been closely linked with an increase in cardiovascular (CV) events, including:
• Heart attack.
• Blood clots.
In 2000, Merck and Co. completed a study known as the Vioxx Gastrointestinal Outcomes Research or “VIGOR” clinical trial. The trial conducted a prospective randomized double blind one-year study involving approximately 8,000 patients with arthritis. In this trial, approximately 4,000 patients took Vioxx 50mg a day and approximately 4,000 patients took a standard dose of Naproxen 1,000 mg a day.