Vioxx Information Center
Vioxx may increase a patient’s risk of heart attack, stroke and kidney failure according to studies that have appeared in Medical Journals.
A class of drugs called COX-2 inhibitors was developed in the late 1990's. COX-2 inhibitors were generally promoted as being safer and better pain treatment than the traditional and widely used nonsteroidal anti-inflammatory drugs, known as NSAID’s. NSAID’s include aspirin and ibuprofen.
However, studies have led some researchers to questions the cardiovascular safety of Vioxx and other COX-2 inhibitors such as Bextra and Celebrex. Another study published in the Medical Journal, The Lancet, indicated that this group of drugs may harm the kidneys. In the article, two Spanish doctors describe the case of a 67-year-old woman who developed kidney failure. Her kidney failure ended after she stopped taking Vioxx, leading the doctors to conclude that the kidney problems she experienced were related to the ingestion of the drug. This was the first case to show that COX-2 inhibitors may be associated with kidney problems.
Heart Attack Risks
Researchers are greatly concerned about the increased risk of heart attacks. The FDA's arthritis drugs advisory committee analyzed COX-2 inhibitors cardiovascular risks. Merck presented a study to support its 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 than that of the over-the-counter NSAID Aleve, the study showed that people taking Vioxx had four times the risk of a heart attack.
However, Merck claims their Vioxx studies show no evidence that the drug increases the risk of a heart attack compared with other NSAIDs. The company claims that Vioxx has little effect on the heart. They claim that the study appeared to increase the risk of a heart attack because Aleve, the drug in the study, like aspirin, actually reduces heart attack relative to people on Vioxx.
The FDA is considering changing the label of Vioxx to highlight the potential for heart problems.
An FDA panel concluded Vioxx should retain its strong warning that it can cause ulcers like the older, less expensive painkillers - The panel also concluded that doctors and patients should be warned that it might carry a heart attack risk. The panel said patients and doctors must be warned that in the study, Vioxx patients had more than twice the risk of heart attacks or other cardiovascular side effects as traditional pain killers users.
FDA's advisers concluded that more research is needed but that Vioxx's label should warn of the concern and potential danger. Although the FDA isn't bound by its advisers' recommendations it usually follows them.
VIOXX: Frequently Asked Questions
Q: Do Vioxx users have a right to be compensated for health problems caused by Vioxx?
A: If you believe Vioxx has caused you or a loved one significant harm, such as a stroke or heart attack, you may be entitled to a large compensatory award. You must protect those legal rights before they lapse by passage of time and are barred by various states' statutes of limitations. You should contact our firm immediately for a free evaluation of your claim.
From a legal perspective, there is strong evidence that Merck did not give full disclosure when discussing the risks associated with Vioxx. Merck has acted irresponsibly with regard to informing patients of the health risks associated with its drug. Through the help of our experienced attorneys, you may be able to acquire financial compensation for your injuries and treatment.
Q: Was Vioxx Recalled?
A: Yes, the drug maker "voluntarily", withdrew Vioxx from the market in September 2004 after a major study showed what many other studies did- namely that Vioxx dramatically increases patients risks for Heart Attack and Stroke. You should speak to your doctor about alternatives.
Q: What is Vioxx?
A: Vioxx is one of a class of drugs called COX-2 inhibitors used to relieve acute pain in adult patients. It treats the signs and symptoms of osteoarthritis. It is also used to treat painful menstrual cycles.
Vioxx is one of the fastest-selling new drugs in the world made by Merck & Co. The drug was approved by the FDA for the treatment of acute pain and osteoarthritis, the most common form of arthritis, caused by normal wear and tear of joints and afflicting 21 million Americans.
Special Warnings with Vioxx:
Serious problems from stomach ulcers, such as bleeding, are well-known complications in people treated with NSAIDs. Similar problems have occurred in people treated with Vioxx, although very rarely. The likelihood of stomach problems increases the longer you take drugs like Vioxx. However, even short-term treatment is not without risk. These problems can happen without any warning, but in some people may cause symptoms such as gnawing or burning stomach pain, black or tarry stools, or vomiting. If this happens, stop taking Vioxx and call your health care provider right away.
Check with your health care provider. Vioxx may not be right for you, if you have had ulcers or stomach bleeding, have had asthma, hives, or allergic-type reactions after taking aspirin or other NSAIDs, have severe kidney problems, have severe liver problems, are pregnant.
Q: What are some possible side effects of Vioxx?
A: Minor side effects can include: Upper respiratory tract infection, diarrhea, nausea, heartburn, swelling of the lower legs or fee and high blood pressure. Additionally, Rare reports of serious ulcers occurring in patients taking Vioxx.
As indicated above, new research indicates that Vioxx may carry an increased risk of heart attack. When compared to patients who took traditional pain killers, patients taking Vioxx were as many as four times as likely to suffer from a heart attack. Another study found that the drug may cause kidney failure.