Vioxx - FAQs
Q: What is Vioxx?
A: Vioxx is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). Vioxx is also related to the nonselective NSAIDs, such as ibuprofen and naproxen. Vioxx is a prescription medicine used to relieve signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles.
Q: What is the most important information I should know about Vioxx?
A: On September 30, 2004, Merck & Co., Inc., the manufacturer of Vioxx, announced a voluntary withdrawal of the arthritis and pain relief drug from the worldwide drug market, after results from a recent clinical trial indicated that Vioxx users may have an increased risk of suffering a heart attack, stroke, or other cardiovascular event. Merck's action was not ordered by the U.S. Food and Drug Administration (FDA), but was initiated by Merck based on its own findings from the clinical trial.
Q: Did the FDA take any action in connection with Vioxx's withdrawal from the market?
A: FDA issued a public health advisory concerning the use of Vioxx. This advisory is based on Merck & Co., Inc. voluntarily withdrawing Vioxx from the market due to safety concerns. You can read the FDA's Public Health Advisory on Vioxx here.
Q: Does Merck's action in withdrawing Vioxx suggest that other drugs in the same class are dangerous?
A: The results of clinical studies with one drug in a given class do not necessarily apply to other drugs in the same class. All of the NSAIDs have risks when taken chronically, especially of gastrointestinal (stomach) bleeding, but also liver and kidney toxicity. Patients using these drugs for a long period of time (longer than two weeks) should be under the care of a physician.
Q: What have been the most serious health concerns raised regarding Vioxx?
A: Vioxx has been linked to possible cardiovascular complications, including blood clots, heart attacks and strokes, and to kidney failure. Besides the known cardiovascular risks associated with Vioxx, which prompted Merck to pull the drug from the marketplace, other serious side effects can occur during treatment with this medicine. Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; blood in your vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of your skin or eyes; "flu-like" symptoms; or unusual bruising or bleeding.
Q: Can a pharmacist continue to fill my prescription for Vioxx?
A: No, Merck is initiating a market withdrawal in the United States to the pharmacy level. This means Vioxx will no longer be available at pharmacies.
Q: What other drugs are similar to Vioxx?
A: Vioxx is a COX-2 selective, nonsteroidal anti-inflammatory drug (NSAID). Other COX-2 selective NSAIDs on the market at this time include Celebrex* (celecoxib). Vioxx is also related to the nonselective NSAIDs, such as ibuprofen and naproxen. You should consult your physician to determine which treatment is right for you.
(*Note: in April 2005, FDA required that Celebrex packaging carry stricter warnings of heart attack and stroke risk associated with use of Celebrex.)
Q: What should I tell the doctor if I suspect I have arthritis?
A: The following include some of the things you should tell your doctor: where you have pain or stiffness; when you have pain or stiffness; what the pain feels like (sharp/stabbing, dull/aching); how long the pain lasts; how long you have had the pain; what tasks you find difficult to do now; if you ever injured your joints or overused them in a job or a hobby; if anyone in your family had problems similar to yours; if you exercise, what kind of exercise you do and how often you do it.
Q: What questions should I ask before leaving the doctor's office for treatment of arthritis?
A: What can I do to help relieve my pain and live more comfortably? What are the advantages and disadvantages of my various treatment options? When might I expect to start feeling better? What can I expect over the coming months/years? Under what circumstances should I call your office?
Q: What should I do if I think I have been injured as a result of taking Vioxx?
A: If you have experienced unusual side effects after taking Vioxx, you should consult your physician immediately. Thereafter, you might want to contact an attorney experienced in product liability litigation to discuss potential legal claims you might have to recover for injuries Vioxx caused you.
It is important to note that on November 9, 2007, Merck & Co., Inc. announced that it will pay $4.85 billion into a fund to settle most lawsuits filed over injuries or deaths allegedly caused by Vioxx. An experienced attorney can advise you on how the creation of this settlement fund might affect your case.
Q: How could I succeed in suing the manufacturer of a drug like Vioxx?
A: While all medications have certain, anticipated side effects, a drug manufacturer has a duty to make its pharmaceutical products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."