|Strength(s):||12.5mg & 25mg tablets or 12.5mg/5ml & 25mg/5ml suspension|
|Dosage Form(s):||Tablets and oral suspension|
|Company Name:||Merck & Co., Inc.|
|*Date Approved by the FDA:||May 21, 1999|
|*Approval by FDA does not mean that the drug is available to consumers at this time.|
What is Vioxx used for?
Vioxx is used to relieve:
- Signs and symptoms of osteoarthritis
- Acute pain in adults
- Painful menstrual cycles.
Who should not take Vioxx?
You should not take Vioxx if you have experienced asthma, hives, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). A few examples of other NSAIDs are ibuprofen, naproxen, diclofenac, nabumetone, and ketoprofen.
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
General Precautions with Vioxx:
Do not stop taking any medications that you have been prescribed without first talking to your doctor.
Serious problems such as liver damage have occurred in people treated with NSAIDs. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine. If you experience any of these symptoms, call your health care provider right away.
Vioxx can cause your body to retain fluid and swell. Your health care provider will decide if Vioxx is right for you, if you:
- retain fluids
- have high blood pressure
- have heart failure
If you have asthma, you may have aspirin-sensitive asthma. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. Since this type of reaction to aspirin and other NSAIDs have occurred in aspirin-sensitive patients, Vioxx should not be given to aspirin-sensitive patients.
The safety and effectiveness of Vioxx in patients below the age of 18 years has not been determined.
What should I tell my doctor or health care provider?
Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.
Because certain other medications can interact with Vioxx, review all medications that you are taking with your health care provider, including those that you take without a prescription.
Your health care provider may have to adjust your dose or monitor you more closely if you take:
- certain blood pressure medications called ACE-inhibitors
Avoid taking Vioxx with antacids that contain calcium carbonate and magnesium/aluminum combination products, because they may reduce the amount of Vioxx your body absorbs.
What are some possible side effects of Vioxx? (This is NOT a complete list of side effects reported with Vioxx. Your health care provider can discuss with you a more complete list of side effects.)
Side effects can include:
- Upper respiratory tract infection
- Swelling of the lower legs or feet
- High blood pressure
Rarely, serious ulcers have occurred in patients taking Vioxx.
For more detailed information about Vioxx, ask your health care provider.
Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. Vioxx was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.
Vioxx (rofecoxib) Questions and Answers
1. What action did Merck take today?
Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib).
2. What is Vioxx?
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.
3. Did FDA require this action?
No, Merck made this decision independent of input from FDA. The Agency has not had an opportunity to review the data from the study that was stopped in the depth that Merck has, but agrees with the company that there appear to be significant safety concerns for patients, particularly those taking the drug chronically.
FDA plans to work closely with Merck to coordinate the withdrawal of this product from the US market.
4. What action did FDA take today?
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.
5. What should I do if I am currently taking Vioxx?
The risk that an individual patient will suffer a heart attack or stroke related to Vioxx is very small. We encourage people taking Vioxx to contact their physician to discuss discontinuing use of Vioxx and alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your physician based on an assessment of your specific treatment needs.
6. What are the likely long-term health effects, if any, of taking this product?
The new study shows that Vioxx may cause an increased risk in cardiovascular events such as heart attack and strokes during chronic use.
7. What evidence supports the Public Health Advisory?
Merck’s decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe [ Adenomatous Polyp Prevention on VIOXX] trial. In the APPROVe trial, Vioxx was compared to placebo (sugar-pill). The purpose of the trial was to see if Vioxx 25 mg was effective in preventing the recurrence of colon polyps. This trial was stopped early because there was an increased risk for serious cardiovascular events, such as heart attacks and strokes, first observed after 18 months of continuous treatment with Vioxx compared with placebo.
8. Why wasn’t the APPROVe trial stopped earlier?
The APPROVe trial began enrollment in 2000. The trial was being monitored by an independent data safety monitoring board (DSMB). It was not stopped earlier because the results for the first 18 months of the trial did not show any increased risk of confirmed cardiovascular events on Vioxx.
9. What did FDA know about the risk of heart attack and stroke when it approved Vioxx?
FDA originally approved Vioxx in May 1999. The original safety database included approximately 5000 patients on Vioxx and did not show an increased risk of heart attack or stroke. A later study, VIGOR (VIOXX GI Outcomes Research), was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding and was submitted to the FDA in June 2000. The study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking naproxen, another NSAID, however, the study also showed a greater number of heart attacks in patients taking Vioxx. The VIGOR study was discussed at a February 2001 Arthritis Advisory Committee and the new safety information from this study was added to the labeling for Vioxx in April 2002. Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx.
10. Is FDA’s expedited review process putting riskier drugs on the market?
No. Vioxx received a six-month priority review because the drug potentially provided a significant therapeutic advantage over existing approved drugs due to fewer gastrointestinal side effects, including bleeding. A product undergoing a priority review is held to the same rigorous standards for safety, efficacy, and quality that FDA expects from all drugs submitted for approval.
11. What other drugs are similar to Vioxx?
Vioxx is a COX-2 selective, nonsteroidal anti-inflammatory drug (NSAID). Other COX-2 selective NSAIDs on the market at this time are Celebrex (celecoxib) and Bextra (valdecoxib). 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.
12. Does today’s action suggest that other drugs in the same class are dangerous?
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.
13. Will Vioxx be recalled?
FDA did not request a recall of Vioxx. This product is being voluntarily withdrawn from the market by Merck.
14. Can my pharmacist continue to fill my prescription for Vioxx?
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.
15. How can I report a serious side effect with Vioxx to FDA?
FDA encourages anyone aware of a serious adverse reaction to make a MedWatch report. You can report an adverse event in two ways:
Visit www.fda.gov/medwatch and click on "How to Report"
16. Where can I get more information?
You can obtain more information from Merck at:
www.merck.com and www.vioxx.com , or