VIOXX FAQ
| Q: |
What action did Merck take today? |
| A: |
Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib).
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| 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.
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| Q: |
Did FDA require this action? |
| A: |
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.
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| Q: |
What action did FDA take today? |
| 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.
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| Q: |
What should I do if I am currently taking Vioxx? |
| A: |
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.
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| Q: |
What are the likely long-term health effects, if any, of taking this product? |
| A: |
The new study shows that Vioxx may cause an increased risk in cardiovascular events such as heart attack and strokes during chronic use.
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| Q: |
What evidence supports the Public Health Advisory? |
| A: |
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.
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| Q: |
Why wasn't the APPROVe trial stopped earlier? |
| A: |
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.
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| Q: |
What did FDA know about the risk of heart attack and stroke when it approved Vioxx? |
| A: |
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.
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| Q: |
Is FDA's expedited review process putting riskier drugs on the market? |
| A: |
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.
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| 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 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.
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| Q: |
Does today's action 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.
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| Q: |
Will Vioxx be recalled? |
| A: |
FDA did not request a recall of Vioxx. This product is being voluntarily withdrawn from the market by Merck.
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| Q: |
Can my 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.
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| Q: |
How can I report a serious side effect with Vioxx to FDA? |
| A: |
FDA encourages anyone aware of a serious adverse reaction to make a MedWatch report. You can report an adverse event in two ways:
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| Q: |
Who takes Vioxx? |
| A: |
The drug, which came on the U.S. market in 1999, is approved for the treatment of osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, pain and migraine attacks.
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| Q: |
Why did Merck decide to take it off the market? |
| A: |
Although there had been earlier suggestions of a problem, new data from a study of 2,600 patients who had had colon polyps spurred the withdrawal.
The patients were randomly assigned to take either 25 milligrams of Vioxx or a placebo.
This type of study, called a randomized controlled trial, is considered the gold standard of research in patients. Such studies minimize the chance that something inherent in the patients, rather than the medication in question, leads to the findings.
Merck was looking to see whether Vioxx reduced the chance of a recurrence of the polyps, which can become cancerous. But the study's data safety monitoring board, made up of outside experts, last week recommended halting it because the patients on Vioxx were twice as likely to suffer a heart attack or stroke as those on placebo.
The actual risk was 3.5% in the Vioxx group, compared with 1.9% in the placebo group, according to the FDA. The difference became apparent only after 18 months of treatment.
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| Q: |
Why did Vioxx lead to the higher rate of heart attack and stroke? |
| A: |
Scientists aren't sure. Vioxx and other so-called COX-2 inhibitors are known to raise blood pressure, but that did not appear to be the cause of the cardiovascular findings in the polyps study, says Steven Galson, acting director of FDA's Center for Drug Evaluation and Research.
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| Q: |
Does the risk of heart attack and stroke diminish after patients stop taking Vioxx? |
| A: |
That isn't yet known. Galson says patients in the polyps trial will continue to be followed to see if and when the Vioxx group's risk falls to the same level as the placebo group's.
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| Q: |
What does this mean for Celebrex or Bextra, the other two drugs in the class known as COX-2 inhibitors? |
| A: |
A study reported at a scientific meeting in late August suggests that Celebrex might be safer than Vioxx from a cardiovascular perspective, but questions remain.
David Graham, an FDA scientist, was the lead researcher on that study, which involved nearly 1.4 million Kaiser Permanente members. The study, which was not a randomized trial, found that patients who took a daily Vioxx dose of 25 milligrams or less were more likely to suffer a heart attack or sudden cardiac death than those taking Celebrex.
In a statement Thursday, Pfizer, maker of Celebrex and the less-prescribed Bextra, stood by its products.
However, Garret FitzGerald, who is chairman of pharmacology at the University of Pennsylvania, says that he believes the finding of an elevated risk of heart attacks and strokes applies to all COX-2 inhibitors.
FitzGerald theorizes that trials of Celebrex and Bextra did not reveal the problem because, unlike the Vioxx trials, they allowed participants to take aspirin, too, which has proved to reduce the risk of cardiovascular problems.
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| Q: |
Why have Vioxx and Celebrex been so popular? |
| A: |
Although the drugs cost far more than other generic pain relievers, they have been among the top-selling drugs of all time.
Yet, no one has ever claimed that the COX-2 inhibitors are more effective than their cousins, the conventional nonsteroidal anti-inflammatory drugs, or NSAIDs, such as aspirin, ibuprofen and naproxen.
But years before they came on the market, they were touted as "super aspirins" that were supposed to be kinder to the digestive tract than conventional NSAIDs. The FDA has allowed only Merck to claim that Vioxx is less risky to the digestive tract, and then only that it is less risky than one NSAID, naproxen.
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| Q: |
What should patients do if they're currently taking Vioxx? |
| A: |
Merck is advising patients to talk to their doctors about stopping Vioxx and possibly starting an alternative treatment.
Patients, doctors, nurses and pharmacists can find more information at www.merck.com and www.vioxx.com or by calling 888-368-4699. Merck says it will reimburse all patients for their unused Vioxx; specifics on how to get a refund are on the Web site.
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Information gathered from USA Today
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