Vioxx Faq
What did the FDA know about the risk of heart attack and stroke when it approved Vioxx?
The FDA originally approved Vioxx in May 1999. The original safety data included approximately 5,000 patients taking Vioxx and did not show an increased risk of heart attack or stroke. A later study, VIGOR, 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 the over-the-counter drug naproxen. 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 long-term use of Vioxx.
What other drugs are similar to Vioxx?
Vioxx is related to the over-the counter NSAIDs aspirin, ibuprofen, ketoprofen, and naproxen; the prescription NSAIDs Celebrex and Bextra (also called Cox-2 inhibitors); and several other drugs. None of these similar drugs has been withdrawn.
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 doctor.
Will Vioxx be recalled?
The FDA did not request a recall of Vioxx. This product is being voluntarily withdrawn from the market by Merck.
Can my pharmacist continue to fill my prescription for Vioxx?
No. Merck is initiating a market withdrawal in the U.S. to the pharmacy level. This means Vioxx will no longer be available at pharmacies.
How can I report a serious side effect with Vioxx to the FDA?
The 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"
- Call (800) FDA-1088
Where can I get more information?
You can obtain more information from Merck at:
- www.merck.com and www.vioxx.com, or
- (888) 36VIOXX ((888) 368-4699)
To find out more about Vioxx from the FDA:
- Visit the FDA's Drug Information web page at: www.fda.gov/cder
- Call Drug Information at (888) INFO-FDA ((888) 463-6332)
SOURCES: FDA. WebMD Drug Reference from Multum Information Services: "Rofecoxib (oral)."
1
|
2
|
|
Vioxx Resources
Merck
U.S. Food and Drug Administration
|
