Habbas & Associates
Because Experience Matters
VIOXX
Merck announced the voluntary withdrawal of the arthritis pain killer Vioxx from the market September 30, 2004. The news was welcomed by the US Food and Drug Administration, which had raised concerns about the safety of the drug after a study showed an increased risk of strokes and heart attacks.
"Merck did the right thing by promptly reporting these findings to the FDA and voluntarily withdrawing the product from the market," said acting FDA Commissioner Lester Crawford in an FDA press release dated September 30, 2004.
The FDA had released a public health advisory to inform patients of the withdrawal and to consult with a physician about alternative medications. The FDA also released Questions & Answers regarding the withdrawal of Vioxx, excerpts of which are below.
An Estimated 160,000 at Risk for Heart Attacks and Strokes
Eric J. Topol, MD of the Cleveland Clinic cardiology department wrote in an editorial for the New England Journal of Medicine that he estimated there are 160,000 Vioxx users at risk for heart attack or stroke.
Free Case Evaluation
Please contact us toll-free at (866) 995-9993 for a free case evaluation. There is no fee unless we obtain money for you.
What is Vioxx?
Vioxx is a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs are a large group of drugs that include aspirin, ibuprofen, and naproxen, but these drugs are not part of the withdrawal. Vioxx works by reducing substances that cause inflammation, pain, and fever in the body and is used to treat arthritis, acute pain in adults, and painful menstrual cycles.
Why has Vioxx been withdrawn?
New research shows that Vioxx may cause an increased risk of cardiovascular events such as heart attack and stroke if used long-term.
Did the FDA require this action?
No. Merck made this decision independent of input from the FDA. But the FDA agrees with the company that there appears to be significant safety concerns for patients, particularly those taking the drug long-term. The FDA plans to work closely with Merck to coordinate the withdrawal of this product from the U.S. market.
What should I do if I am 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 doctor to discuss discontinuing the use of Vioxx and finding alternative treatments. Any decision about which drug product to take to treat your symptoms should be made in consultation with your doctor based on an assessment of your specific treatment needs.
What evidence supports the withdrawal?
Merck's decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe trial. In the APPROVe trial, Vioxx was compared with placebo (sugar pill). The purpose of the trial was to see if the 25 mg dose of Vioxx was effective in preventing the recurrence of colon polyps. This trial was stopped early because there was an increased risk of serious cardiovascular events, such as heart attack and stroke, after 18 months of continuous treatment with Vioxx.
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. It was not stopped earlier because the results for the first 18 months of the trial did not show any increased risk of cardiovascular events from taking Vioxx.
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.
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.
________________________________________
SOURCES: FDA. WebMD Drug Reference from Multum Information Services: "Rofecoxib (oral)."
