Frequently Asked Questions (FAQs)

VIOXX

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1. What is VIOXX® and what is it prescribed for?
VIOXX® is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by the Food and Drug Administration (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. It is also approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.

2. What are the dangers associated with the use of VIOXX®?
Studies have shown an increased risk of cardiovascular events (including heart attack and stroke) in patients taking VIOXX®, particularly those who have been taking the drug for longer than 18 months. Patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo. VIOXX® has also been linked to an increased risk of blood clots and kidney failure.

3. May I still fill my VIOXX® prescription?
No. The FDA was informed by Merck & Co., Inc. on September 27, 2004, that the Data Safety Monitoring Board for an ongoing long-term study of VIOXX® (APPROVe) had recommended that the study be stopped early for safety reasons. The study was being conducted in patients at risk for developing recurrent colon polyps. Based on this new safety information, Merck and FDA officials met September 28, 2004, and during that meeting the FDA was informed that Merck was voluntarily withdrawing VIOXX® from the market place. Merck & Co., Inc. announced September 30th a voluntary withdrawal of VIOXX® (chemical name rofecoxib) from the U.S. market due to safety concerns. You can read the VIOXX® withdrawal press release from Merck here.

4. Was September 27, 2004 the first warning Merck & Co., Inc. had of problems with VIOXX®?
No. As far back as June 2000, Merck submitted to the FDA a safety study called VIGOR (VIOXX® Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking VIOXX® compared to patients taking naproxen. In August 2001, VIOXX® was linked to an increase in the risk of blood clots, heart attacks and strokes based on a review and analysis of previous clinical trials. The FDA sent Merck a warning letter dated September 17, 2001. You can read the FDA's warning letter issued to Merck & Co., Inc. here. The letter demanded that Merck discontinue promoting VIOXX® to doctors for unofficial uses. It also required Merck to send letters about the deception to the medical community. In April 2002, after reviewing the results of the VIGOR study and other available data from controlled clinical trials, the FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke. The drug remained on the market, however, and no action was taken by Merck & Co., Inc.

5. What action has the FDA taken?
The FDA has 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.

6. What should I do if I am currently taking VIOXX®?
People taking VIOXX® are encouraged 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.

7. What other drugs are similar to VIOXX®?
VIOXX® is a COX-2 selective, non-steroidal 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.

8. Does the FDA'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.

9. What should I do if I think I have been injured as a result of taking VIOXX®?
If you or a loved one are currently taking or have taken VIOXX®, you may be at risk for serious or fatal health problems. Please seek medical attention immediately. If you have suffered a heart attack, stroke, or other cardiac event as a result of taking VIOXX®, contact the experienced personal injury attorneys at Ziff, Weiermiller, Hayden & Mustico to discuss your VIOXX® injury case. We offer a FREE CONSULTATION FOR VIOXX CASES.

10. How could I succeed in suing the manufacturer of a drug like VIOXX®?
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 known as products liability. An experienced products liability attorney can assist you in determining whether you have a viable claim, and advise you how to protect your right to sue for damages caused by the use of VIOXX®. The smart, aggressive, local attorneys at Ziff, Weiermiller, Hayden & Mustico have more than 50 years experience handling products liability cases for the injured and are now accepting VIOXX® cases.

11. How can I contact Ziff, Weiermiller, Hayden & Mustico?
The tough, experienced and aggressive attorneys at the Ziff Law Firm may be contacted by telephone toll free at 1-800-ZIFFLAW or locally at (607) 733-8866. Our website may be visited at www.zifflaw.com. E-mail inquiries may be sent to info@zifflaw.com. Our offices are located at 303 William Street, Elmira, New York, 14901. Please call to schedule an appointment with one of our attorneys today. To make it easy to provide information regarding your possible Vioxx case, we have created a Vioxx Questionnaire that permits you to quickly E-mail us the basic information about your Vioxx use and any injuries you may have suffered.

13. How can I report a serious side effect with VIOXX® to the 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" or Call 1-800-FDA-1088.

14. Where can I get more information?
You can obtain more information from Merck at: www.merck.com and www.vioxx.com, or
1-888-36VIOXX (1-888-368-4699)

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To find out more about VIOXX® from FDA, visit their Drug Information web page at: www.fda.gov/cder or call Drug Information at: 888-INFO-FDA (888-463-6332).

Consult with your physician if you have questions concerning this medication. The above is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

Vioxx® is a registered trademark of Merck & Co., Inc.

Celebrex® and Bextra® are registered trademarks of Pfizer, Inc.

Please see our webpage on Vioxx for more information.