The following information is provided by Script Care concerning the voluntary withdrawal from the market of Vioxx® by Merck and Company:
Background: September 30, 2004 - The U.S. Food and Drug Administration (FDA) acknowledged the voluntary withdrawal from the market of Vioxx® (chemical name rofecoxib), a non-steroidal anti-inflammatory medicine (NSAID) manufactured by Merck & Co. FDA also issued a Public Health Advisory today to inform patients of this action and to advise them to consult with a doctor about alternative medicines. Merck has advised both retail and mail service pharmacies to discontinue dispensing this product.
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 medicine (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 FDA has not had an opportunity to complete an in depth review of the data from the study that was stopped by Merck, but agrees with the company that there appears to be significant safety concerns for patients, particularly those taking the medicine chronically.
FDA plans to work closely with Merck to coordinate the withdrawal of this product from the U.S. 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 people currently taking Vioxx do?
We encourage people taking Vioxx to contact their doctor to discuss the use of Vioxx and which alternative treatments may be appropriate. Any decision about which medicine product to take to treat your symptoms should be made in consultation with your doctor based on an assessment of your specific treatment needs.
6. What other medicines are similar to Vioxx?
Vioxx is a COX-2 selective, nonsteroidal anti-inflammatory medicine (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 doctor to determine which treatment is right for you.
7. Does today's action suggest that other medicines in the same class are dangerous?
The results of clinical studies with one medicine in a given class do not necessarily apply to other medicines 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 medicines for a long period of time (longer than two weeks) should be under the care of a doctor. Please check the package insert with your medicine for any additional information.
8.Will Vioxx be recalled?
FDA did not request a recall of Vioxx. This product is being voluntarily withdrawn from the market by Merck.
9. Can a pharmacist continue to fill a 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.
10. I just received my shipment of Vioxx and have not started using it. What should I do with my prescription?
Contact your doctor for further direction. If your doctor instructs you to return the product. Merck & Co. has advised us that they will be accepting returned product and providing reimbursement for shipping costs associated with the product return and the co-payment incurred to plan participants. For further information or to obtain the required return forms, the plan participant should access either www.Merck.com or www.vioxx.com. You may also contact Merck toll-free at:
11. 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"
· Call 1-800-FDA-1088
12. 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)
To find out more about Vioxx from FDA:
· Visit their Drug Information web page at: www.fda.gov/cder
· Call Drug Information toll-free at: 1-888-INFO-FDA
13. Is Vioxx on the Preferred Drug List?
Yes, it was printed on the new PDL's for October, 2004. It is being removed from the website and will not appear on future PDL's.
14. Are there alternatives for Vioxx on the PDL?
Yes. There are nonspecific nonsteroidal anti-inflammatory in both brand and generic form. There are also two Cox-2 anti-inflammatory medicines, Celebrex® and Bextra®, that have an equivalent co-pay charge.
15. What can a plan participant do with a dispensed Vioxx prescription if their healthcare provider advises them to discontinue use?
Merck & Co. has advised us that they will be accepting returned product and providing reimbursement for shipping costs associated with the product return and the co-payment incurred to plan participants. For further information or to obtain the required return forms, the plan participant should access either www.Merck.com or www.vioxx.com . They may also contact Merck toll-free at: 1-888-368-4699.
Merck will reimburse patients for unused VIOXX® (rofecoxib).
Patients seeking a refund should return any unused VIOXX tablets and oral suspension via regular US mail to the following address:
Patients must include the following information when returning any unused VIOXX tablets and oral suspension:
Name, address, and phone number
Unused product in its original pharmacy packaging
Pharmacy receipt corresponding to returned product
Patients will receive a full refund of the price paid as reflected on their pharmacy receipt, plus the cost of shipping via regular US mail.
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