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REVISED PROCEDURE FOR PATIENTS SEEKING A REFUND FOR UNUSED VIOXX® (rofecoxib)
If you are a patient who took VIOXX, you may be eligible to receive a refund for the amount you paid out-of-pocket for VIOXX that remained unused as of September 30, 2004.

Merck strongly recommends that you return any unused VIOXX to the National Notification Center (NNC) in accordance with the instructions below.

However, if you have already destroyed or disposed of your unused VIOXX, or cannot return it in its original container, you may still be eligible to receive a refund under new procedures adopted by Merck.

To receive a refund for the amount you paid out-of-pocket for VIOXX that remained unused as of September 30, 2004, please call the National Notification Center (NNC) at 1-800-805-9542. Patients who call that number will receive a Patient Return Kit directly from NNC which may be returned via UPS (United Parcel Service). The return kit includes a shipping container and a prepaid UPS shipping label, with complete instructions. Completed return kits can be placed into a UPS drop or delivered to a UPS drop-off location, or the patient can arrange for pick-up by calling UPS at 1-800-PICK-UPS. Refunds may take up to 12 weeks from the time that NNC receives the completed refund request.

If you have already destroyed or disposed of your unused VIOXX, you may still be eligible to receive a refund. You must call NNC to obtain a new Patient Return Kit, which contains complete instructions, as the requirements for refund under these circumstances have changed.

Patients who cannot return their unused VIOXX are required to sign and submit certain forms contained in the Patient Return Kit. In addition, for such patients the following restrictions apply (these restrictions apply only to patients who cannot return their unused VIOXX):

You must submit a valid pharmacy receipt indicating that the prescription was dispensed:

On or after August 1, 2004, for a 30-day supply of 12.5-mg or 25-mg VIOXX
On or after June 1, 2004, for any amount greater than a 30-day supply of 12.5-mg or 25-mg VIOXX
On or after June 1, 2004, for any amount of 50-mg VIOXX
All patients seeking a refund for unused VIOXX must phone their request for a Patient Return Kit to NNC (1-800-805-9542) by March 31, 2005, and the Patient Return Kit with required documents must be complete and postmarked or received by UPS no later than May 16, 2005, in order to be eligible for a refund. Refund requests postmarked or received by UPS after May 16, 2005, will not be eligible for a refund.

If you have previously submitted a refund request through NNC and did not include the unused portion of VIOXX in its original container, NNC will contact you to obtain any additional information needed to process your return.

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Instructions for patients on how to receive refund for unused VIOXX [PDF: 8 KB, 1 page]
In order to view PDF documents, you must have the Adobe Acrobat Reader installed on your computer.
This reimbursement information applies exclusively to residents of the United States, its territories and Puerto Rico. All other visitors should contact their local Merck Sharp and Dohme (MSD) subsidiary.

Arthritis patients who took Vioxx seek other ways to lessen pain

Abe Aamidor
The Indianapolis Star
Jan. 9, 2005 - Sue Nichols was diagnosed with osteoarthritis six years ago. Not so good, but not so bad, either, as a new wonder drug, Vioxx, proved highly effective in helping Nichols control her pain.

Yet she was back to square one this fall when manufacturer Merck & Co. pulled Vioxx from the market after it was linked to heart attacks in some patients.

"You don't want to stop taking something that works," says Nichols, a 54-year-old pharmacy technician from Carmel, Ind. Like many other patients, however, she was switched to a different drug.

The 40 million Americans who suffer from arthritis were dealt another blow in December when Pfizer Inc., the maker of the arthritis drug Celebrex, said its popular pain reliever may double the risk of heart attack at high doses. Pfizer did not pull its drug off the market, but the announcement triggered a torrent of new warnings about cox-2 inhibitors such as Celebrex and Vioxx.

Now, people like Nichols are seeking replacement therapies - whether a different drug, a redoubled exercise regimen, an alternative medicine approach or some combination of treatments.

Nichols' rheumatologist, Dr. Douglas Smith, switched her from Vioxx to Mobic - a drug that is in between an older class of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs include aspirin and ibuprofen) and the newer cox-2 inhibitors such as Vioxx and Celebrex - and an additional medicine to help protect her stomach.

Most people prescribed cox-2 inhibitors such as Vioxx, Celebrex or Bextra have ulcers or other gastrointestinal problems that prevent them from using the older NSAIDs.

The newer drugs work by stopping cox-2 enzymes. These enzymes are produced naturally in the body, and blocking them impedes the body's production of chemical messengers called prostaglandins. It is the prostaglandins that are directly associated with the pain and swelling of arthritis.

An alternative to both cox-2 inhibitors and NSAIDs is Tylenol (acetaminophen).

"If indeed they can get by with Tylenol, then I think that would be a good alternative," says Dr. Matthew French, an interventional cardiologist with the Care Group at St. Vincent Hospital in Indianapolis.

Physical therapy also is an option to complement drug therapy, and most insurance plans will cover a short series of treatments.

Kelly Rickert, a physical therapist at the Rehabilitation Hospital of Indiana, says the goal of therapy is to increase flexibility and strength in the affected joints and surrounding soft tissue.

A specific program has to be prescribed by a physician, she says. Once on a program, it will be up to the patient to continue exercises at home on a daily basis where possible.

A popular health-food store remedy that shows some promise is glucosamine chondroitin. Dr. Palmer MacKie, an assistant professor at the Indiana University School of Medicine and a specialist in alternative medicine, says this natural compound offers some pain relief and may retard progression of joint disease. Yet individual trials over the years have been inconclusive, and critics note that there is little or no regulation of such supplements.

Weight loss can be a boon to people with arthritis, too.

"The clinical improvement in a patient with osteoarthritis may come with a weight reduction of as little as six or seven pounds," says Dr. Ken Brandt, professor of medicine and orthopedic surgery at the IU School of Medicine.

MacKie says he has tried acupuncture on arthritic patients, but with only mixed results. A recent report in the British Medical Journal says acupuncture in conjunction with pain medicines provides more relief for osteoarthritis in the knee than pain medicine alone does.

Surgery usually is the last option considered because it is so invasive. Nevertheless, it can be very effective.

But it's not a step to be taken lightly. For example, only when the protective cartilage in the knee is worn away and the pain and swelling are too great to function normally would one opt for a complete knee joint replacement. Risks of surgery include infection, blood clots and stiffness or loosening in the joint.

Though Vioxx is off the market, one unanswered question is whether the risk of heart attack reverts to previous levels once use is stopped. Experts say only careful monitoring of former users will tell, but that they believe the risk will indeed subside.

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