VIOXX® (rofecoxib)

Vioxx is a non-steroidal anti-inflammatory drug (NSAID) that is used in the treatment of generalized pain, as well as the treatment of inflammation and stiffness of arthritis.

MERCK VOLUNTARILY WITHDRAWS VIOXX® (rofecoxib)

Merck & Co., Inc. announced a voluntary withdrawal of VIOXX ® . This decision is based on new data from a three-year clinical study. In this study, there was an increased risk for cardiovascular (CV) events, such as heart attack and stroke, in patients taking VIOXX 25 mg compared to those taking placebo (sugar pill). While the incidence of CV events was low, there was an increased risk beginning after 18 months of treatment. The cause of the clinical study result is uncertain.

Patients who are currently taking VIOXX should contact their health care providers to discuss discontinuing use of VIOXX and possible alternative treatments. In addition, patients and health care professionals may obtain information from merck.com and vioxx.com or may call 1-888-368-4699.

Merck will reimburse all patients for their unused VIOXX. All dosage strengths and formulations of VIOXX are affected by this voluntary withdrawal. Click here for refund information.

The usual dose of Vioxx for acute pain syndromes and menstrual cramps (primary dysmenorrhea) is 50 mg once daily for no longer than 5 days. The usual dose of Vioxx for treatment of osteoarthritis is 12.5 mg daily although some patients may benefit from 25 mg daily. The maximum daily dose should not exceed 25 mg. Vioxx may be taken on an empty stomach or with food. STORE VIOXX at room temperature at 77 degrees F (25 degrees C) in a tightly-closed container, away from heat, moisture, and light. IF YOU MISS A DOSE OF VIOXX and you are taking 1 dose daily, take the missed dose if you remember the same day. Skip the missed dose if you do not remember until the next day. DO NOT take 2 doses of Vioxx at once.

SIDE EFFECTS that may occur while taking Vioxx include weakness or nausea. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience itching or skin rash, swelling of the feet or ankles, unexpected weight gain, vomiting material that looks like coffee grounds, or blood in stool or vomit. CONTACT YOUR DOCTOR IMMEDIATELY if you experience swelling of hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; hoarseness; flu-like symptoms; sluggishness; yellowing of the skin or eyes; stomach pain; dark urine or pale stools; or unusual fatigue. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

DO NOT TAKE VIOXX IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to aspirin or any medicine containing aspirin or to a nonsteroidal anti-inflammatory drug (such as Feldene, Motrin, Naprosyn, Clinoril). A severe reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to Vioxx or if a certain medicine is a nonsteroidal anti-inflammatory drug, contact your doctor or pharmacist. IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of Vioxx unless your doctor tells you to do so. DO NOT EXCEED THE RECOMMENDED DOSE or take Vioxx for longer than prescribed without checking with your doctor. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using Vioxx. ALCOHOL WARNING: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Vioxx or other pain relievers/fever reducers. This medicine may cause stomach bleeding. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. This includes any medicines that contain ibuprofen, naproxen, or ketoprofen. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using Vioxx during pregnancy. IT IS UNKNOWN IF VIOXX IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking Vioxx.

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.