On Thursday, September 30, 2004, Merck announced a voluntary worldwide withdrawal of Vioxx after a study found that it doubled the risk of cardiovascular events including heart attack, stroke, and blood clots.

Merck’s decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe [ Adenomatous Polyp Prevention on VIOXX] trial.  In the APPROVe trial, Vioxx was compared to placebo (sugar-pill).  The purpose of the trial was to see if Vioxx 25 mg was effective in preventing the recurrence of colon polyps.  This trial was stopped early because there was an increased risk for serious cardiovascular events, such as heart attacks and strokes, first observed after 18 months of continuous treatment with Vioxx compared with placebo.

What are the possible side effects of VIOXX?

Serious but rare and potentially life-threatening side effects that have been reported in patients taking
VIOXX include:

• Serious stomach problems, such as stomach and intestinal bleeding, can happen with or without warning symptoms. These problems, if serious, could lead to hospitalization or death. Although this
  does not happen often, you should watch for the signs and symptoms (for instance, stomach burning, vomiting blood, or if there is blood in the bowel movement or it is black and sticky like tar). Call your doctor right away if you or your child have any of these serious side effects.
  
• Serious allergic reactions include the symptoms and signs of swelling of the face, lips, tongue; trouble breathing such as chest tightness or shortness of breath; trouble swallowing; hives; wheezing; or shock (loss of blood pressure and consciousness). Get emergency help right away if you get any of these symptoms or signs. Serious skin reactions have also been reported.
  
• Heart attacks and other serious cardiovascular events, such as blood clots in your body have been reported in patients taking VIOXX.
  
• Serious kidney problems can happen, including acute (sudden) kidney failure and worsening of chronic kidney failure.
  
• Severe liver problems, including hepatitis, jaundice and liver failure, can occur. Call your doctor if you or your child gets any of these symptoms of liver problems. These include: nausea; itching; pain in the right upper abdomen; yellow skin or eyes; or flu-like symptoms. Your doctor may do blood tests and check you or your child for problems that may happen during treatment with VIOXX.

More common, but less serious side effects reported with VIOXX have included the following:

• Respiratory infections
  
• Headache
  
• Dizziness
  
• Diarrhea
  
• Nausea, vomiting and upset stomach
  
• Heartburn
  
• Stomach pain
  
• Swelling of the legs and/or feet
  
• High blood pressure
  
• Back pain
  
• Tiredness
  
• Urinary tract infection.

In addition, the following side effects have been reported: anxiety, blurred vision, colitis, confusion, constipation, decreased levels of sodium in the blood, depression, fluid in the lungs, hair loss, hallucinations, increased levels of potassium in the blood, insomnia, low blood cell counts, menstrual disorder, palpitations, pancreatitis, ringing in the ears, severe increase in blood pressure, skin reactions caused by sunlight, tingling sensation, unusual headache with stiff neck (aseptic meningitis), vertigo, worsening of epilepsy.

 

Who should not take VIOXX?

• People who have had an allergic reaction such as asthma attacks (wheezing), hives, or swelling of the throat and face to aspirin or other medicines called non-steroidal anti-inflammatory drugs (NSAIDs). There are many NSAID medicines. Ask the doctor or pharmacist for a list of medicines that contain NSAIDs if you are not sure.
  
• People who are allergic to rofecoxib, the active ingredient of VIOXX, or to any other ingredients in VIOXX. See the
  end of this leaflet for a complete list of ingredients in VIOXX.

Be sure to tell your doctor if you:

• have ever had liver problems;
• are taking any other medicine, vitamin supplement, or herbal remedy, including those sold without a prescription (over-the-counter);
• have heart problems or have had a heart attack or stroke;
• have had manic episodes (extreme agitation or excitability);
• have ever attempted suicide;
• have had convulsions (seizures);
• are pregnant or breast-feeding.