About Vioxx

Vioxx is a prescription pain reliever used for Osteoarthritis, Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, severe menstrual cycles and migraines. Vioxx is an NSAID drug (NonSteroidal Anti-inflammatory Drug). It is a COX-2 inhibitor that claimed to have less gastrointestinal problems than other NSAIDs such as aspirin.

Vioxx has been on the market since 1999. Its generic name is rofecoxib.


Serious side effects that may occur while taking Vioxx

Patients that have been taking VIOXX have reported serious, potentially life-threatening side effects, including:

Serious stomach problems with or without warning symptoms. Watch for symptoms such as stomach burning, vomiting blood, blood in your bowl movement or black, tar-like bowel movements. Call your doctor immediately if you or your children experience any of these symptoms, as they could lead to hospitalization or death.

Get emergency help immediately if any of these serious allergic reactions occur:

  • swelling of the face, lips or tongue
  • breathing problems including chest tightness, shortness of breath, wheezing
  • swallowing difficulties
  • hives
  • loss of blood pressure and consciousness
  • Heart attacks, blood clots and stroke have been reported in patients taking Vioxx.
  • Acute kidney failure and worsening of chronic kidney failure can occur while taking Vioxx.
  • Severe liver problems can occur while using Vioxx. Call your doctor if you or your child experience nausea, itching, pain in the right upper abdomen, yellow skin or eyes, or flu-like symptoms.

Less serious side effects that may occur while taking Vioxx:

  • 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
  • anxiety
  • palpitations
  • pancreatitis
  • ringing in the ears
  • severe increase in blood pressure
  • blurred vision
  • colitis
  • confusion
  • constipation
  • decreased levels of sodium in the blood
  • depression
  • fluid in the lung
  • hair loss
  • hallucinations
  • increased levels of potassium in the blood
  • insomnia
  • low blood cell counts
  • menstrual disorders
  • skin reactions to sunlight
  • unusual headache with stiff neck
  • vertigo

Talk to your doctor or pharmacist about any symptoms you or your child may be experiencing while taking Vioxx.

Health Canada approved Vioxx in 1999 as a treatment to reduce the pain and inflammation caused by osteoarthritis, rheumatoid arthritis, acute pain, and menstrual pain. It was approved in the U.S. prior to that by the American Food and Drug Administration (“FDA”).

Since its introduction, concerns have been raised about side effects of Vioxx. In June 2000, the makers of Vioxx submitted a safety study to the FDA entitled “Vioxx Gastrointestinal Outcomes Research” that found an increased risk of serious cardiovascular events, including heart attacks, and strokes in patients taking Vioxx. As a result, in April, 2001, the FDA implemented labeling changes which included information about theses increased risks. Dr. David Graham, and FDA investigator, made a report to a public conference in August 2004, about the dangers of Vioxx.

Other studies recently suggested an increased risk of cardiovascular events, and the FDA was in the process of reviewing these studies to determine if further labeling changes were needed.

On September 30, 2004, the manufacturer of Vioxx voluntarily withdrew it from the market after the data safety monitoring board of the FDA that was performing a study recommended that the study be halted because of an increased risk of serious cardiac events, including heart attack and strokes. The risk was approximately twice that of individuals taking a placebo.

For more information, please call (204) 957-1456.