Vioxx Information

What is Vioxx?

Vioxx is a nonsteroidal anti-inflammatory drug (NSAID) that is used to reduce pain and inflammation (swelling and soreness). Vioxx is available as a tablet or a liquid that you take by mouth. Individuals may take Vioxx for the following conditions:

• relief of osteoarthritis (the arthritis caused by age-related "wear and tear" on bones and joints)
• management of acute pain in adults (like the short-term pain you can get after a dental or surgical operation)
• treatment of menstrual pain (pain during women's monthly periods)

How should I take Vioxx?

Vioxx should be taken once a day. Your physician will decide the appropriate dose of Vioxx that an indivudual should take. Individuals may take Vioxx with or without food.

What should an individual explain to a physician before and during treatment with Vioxx?

Tell your physician if you are:

• pregnant or planning to conceive. Vioxx should not be used in late pregnancy because it may harm the fetus.
• breast-feeding or plan to breast-feed. Currently, it is not known whether Vioxx is passed through to human breast milk and what its effects could be on a nursing child.

Individuals should also inform their physician if they have a history of the following medical conditions:

• heart failure
• liver disease
• kidney disease
• high blood pressure
• had an allergic reaction to aspirin or other NSAIDs

• had stomach complications i.e. ulcers etc.
  • any other medical problems or allergies you have now or have had.
  • all medicines that you are taking or plan to take, even those you can get without a prescription.

  In addition tell your physician if you develop:

  • ulcer or bleeding symptoms (for instance, stomach burning or black stools, which are signs of possible stomach bleeding).
  • unexplained weight gain or swelling of the feet and/or legs.
  • skin rash or allergic reactions. If you have a severe allergic reaction, get medical help right away.

  Who should not take Vioxx?

  Do not take Vioxx if you:

  • have had an allergic reaction such as asthma attacks, hives, or swelling of the throat and face to aspirin or other NSAIDs (for example, ibuprofen and naproxen).
  • have had an allergic reaction to rofecoxib, which is the active ingredient of Vioxx, or to any of its inactive ingredients. (See Inactive Ingredients at the end of this leaflet.)

  What are the possible side effects of Voxx?

  Serious but rare side effects that have been reported in patients taking Vioxx and/or related medicines have included:

  • Serious stomach problems, such as stomach and intestinal bleeding, can occur with or without warning symptoms. These problems, if severe, could lead to hospitalization or death. Although this happens rarely, you should watch for signs that you may have this serious side effect and tell your doctor right away.
  • Serious allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing occur rarely but may require treatment right away. Severe skin reactions have also been reported.
  • Serious kidney problems occur rarely, including acute kidney failure and worsening of chronic kidney failure.
  • Severe liver problems, including hepatitis and jaundice, occur rarely in patients taking NSAIDs, including VIOXX. Tell your doctor if you develop symptoms of liver problems. These include nausea, tiredness, itching, tenderness in the right upper abdomen, and flu-like symptoms.

  In addition, the following side effects have been reported: anxiety, confusion, hair loss, hallucinations, increased levels of potassium in the blood, low blood cell counts, tingling sensation, unusual headache with stiff neck (aseptic meningitis).

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

  Upper and/or lower respiratory infection and/or inflammation
  
  ·         Dizziness
  ·         Diarrhea
  ·         Nausea and/or vomiting
  ·         Heartburn, stomach pain and upset
  ·         Swelling of the legs and/or feet
  ·         High blood pressure
  ·         Back pain
  ·         Tiredness
  ·         Urinary tract infection.
  ·         Headache

  These side effects were reported in at least 2% of osteoarthritis patients receiving daily doses of Vioxx 12.5 mg to 25 mg in clinical studies.

  The side effects described above do not include all of the side effects reported with VIOXX. Do not rely on this leaflet alone for information about side effects. Your doctor or pharmacist can discuss with you a more complete list of side effects. Any time you have a medical problem you think may be related to VIOXX, talk to your doctor.

  Can individuals take Vioxx with other medicines?

  Individuals should inform their physicians concerning all of the other medicines they are taking or plan to take while  on Vioxx. This includes other medicines that individuals can get without a prescription. Your physician may want to check that your medicines are working properly together if you are taking other medicines such as:

  • methotrexate (a medicine used to suppress the immune system)
  • warfarin (a blood thinner)
  • rifampin (an antibiotic)
  • ACE inhibitors (medicines used for high blood pressure and heart failure)
• lithium (a medicine used to treat a certain type of depression).