Vioxx

Vioxx was withdrawn from the U.S. market in 2004.

The manufacturer of Vioxx has announced a voluntary withdrawal of the drug from the U.S. and worldwide market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking Vioxx.

Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; blood in your vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of your skin or eyes;"flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.

The manufacturer of Vioxx has announced a voluntary withdrawal of the drug from the U.S. and worldwide market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking Vioxx.

Do not take Vioxx without first talking to your doctor if you have experienced asthma, hives, or an allergic reaction after taking aspirin or another NSAID such as ibuprofen (Motrin, Advil, Nuprin), naproxen (Aleve, Naprosyn, Anaprox), ketoprofen (Orudis KT, Orudis, Oruvail), diclofenac (Voltaren, Cataflam), diflunisal (Dolobid), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), sulindac (Clinoril), tolmetin (Tolectin), celecoxib (Celebrex), valdecoxib (Bextra), or meloxicam (Mobic). You may experience a similar reaction to Vioxx.

Before taking Vioxx, tell your doctor if you

• smoke;

• drink alcohol;

• have ever had an ulcer or bleeding in your stomach;

• have liver disease;
• have kidney disease;

• have asthma;

• have congestive heart failure;

• have fluid retention;

• have heart disease;

• have high blood pressure;

• have a coagulation (bleeding) disorder or are taking an anticoagulant (blood thinner) such as warfarin (Coumadin); or

• are taking a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others.

You may not be able to take Vioxx, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions, or are taking any of the medicines, listed above.

Vioxx is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Vioxx should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take Vioxx without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether Vioxx passes into breast milk. Do not take Vioxx without first talking to your doctor if you are breast-feeding. If you are over the age of 65 years, you may be more likely to experience side effects from Vioxx. You may require a lower dosage or special monitoring during treatment.

There are no restrictions on food, beverages, or activity during treatment with Vioxx, unless otherwise directed by your doctor.

Notify your doctor immediately if you develop abdominal pain, tenderness, or discomfort; nausea; blood in your vomit; bloody, black, or tarry stools; unexplained weight gain; swelling or water retention; fatigue or lethargy; a skin rash; itching; yellowing of your skin or eyes;"flu-like" symptoms; or unusual bruising or bleeding. These symptoms could be early signs of dangerous side effects.

If you experience any of the following serious side effects, stop taking Vioxx and seek medical treatment or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);

• abdominal pain, tenderness, or discomfort;

• bloody, black, or tarry stools;

• nausea or heartburn;

• blood in your vomit;

• unexplained weight gain;

• swelling or water retention;

• unusual fatigue or lethargy;

• a skin rash or itching;

• yellowing of your skin or eyes;

• "flu-like" symptoms; or

• unusual bruising or bleeding.

Other, less serious side effects may be more likely to occur. Continue to take Vioxx and talk to your doctor if you experience

• dizziness;

• mild fatigue or weakness; or

• diarrhea.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

• Your pharmacist has additional information about Vioxx written for health professionals that you may read.

Vioxx was withdrawn from the U.S. market in 2004.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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