Vioxx

What is the most important information I should know about rofecoxib?
• The manufacturer of rofecoxib (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 rofecoxib.
• 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.




What is rofecoxib?
• Rofecoxib is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Rofecoxib works by reducing substances that cause inflammation, pain, and fever in the body.
• Rofecoxib is used to reduce pain, inflammation, and stiffness caused by osteoarthritis, rheumatoid arthritis and certain forms of juvenile rheumatoid arthritis; to manage acute pain in adults; to treat migraines; and to treat menstrual pain.
• Rofecoxib may also be used for purposes other than those listed in this medication guide.




What should I discuss with my healthcare provider before taking rofecoxib?
• The manufacturer of rofecoxib (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 rofecoxib.
• Do not take rofecoxib 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 rofecoxib.
• Before taking rofecoxib, 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 rofecoxib, 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.
• Rofecoxib is in the FDA pregnancy category C. This means that it is not known whether it will harm an unborn baby. Rofecoxib should not be taken late in pregnancy (the third trimester) because it may affect the formation of the baby's heart. Do not take rofecoxib without first talking to your doctor if you are pregnant or could become pregnant during treatment.
• It is not known whether rofecoxib passes into breast milk. Do not take rofecoxib 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 rofecoxib. You may require a lower dosage or special monitoring during treatment.




How should I take rofecoxib?
• Take rofecoxib exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
• Take each dose with a full glass of water.
• Shake the rofecoxib suspension well before measuring a dose. Use a dose-measuring cup or spoon, not a regular table spoon, to measure the liquid form of rofecoxib to ensure that you measure the correct amount of medicine. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
• Rofecoxib can be taken with or without food or milk.
• Store rofecoxib at room temperature away from moisture and heat.




What happens if I miss a dose?
• Take the missed dose as soon as you remember. If it is almost time for the next dose, skip the dose you missed and take only the next regularly scheduled dose as directed. Do not take a double dose of this medication unless your doctor directs otherwise.




What happens if I overdose?
• Seek emergency medical attention.
• Symptoms of a rofecoxib overdose are not known.




What should I avoid while taking rofecoxib?
• There are no restrictions on food, beverages, or activity during treatment with rofecoxib, unless otherwise directed by your doctor.




What are the possible side effects of rofecoxib?
• 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 rofecoxib 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 rofecoxib 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.




What other drugs will affect rofecoxib?
• Before taking rofecoxib, tell your doctor if you are taking any of the following drugs:
· aspirin or an aspirin-like medication such as salsalate (Disalcid), choline salicylate-magnesium salicylate (Trilisate, Tricosal, others), and magnesium salicylate (Doan's, Bayer Select Backache Formula, others);
· an over-the-counter cough, cold, allergy, or pain medicine that contains aspirin, ibuprofen, naproxen, or ketoprofen;
· a diuretic (water pill) such as furosemide (Lasix), hydrochlorothiazide (Hydrodiuril, others), chlorothiazide (Diuril, others), chlorthalidone (Hygroton, Thalitone), and others;
· an angiotensin-converting-enzyme inhibitor (ACE inhibitor) such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), and others;
· a steroid medicine such as prednisone (Deltasone and others), methylprednisolone (Medrol and others), prednisolone (Prelone, Pediapred, and others), and others;
· an anticoagulant (blood thinner) such as warfarin (Coumadin);
· methotrexate (Rheumatrex, Folex);
· theophylline (Theo-Dur, Theobid, and others);
· lithium (Eskalith, Lithobid, others); or
· rifampin (Rimactane, Rifadin, Rifater).
• You may not be able to take an rofecoxib, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with rofecoxib. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.