The manufacturer of Vioxx (also called Rofecoxib) 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 problems in patients.
Vioxx is in a class of drugs called Nonsteroidal Anti-inflammatory Drugs (NSAIDs). Vioxx works by reducing substances that cause inflammation, pain, and fever, and is used to reduce pain, inflammation, and stiffness caused by certain forms of arthritis; to manage acute pain in adults; to treat migraines; and to treat menstrual pain.
Be sure to tell your doctor of any allergies you have whether it is to medication or food, preservatives, or dyes. Tell your doctor immediately if you are, or become pregnant, or are breastfeeding. Also tell your doctor of any other medications you are taking, including vitamins and supplements, and any medical conditions you may have.
It is very important that you take this medicine exactly as your doctor tells you to. If you miss a dose of this medicine, take it as soon as you remember, unless it is almost time for your next dose. Do NOT double doses.
If you experience any of the following, stop taking Vioxx and contact your doctor immediately: 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.
VIOXX (rofecoxib) is described chemically as 4-[4-(methylsulfonyl)phenyl]-3-phenyl-2(5H)-furanone. Rofecoxib is a white to off-white to light yellow powder. It is sparingly soluble in acetone, slightly soluble in methanol and isopropyl acetate, very slightly soluble in ethanol, practically insoluble in octanol, and insoluble in water. The empirical formula for rofecoxib is C17H14O4S, and the molecular weight is 314.36. Each tablet of VIOXX for oral administration contains either 12.5 mg, 25 mg, or 50 mg of rofecoxib and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, and yellow ferric oxide. The 50 mg tablets also contain red ferric oxide. Each 5 mL of the oral suspension contains either 12.5 or 25 mg of rofecoxib and the following inactive ingredients: citric acid (monohydrate), sodium citrate (dihydrate), sorbitol solution, strawberry flavor, xanthan gum, and purified water. Added as preservatives are sodium methylparaben 0.13% and sodium propylparaben 0.02%.
Vioxx has the following structural formula: