VIOXX

Indications:

Merck & Co., Inc. announced a voluntary withdrawal of rofecoxib (Vioxx) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on rofecoxib.

VIOXX,Rofecoxib, is used to relieve the pain, tenderness, inflammation (swelling), and stiffness caused by arthritis and to treat painful menstrual periods and pain from other causes. Rofecoxib is in a class of nonsteroidal anti-inflammatory medications (NSAIDs) called COX-2 inhibitors. It works by stopping the body's production of a substance that causes pain and inflammation. COX-2 inhibitors may cause less stomach bleeding and ulcers than similar medications.

Usage:

Rofecoxib comes as a tablet and a suspension (liquid) to take by mouth. It is usually taken once a day with or without food. To help you remember to take rofecoxib, take it around the same time every day. Follow the directions on the prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rofecoxib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

special precautions:

• tell your doctor and pharmacist if you are allergic to rofecoxib, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), or any other medications.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: amitriptyline (Elavil); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); anticoagulants ('blood thinners') such as warfarin (Coumadin); aspirin; diuretics ('water pills'); lithium (Eskalith, Lithobid); methotrexate (Rheumatrex); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); rifampin (Rifadin, Rimactane); tacrine (Cognex); theophylline (Theobid, Theo-Dur); and zileuton (Zyflo). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you smoke or drink large amounts of alcohol and if you have or have ever had liver, kidney, or heart disease; heart failure; high blood pressure; asthma; or any stomach problems, including ulcers or bleeding.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking rofecoxib, call your doctor.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking rofecoxib.

side effects:

Rofecoxib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• upset stomach

• stomach pain

• weakness

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• black and tarry stools

• red blood in stools

• bloody vomit

• vomiting material that looks like coffee grounds

• excessive tiredness

• unusual bleeding or bruising

• itching

• lack of energy

• loss of appetite

• pain in the upper right part of the stomach

• yellowing of the skin or eyes

• flu-like symptoms

• rash

• pale skin

• unexplained weight gain

• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs

• hoarseness

• difficulty swallowing or breathing

• chest pain