Rofecoxib (patient information)

IMPORTANT WARNING:

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. Rofecoxib is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children. For more information visit the FDA website at: http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#vioxx, http://www.fda.gov/cder/drug/infopage/vioxx/PHA_vioxx.htm, http://www.fda.gov/bbs/topics/news/2004/NEW01122.html and http://www.fda.gov/cder/drug/infopage/vioxx/vioxxQA.htm.

Why is this medication prescribed

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.

How should this medicine be used

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.

Shake the liquid well before each use to mix the medication evenly.

Before taking rofecoxib, carefully read the manufacturer's information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking rofecoxib:

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.

What special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Mild 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

Severe side effects

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

Rofecoxib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests to check your body's response to rofecoxib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

Vioxx®