Drug: Vioxx

Generic Name: rofecoxib (oral) (row feh COCK sib)
Brand Name: Vioxx

What is rofecoxib?

Rofecoxib (Vioxx) was withdrawn from the U.S. market in 2004.

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 is the most important information I should know about rofecoxib?

Rofecoxib (Vioxx) was withdrawn from the U.S. market in 2004.

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 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.

Rofecoxib side effects

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.

See also: Side effects (in more detail)

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.

Source: http://www.drugs.com/

Note: This page contains side effects data for the generic drug rofecoxib. It is possible that some of the dosage forms included below may not apply to the brand name Vioxx.

It is possible that some side effects of Vioxx may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to rofecoxib: oral suspension, oral tablet

As well as its needed effects, rofecoxib (the active ingredient contained in Vioxx) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking rofecoxib, check with your doctor or nurse as soon as possible:

More common
  • Congestion in chest
  • cough
  • fever
  • sneezing
  • sore throat
Less common or rare
  • Bloody or black, tarry stools
  • burning feeling in chest or stomach
  • chills
  • hives
  • loss of appetite
  • muscle aches and pain
  • prolonged or severe vomiting
  • shortness of breath
  • skin rash
  • tenderness in the stomach area
  • unusual weight gain
  • vomiting of blood or material that looks like coffee grounds

Some rofecoxib side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Back pain
  • diarrhea
  • dizziness
  • headache
  • heartburn
  • loss of energy or weakness
  • nausea
  • stuffy or runny nose
  • swelling of legs and feet
Less common or rare
  • Blurred vision
  • constipation

For Healthcare Professionals

Applies to rofecoxib: oral suspension, oral tablet

Gastrointestinal

Serious gastrointestinal toxicity such as bleeding, ulceration, and perforation of the stomach, small or large intestine, can occur at any time, with or without symptoms, in patients treated with nonsteroidal anti-inflammatories. The incidence of upper GI adverse events (perforations, ulcers, and bleed) was shown to be significantly lower (1.3% vs 1.8%) in patients with osteoarthritis receiving rofecoxib (the active ingredient contained in Vioxx) 12.5, 25, or 50 mg/day than in those receiving ibuprofen, diclofenac, or nabumetone. Risk factors for NSAID-induced GI bleeding include a prior history of peptic ulcer disease or gastrointestinal bleeding, treatment with oral corticosteroids, anticoagulation therapy, smoking, alcoholism, older age, poor general health status, and longer duration of NSAID therapy.

Rofecoxib (50 mg a day) has also been shown to have a lower incidence of serious upper gastrointestinal adverse events such as major bleeding, perforation, and obstruction compared to naproxen (1000 mg a day). The reduction in risk was about 50% in cumulative rates for rofecoxib (0.52%) compared to naproxen (1.22%) in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study.[Ref]

Gastrointestinal side effects have included diarrhea, dyspepsia, epigastric discomfort, heartburn, and nausea. These were the most frequently reported gastrointestinal adverse events occurring in greater than 2% of patients. Other reported adverse events occurring in less than 2% of patients studied have included acid reflux, aphthous stomatitis, constipation, dental caries, dental pain, digestive gas symptoms, dry mouth, duodenal disorder, dysgeusia, esophagitis, flatulence, gastric disorder, gastritis, gastroenteritis, hematochezia, hemorrhoids, infectious gastroenteritis, oral infection, oral lesion, oral ulcer, vomiting, colitis, colonic malignant neoplasm, cholecystitis, duodenal ulcer, gastrointestinal bleeding, intestinal obstruction, and pancreatitis.

Rofecoxib 50 mg/day has been associated with a higher incidence of gastrointestinal symptoms (abdominal pain, epigastric pain, heartburn, nausea and vomiting) than that seen with either 12.5 or 25 mg/day dosage.[Ref]

General

General side effects have included asthenia, fatigue, dizziness, influenza-like disease, lower extremity edema, sinusitis and upper respiratory infection. Other general side effects have included abscess, chest pain, chills, contusion, cyst, diaphragmatic hernia, fever, fluid retention, flushing, fungal infection, infection, laceration, pain, pelvic pain, peripheral edema, postoperative pain, syncope, trauma, upper extremity edema, viral syndrome, cerumen impaction, epistaxis, dry throat, otic pain, otitis, otitis media, pharyngitis, tinnitus, and tonsillitis.[Ref]

Hepatic

Hepatic side effects have included borderline elevations of one or more liver tests that may occur in up to 15% of patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). In addition, elevations of ALT or AST greater than three times normal have been reported in 1% of patients in clinical trials with NSAIDs. Patients with signs and/or symptoms of liver disease or with abnormal liver tests should be monitored carefully while on rofecoxib (the active ingredient contained in Vioxx) for evidence of worsening disease. If signs and symptoms consistent with liver disease develop, rofecoxib should be discontinued. Use of rofecoxib is not recommended in patients with severe hepatic insufficiency.[Ref]

In controlled clinical trials of rofecoxib, the incidence of borderline elevation of liver tests was comparable to the incidence observed with ibuprofen and lower than that observed with diclofenac. In placebo controlled trials, approximately 0.5% of patients taking rofecoxib and 0.1% of patients taking placebo had noticeable elevations of ALT or AST.[Ref]

Cardiovascular

Cardiovascular side effects have included hypertension in greater than 2% of patients. Other cardiovascular side effects have included angina pectoris, atrial fibrillation, bradycardia, hematoma, irregular heart beat, palpitation, premature ventricular contraction, tachycardia, cerebrovascular accident, congestive heart failure, deep venous thrombosis, myocardial infarction, pulmonary edema, pulmonary embolism, transient ischemic attack, unstable angina and venous insufficiency.[Ref]

The cumulative rate of serious cardiovascular thromboembolic adverse events (heart attacks, angina pectoris, and peripheral vascular events) was reported to occur in a higher percentage of patients receiving rofecoxib (1.8%) compared to patients receiving naproxen (0.6%) in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study. The relationship of the cardiovascular findings to the use of rofecoxib is not known.

Patients being treated for rheumatoid arthritis with rofecoxib at a dose of 25 mg a day have been reported to have a higher incidence of hypertension compared to patients treated with naproxen at a dose of 1000 mg a day.

Lower extremity edema and hypertension have been reported to occur less often with the 12.5 and 25 mg/day dosage than with the 50 mg/day dosage.[Ref]

Ocular

Ocular side effects have included blurred vision, ocular injection and conjunctivitis.[Ref]

Metabolic

Metabolic side effects have included appetite change, hypercholesterolemia, and weight gain. Hyponatremia has been reported in less than 1% of patients.[Ref]

Renal

In two separate studies, a similar reduction in glomerular filtration rate to nonselective nonsteroidal anti-inflammatory drugs was observed.

Sudden reduction in urine output and rise in serum creatinine levels were observed in a 65-year-old woman, with a history of mild renal failure (Clcr = 57 mL/min), hyperuricemia, mitral valve regurgitation and heart failure, after receiving a single dose of rofecoxib (the active ingredient contained in Vioxx) 25 mg because of lower back pain. Over the course of her hospital stay, her renal laboratory parameters slowly returned to her baseline levels.

Acute interstitial nephritis has been reported in a 63-year-old man diagnosed with third-degree burns, on 70% of body surface area, that had been receiving for 3 weeks rofecoxib 25 mg daily for arthritis. Patient underwent one hemodialysis treatment. Creatinine and potassium levels returned to baseline levels a month later.[Ref]

Renal side effects have included a decrease in glomerular filtration rate. Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Acute renal failure after a single dose of rofecoxib has been reported. Interstitial nephritis has been diagnosed in a patient 3 weeks after the start of treatment with rofecoxib.[Ref]

Immunologic

Immunologic, nonspecific, side effects have included allergic reactions and insect bite reactions in less than 2% of patients receiving rofecoxib (the active ingredient contained in Vioxx) [Ref]

Dermatologic

Cases of neutrophilic dermatosis have been reported to occur within one to two weeks of initiation of rofecoxib (the active ingredient contained in Vioxx) treatment for joint pains. Patients presented with multiple subcutaneous nodules over both legs, anterior and posterior areas, and areas of ulceration. The patient's leg lesions disappeared after discontinuation of rofecoxib.

A 46-year-old woman who had previously developed psoriasis after exposure to a nonselective NSAID developed a severe case of psoriasis 5 days after she started taking rofecoxib for neck strain. It took several months for symptoms to abate.[Ref]

Dermatologic side effects have included alopecia, atopic dermatitis, basal cell carcinoma, contact dermatitis, herpes simplex, herpes zoster, nail unit disorder, perspiration, pruritus, rash, skin erythema, urticaria, and xerosis. Acute onset of neutrophilic dermatosis has been reported shortly after initiation of rofecoxib therapy. A severe case of psoriasis has been reported to have developed 5 days after the start of treatment with rofecoxib.

Pseudoporphyria has been reported in a 60-year-old woman 2 weeks after the start of rofecoxib treatment for pain control. The skin lesions cleared within 1 month after discontinuation of therapy.[Ref]

Nervous system

Nervous system side effects have included headache, hypesthesia, insomnia, median nerve neuropathy, migraine, muscular spasm, paresthesia, sciatica, somnolence, and vertigo. In the postmarketing phase of rofecoxib (the active ingredient contained in Vioxx) aseptic meningitis has been reported to the Spontaneous Reporting System of the FDA.[Ref]

Psychiatric

Psychiatric side effects have included anxiety, depression, and decreased mental acuity.[Ref]

Respiratory

Respiratory side effects have included bronchitis, asthma, cough, dyspnea, pneumonia, pulmonary congestion, laryngitis, pharyngitis, allergic rhinitis, and nasal congestion.[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain, arm pain, arthralgia, bursitis, cartilage trauma, joint swelling, muscle cramps, muscle weakness, musculoskeletal pain, musculoskeletal stiffness, myalgia, osteoarthritis, tendonitis, traumatic arthropathy, and wrist fracture.[Ref]

Genitourinary

Breast malignant neoplasm, prostate malignant neoplasm and urolithiasis have been reported in less than 0.1% of patients.[Ref]

Genitourinary side effects have included urinary tract infections, cystitis, dysuria, menopausal symptoms, menstrual disorder, nocturia, urinary retention, vaginitis, breast mass, and urolithiasis.[Ref]

Hematologic

Hematologic side effects have included reports of lymphoma in less than 0.1% of patients.[Ref]

Source: http://www.drugs.com/

Rofecoxib Pregnancy Warnings

Merck pharmaceuticals encourages healthcare providers to report any prenatal exposure to rofecoxib by calling the Pregnancy Registry at (800)-986-8999. The registry has been created to monitor the pregnancy outcomes of women exposed to rofecoxib while pregnant.

Rofecoxib has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. Data from human pregnancy studies are not available. Rofecoxib should only be given during pregnancy when benefit outweighs risk. The manufacturer recommends that rofecoxib be avoided in late pregnancy (third trimester) due to the risk of premature closure of the ductus arteriosus.

Rofecoxib Breastfeeding Warnings

There is no data on the excretion of rofecoxib into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Source: http://www.drugs.com/

Health Services in Toronto

Drug Database Online

Welcome to WebHealthNetwork an online drug guide and dictionary, here you can get drug information and definitaions for most popular pharmaceutical and medicinal drugs, and specifically Vioxx. Find what medications you are taking today.