About Vioxx

Vioxx is commonly prescribed as a treatment for pain and inflammation associated with osteoarthritis, and other acute pain unrelated to arthritic conditions. Individuals with dysmenorrhea (painful menstruation) may also find some relief from this medication. Vioxx is also sometimes prescribed for short-term pain relief after surgery.

Vioxx may also be given to patients with familial adenomatous polyposis (FAP) to reduce the numbers of colorectal polyps these individuals develop. It has not been demonstrated that Vioxx reduces their increased risk for colorectal cancer.

Vioxx belongs to a new group of non-steroidal anti-inflammatory drugs (NSAIDs) that target the Cox-2 enzyme. Previous NSAIDs, like Naprosyn or Motrin, can also interfere with the COX-1 enzyme associated with protecting the stomach lining. However, long term use of Vioxx may show a similar side effect profile (GI irritation and bleeding) to other related medications.

Vioxx is only available by prescription.

Vioxx Side Effects

Though Vioxx side effects are rarely serious enough for patients to discontinue use, some may require medical attention. Contact your doctor if you experience any of the following while taking Vioxx.

Common Vioxx side effects: Cold-like symptoms (fever, sore throat, sneezing, cough), skin rash, swelling in the extremities.

Less common Vioxx side effects: Burning sensation in chest or stomach, chest congestion, diarrhea, decreased appetite, difficulty sleeping, dizziness, flu-like symptoms (muscle aches, weakness, nausea, chills), high blood pressure, stomach tenderness, indigestion, back pain, or runny nose.

Rare Vioxx side effects: Anxiety, susceptibility to infection, constipation, breathing problems, breast problems, eye infection, cataract, dermatitis, diabetes, difficult urination, sweating, numb or tingling fingers or toes, ear infection, fungal infection, hepatitis, inflamed digestive tract or bladder, kidney stones, skin sensitivity or increased reaction to sunlight, tendonitis, hair loss, laryngitis, menstrual difficulties, herniated stomach, migraine, hypercholesterolemia, hyperglycemia, leg cramps, or nosebleeds.

Cautions: Certain conditions are incompatible with Vioxx treatment, or indicate that treatment should proceed with care. Advise your doctor of any of the following reactions.

• Allergic reactions to Vioxx mean that you should end treatment immediately. Allergies to Sulfonamides (sulfadiazine, sulfisoxazole, Gantanol, or Thiosulfil), other NSAIDs, or Aspirin also indicate that a person should not take Vioxx.
• Anemia - This medication may trigger this condition in rare cases, and should be used cautiously in individuals with a prior history of this iron deficiency. Do not take supplemental iron unless your doctor has diagnosed you with anemia and directly advised it.
• Asthma - Vioxx could trigger an attack, make sure that your doctor closely monitors any adverse reaction. Asthmatics with a sensitivity to Aspirin are at the highest risk for an allergic reaction to Vioxx.
• Dehydration - This problem should be corrected before beginning treatment with Vioxx, as it increases the risk of kidney damage.
• Diabetics - Consult with your physician before taking Vioxx, as you may be especially vulnerable to side effects.
• Heart problems - Long-term Vioxx treatment may cause renal toxicity and decreased blood flow to the heart. Patients with pre-existing heart conditions, liver problems, and those taking diuretics or ACE-inhibitors are most likely to be affected. High blood pressure is also a possible side effect of this medication. Normal function is usually restored when the patient stops taking Vioxx. This medication has been associated with a higher risk of heart attack and chest pain than comparable drugs like Naprosyn (naproxen).
• Kidney or liver impairment - Vioxx could aggravate or trigger these conditions. If you have a history of kidney or liver problems, use Vioxx with caution. Kidney damage may result from long-term use, always drink extra water with your treatment. Liver problems may be indicated by yellowing skin, pain to the right of your stomach, itchy skin, nausea, drowsiness, or other flu-like symptoms. Stop taking Vioxx and contact your doctor immediately if these conditions develop. Do not consume alcohol during the time of treatment with this medication if you have any history of liver problems.
• Pregnancy - COX II inhibitors should not be taken in the last 3 months of pregnancy, and have not been studied for safety earlier in pregnancy.
• Ulcer or Gastrointestinal Bleeding - Any history of these conditions is an indication for extreme caution in the use of any NSAID, including the COX II inhibitors. These medications may cause or aggravate deterioration and bleeding in the GI tract. Active ulcers are a contraindication for treatment.
• Water retention - Vioxx can aggravate any problems related to fluid retention such as heart failure, high blood pressure, or swelling.

Warning signs: Stop taking Vioxx and contact your doctor immediately if you notice severe stomach cramps, swelling in your face or extremities, skin rash, black stools, vomiting bloody or black material, or sudden weight gain.

Seek emergency treatment if any of the following symptoms occur while taking Vioxx, as they are signs of anaphylaxis, a severe allergic reaction most common in asthmatic patients with aspirin sensitivity: severe breathing difficulties (breathing too fast, shortness of breath, irregular breathing or fainting), hive-like rash, fast or irregular heartbeat, swelling around eyes. Have someone drive you to the hospital or call for an ambulance, it is extremely dangerous to drive in this condition. If you must wait for an ambulance, lie down with your feet elevated and be sure to keep warm. If this rare reaction occurs, or you have had a similar reaction to aspirin or a sulfonamide, you will have to stop taking Vioxx.

Vioxx Interactions

Certain drugs react with Vioxx. Your doctor may adjust the dosage of one of the medications, or may indicate that they should not be taken together. Always consult your doctor or pharmacist about potential drug interactions.

• ACE (Angiotensin Converting Enzyme) inhibitors such as Capoten (captopril), Prinivil (lisinopril), or Vasotec (Enalapril) - Vioxx may reduce the effectiveness of these blood pressure medications.
• Alcohol - Do not drink alcoholic beverages while using Vioxx, as it puts you at risk for stomach problems and liver degeneration.
• Aspirin - Taking Aspirin with Vioxx may increase the risk of gastrointestinal bleeding. If you have ever had an allergic reaction to Aspirin, you should not take Vioxx.
• Cordarone (amiodarone) - Lower doses of Vioxx recommended.
• Corticosteroids - mixing these drugs with Vioxx increses the risk of gastrointestinal bleeding.
• Coumadin (warfarin)
• Diflucan (fluconazole) - May increase risk of side effects.
• Fosamax (alendronate) - The effectiveness of this osteoporosis medication may be decreased by Vioxx.
• Lasix (furosemide)
• Lithium (Eskalith, Lithane, etc.) - May prevent Vioxx from clearing from the blood and increase side effects
• Methotrexate (Amethopterin) - This medication may build up to toxic levels with combined use.
• NSAIDs of any other type, such as Naprosyn or Motrin may increase risk of side effects when mixed with Vioxx, particularly GI bleeding or stomach irritation. If you have ever had an allergic reaction to one of these drugs, you should not take Vioxx.
• Protease inhibitors like Norvir (ritonavir) may need to be accompanied by lower doses of Vioxx.
• Rhythmol (propafenone) - Dosing adjustment may be necessary.
• SSRIs like Prozac (fluoxetine) and Zoloft (sertraline) may reduce clearance of COX II inhibitors and increase side effects. Lower doses are recommended if you are currently being treated with one of these medications.
• Thiazide (hydrochlorothiazide, Dyazide, Corzide) - Vioxx may interfere with these diuretics and increase the risk of heart problems.
• Tobacco - May increase the risk of side effects.
• Toradol (ketorolac) - Do not take this medication while taking Vioxx.

Vioxx Dosages

Vioxx is commonly prescribed in the following doses. Follow your doctor's advice if he suggest a different dosage, always use the minimum effective dose.

• Osteoarthritis - 12.5 mg once a day, up to a maximum of 25 mg once daily.
• Acute or Menstrual Pain - 50 mg once a day, for up to 5 days
• Kidney Impairment: This medication is not recommended in acute kidney disease or failure
• Liver Impairment: Patients with liver disease or impairment may be prescribed half the regular dose. This medication is not recommended in acute liver disease.

Vioxx is available in the following forms and strengths:

• 12.5 mg, off-white tablet
• 25 mg, yellow tablet
• 50 mg, orange tablet
• 12.5 mg/5 mL oral suspension, white to light yellow, strawberry flavored
• 25 mg/5 mL oral suspension, white to light yellow, strawberry flavored

Vioxx Directions

Vioxx should be taken according to your doctor's instructions about dosage and frequency. If you miss a dose, take it immediately if you remember soon after missing it. If it's close to the time when you would ordinarily take another dose, wait until your scheduled time to take the next dose. Do not take a double dose of Vioxx.

Store Vioxx away from direct light and heat. Store in a dry location, avoid storing it in the bathroom, near sinks, or other areas where it may become damp. Do not use after the expiration date.

The oral suspension form should not be allowed to freeze, and should be shaken before use.

Keep Vioxx away from children; both when storing it, and when discarding any unused medication.

Vioxx and Pregnancy

Vioxx has been shown to cause an increase of birth defects and difficulties carrying a child to term in animals. Vioxx may also pass to a child during breastfeeding, and may cause adverse reactions. Vioxx is not recommended for pregnant or nursing women.

Vioxx treatment does not appear to affect fertility or the health of future children after treatment.

Vioxx and Children

Vioxx has not been shown to be safe or effective in children under 18.

Vioxx and Seniors

Vioxx does not appear to behave very differently in adults over 65 than in the rest of the adult population, though there is a slight increase in unwanted side effects. Spontaneous gastrointestinal bleeding has been responsible for most of the increase in adverse reactions in elderly and debilitated populations. Seniors with a history of heart problems, water retention, ulcers, or gastrointestinal bleeding should be treated with caution, and for as short a time as possible.

Vioxx is a trademark of Merck & Co. Inc.