Serious skin reactions (eg, toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme) have been reported in patients receiving valdecoxib, some resulting in death. Patients appear to be at higher risk for these events during the first 2 weeks of treatment, but these may occur at any time. Valdecoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Analgesic
Pharmacologic Class: Cyclooxygenase-2 Inhibitor
Valdecoxib is a non-steroidal anti-inflammatory drug. Nonsteroidal anti-inflammatory drugs (also called NSAIDs) are used to relieve some symptoms caused by arthritis (rheumatism), such as inflammation, swelling, stiffness, and joint pain. However, valdecoxib does not cure arthritis and will help you only as long as you continue to take it. It may also be used to treat pain associated with menstrual periods.
valdecoxib was available only with your doctor's prescription.
Valdecoxib was voluntarily withdrawn from the U.S. market on April 7, 2005 due to safety concerns of increased risk of serious heart problems and skin reactions .
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For valdecoxib, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to valdecoxib or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies on valdecoxib have been done only in adult patients, and there is no specific information comparing use of valdecoxib in children with use in other age groups.
valdecoxib has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using valdecoxib with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of valdecoxib. Make sure you tell your doctor if you have any other medical problems, especially:
The dose of valdecoxib will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of valdecoxib. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
The following section is for information only, since the drug is no longer available.
If you miss a dose of valdecoxib, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
If you will be taking valdecoxib for a long time, it is very important that your doctor check you at regular visits.
Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with valdecoxib. Therefore, do not regularly drink alcoholic beverages while taking valdecoxib, unless otherwise directed by your doctor.
Serious side effects can occur during treatment with valdecoxib. Sometimes serious side effects can occur without any warning. However, possible warning signs often occur, including swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, sticky stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; and/or skin rash. Stop taking valdecoxib and check with your doctor immediately if you notice any of these warning signs.
Serious skin reactions can occur during treatment with valdecoxib. Check with your doctor right away if you have any of the following symptoms while taking valdecoxib: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness.
Check with your doctor immediately if fever, drowsiness, itching of the skin, tiredness, nausea, or stomach pain occurs; these effects may be the first signs of liver toxicity.
Valdecoxib may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin, other nonsteroidal anti-inflammatory drugs, or sulfonamide-type drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once. Do not try to drive yourself. Call an ambulance, lie down, cover yourself to keep warm, and prop your feet higher than your head. Stay in that position until help arrives.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Less common
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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