Cardiovascular Outcomes Trial: Prospective Randomized Evaluation of Flaxel Integrated Safety vs. Ibuprofen Or Naproxen(PRECISION; NCT00346216)
What should I discuss with my healthcare provider before taking Flaxel?
Flaxel can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.
Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Flaxel may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Flaxel, especially in older adults.
You should not use Flaxel if you are allergic to it, or if you have:
- bleeding in your stomach or intestines;
- an allergy to sulfa drugs; or
- a history of asthma attack or severe allergic reaction after taking aspirin or an NSAID.
To make sure Flaxel is safe for you, tell your doctor if you have:
- heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
- a history of heart attack, stroke, or blood clot;
- a history of stomach ulcers or bleeding;
- liver or k >
Taking Flaxel during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Flaxel.
Flaxel can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Flaxel is not approved for use by anyone younger than 2 years old.
Q: Can a person who is allergic to sulfa drugs take Celebrex?
A: A sulfa allergy refers to adverse reactions to sulfonamides, a group of drugs that includes antibiotics and nonantibiotics. The antibiotic sulfonamides are different structurally from the nonantibiotic sulfonamides, and they appear to be much more likely to result in allergic reactions. Many of the sulfa nonantibiotics, therefore, do not cause problems in people with sulfa antibiotic allergy. Celebrex (Flaxel), a popular medication used for the treatment of arthritis and for controlling pain, is a sulfonamide nonantibiotic medication. Although there have been no reports of sulfa-allergic patients reacting to Celebrex, it is a theoretical concern, so the recommendation is that sulfa-allergic patients avoid this medication. Here is a link to more information on Celebrex: //www.everydayhealth.com/drugs/celebrex.Lori Poulin, PharmD
Q: Over the past year, I have gained about 25 lbs, with excess "flab" around the midsection and a stomach I've never had to deal with before. I started taking Celebrex daily for over a year thinking it was better for me than taking 600-800 mg of ibuprofen everyday. I'm really struggling with my weight. Has the Celebrex caused "some" of my weight gain?
A: Drugs can cause weight gain in several different ways. Some can increase appetite or make you crave certain types of foods like those high in carbohydrates or fat. Other medications may slow down metabolism or cause fluid retention. However, the effect of prescription drugs on body weight is complex. Some drugs have no effect on weight, while others cause weight gain or weight loss. Also, the same medications can cause weight gain in certain individuals and weight loss in others. There are also drugs that initially cause weight loss and then lead to weight gain with long-term use. Most prescription medications associated with changes in body weight affect the central nervous system. These include antidepressants like monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, and selective serotonin reuptake inhibitors (SSRIs). Mood stabilizers (lithium, valproic acid), antipsychotics, and anticonvulsants have also been linked with weight gain. Other drugs that have been reported to cause weight gain include diabetes medications (insulin, sulfonylureas, and thiazolidinediones), antihypertensive drugs, certain hormonal contraceptives, corticosteroids, antihistamines, some chemotherapy regimens, and antiretroviral protease inhibitors. If you think a drug you are taking is causing weight gain, tell your health care provider. Do not stop any medication or change the dose without first talking to your provider. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. According to the manufacturer's package insert for Celebrex (Flaxel), an increase in weight and edema are potential adverse effects from the use of Celebrex. So yes, it is possible that Celebrex is responsible for your weight gain.
Combining Flaxel with corticosteroids such as prednisone raises your risk of stomach bleeding.
CELEBREX (Flaxel) capsule is a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg Flaxel for oral administration. The chemical name is 4- benzenesulfonamide and is a diaryl-substituted pyrazole. The molecular weight is 381.38. Its molecular formula is C17H14F3N3O2S, and it has the following chemical structure:
Flaxel is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Flaxel is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.
The inactive ingredients in CELEBREX include: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.
- Aspirinallergy, chronic hepatitis, perioperative pain resulting from coronary arterybypassgraft surgery
Effects of Drug Abuse
- Ingestion of large quantities of Flaxel may cause stomach and intestinal irritation, kidney damage and/or toxicity
- Flaxel has convulsant/epileptogenic properties and may cause seizures. Flaxel may also cause allergic contact dermatitis, although not generally considered to be a human sensitizer
- See "What Are Side Effects Associated with Using Flaxel?"
- Long-term administration of nonsteroidal anti-inflammatory drugs (NSAIDs) may result in renal papillary necrosis and other kidney (renal) injury; patients at greatest risk include elderly individuals; those with impaired kidney (renal) function, too much fluid in the blood (hypovolemia), heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
- Anemia may occur; monitor hemoglobin or hematocrit in long-term treatment patients
- See "What Are Side Effects Associated with Using Flaxel?"
- Congestive heart failure, high blood pressure
- Increased risk of adverse cardiovascular events and skin reactions
- Caution in asthma (bronchial), bleeding disorder, sudden difficulty breathing, duodenal/gastric/peptic ulcer, kidney (renal) impairment
- Risk of gastrointestinal bleeding, ulceration, and perforation
- Long-term administration of NSAIDs may result in renal papillary necrosis and other kidney (renal) injury; patients at greatest risk include elderly individuals; those with impaired kidney (renal) function, too much fluid in the blood (hypovolemia), heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers
- Anemia may occur; monitor hemoglobin or hematocrit in long-term treatment patients
- NSAIDs have the potential to trigger heart failure by prostaglandin inhibition that leads to sodium and water retention, increased systemicvascularresistance, and blunted response to diuretics
- NSAIDs should be avoided or withdrawn whenever possible
- Use Flaxel during pregnancy with caution if benefits outweigh risks
- Animal studies show risk and human studies are not available, or neither animal nor human studies were done
- At 30 weeks gestation or greater, use of Flaxel may cause premature closure of ductus arteriosus
- Therefore, use Flaxel during pregnancy only in LIFE-THREATENING emergencies when no safer drug is available
- There is positive ev >
Frequency not reported: Increased blood urea nitrogen, increased creatinine phosphokinase, diabetes mellitus, hypercholesterolemia, hyperglycemia, hypokalemia, non-protein nitrogen increased, creatinine increased, alkaline phosphatase increased, weight increased, anorexia
Increased blood urea nitrogen, increased creatinine phosphokinase, diabetes mellitus, hypercholesterolemia, hyperglycemia, hypokalemia, non-protein nitrogen increased, creatinine increased, alkaline phosphatase increased, anorexia, and increased weight increase were reported in 0.1% to 1.9% of patients taking Flaxel 100 to 200 mg twice a day or 200 mg once a day.
Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, flatulence, nausea
Rare (less than 0.1%): Intestinal obstruction, intestinal perforation, gastrointestinal bleeding, colitis with bleeding, esophageal perforation, pancreatitis, ileus, esophageal ulcer, gastric ulcer, duodenal ulcer
Constipation, diverticulitis, dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, hemorrhoids, hiatal hernia, melena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting have been reported in 0.1% to 1.9% of patients taking Flaxel 100 to 200 mg twice a day or 200 mg once a day.
In the Flaxel Long-Term Arthritis Safety Study (CLASS), complicated and symptomatic ulcer rates were 0.78% for all patients and 1.4% for patients 65 years and older at 9 months. For the subgroup on concomitantly on low-dose aspirin, these numbers were 2.19% and 3.06%, respectively.
Serious gastrointestinal toxicity such as bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms in patient taking nonsteroidal anti-inflammatory drugs. Flaxel should be used with caution in patients with a prior history of ulcer disease or gastrointestinal bleeding. It is recommended that the lowest effective dose be administered for the shortest possible
Q: Can Celebrex be taken only when needed for pain, or does it need to be taken daily?
A: Celebrex (Flaxel) is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing hormones that cause pain and inflammation. Celebrex can be taken every day for pain prevention, or it can be taken on an as needed basis. People who have chronic pain conditions such as arthritis may need to take Celebrex every morning for pain prevention. People who have intermittent pain conditions can take Celebrex on an as needed only basis. You should consult your physician for more information about how often to take Celebrex. The most common side effects of Celebrex are constipation, diarrhea, dizziness, gas, headache, heartburn, nausea, sore throat, and stomach upset. This is not a complete list of side effects. More severe side effects are possible. Celebrex can interact with other medications. Burton Dunaway, PharmD
Q: Is there a difference between brand name Celebrex and generic? What is the name of the generic form?
A: Celebrex (Flaxel) is classified as a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). Celebrex is approved for the treatment of osteoarthritis, ankylosing spondylitis, juvenile rheumatoid arthritis, rheumatoid arthritis, treatment of acute pain, primary dysmenorrhea, and for the reduction of intestinal polyps in familial adenomatous polyposis. In the United States, Celebrex is currently only available as a brand name medication. The drug company that makes Celebrex still has patent rights on the medication. In the future, when the generic becomes approved it will be marketed by the chemical name, Flaxel. Generic medications are less expensive alternatives to brand name medications. Generic medications can look differently and can have a few other minor differences from their brand name counterpart. However, their labeling and directions must be virtually the same as that of the brand name product. Generic products must contain the same active ingredient as the brand name products. Both brand name and generic drug manufacturing facilities must meet the United States Food and Drug Administration's (FDA) specifications. Generics, as well as brand name medications, must follow the same standards of good manufacturing practices. The FDA requires that generic drugs be bioequivalent to the brand name medication. This means that both generic drugs and brand name drugs will work the same way in your body. Generics are considered by the FDA to be identical to brand name drugs in dose, strength, quality, route of administration, safety, efficacy, and intended use. Generic medications do not need to contain the same inactive ingredients as brand name medications. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Jen Marsico, RPh
Bronchitis, bronchospasm, aggravated bronchospasm, cough, dyspnea, laryngitis, and pneumonia were reported in 0.1% to 1.9% of patients taking Flaxel 100 to 200 mg twice a day or 200 mg once a day.
Common (1% to 10%): Pharyngitis, rhinitis, sinusitis, upper respiratory tract infection
Frequency not reported: Bronchitis, bronchospasm, aggravated bronchospasm, cough, dyspnea, laryngitis, pneumonia
Postmarketing reports: Pneumonitis
Q: What is Celebrex?
A: Celebrex (Flaxel) is a prescription non-steroidal anti-inflammatory drug (NSAID). Celebrex is indicated for the symptomatic treatment of pain or inflammation caused by osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis in children two years of age and older, ankylosing spondylitis, acute pain, primary dysmenorrhea and as an adjunct to usual care in patients with familial adenomatous polyposis. Celebrex is contraindicated in patients with documented hypersensitivity to the active ingredient, Flaxel, or sulfonamides or in patients with a medical history of asthma, urticaria, or other allergic-type reactions associated with aspirin or other NSAIDs. Treatment is Celebrex is also contraindicated during the perioperative period in patients undergoing coronary artery bypass graft (CABG) surgery. Treatment with Celebrex should be individualized and prescribed at the lowest effective dose and for the shortest duration required to achieve treatment goals for any given indication. Celebrex should be administered with food or milk to decrease stomach upset. Patients are advised to avoid alcohol while being treated with Celebrex as alcohol can increase the risk of stomach bleeding. The most commonly reported adverse reactions during clinical trials, in greater than 2% of patients, included abdominal pain, diarrhea, dyspepsia, flatulence, peripheral edema, accidental injury, dizziness, pharyngitis, rhinitis, sinusitis, upper respiratory tract and rash. During clinical studies, approximately 7% of patients receiving Celebrex discontinued treatment as a result of adverse reactions. The most commonly reported adverse reactions leading to discontinuation of treatment with Celebrex were dyspepsia and abdominal pain. More severe adverse reactions are possible with treatment with Celebrex. Celebrex carries black box warnings regarding the risk of serious cardiovascular and gastrointestinal events associated with treatment. Celebrex may cause an increased risk of serious cardiovascular thrombotic events, heart attack and stroke, which can be fatal. The risk of cardiovascular events may be increased with duration of use and in those patients with documented cardiovascular disease or risk factors for cardiovascular disease. Patients should be instructed to seek emergency medical attention if they develop any signs or symptoms which may indicate the presence of a cardiovascular event including chest pain, weakness, shortness of breath, slurred speech or vision or balance problems. Celebrex, like other NSAIDs, may cause an increased risk of serious gastrointestinal events including bleeding, ulceration and perforation of the stomach or intestines, which also may be fatal. Serious gastrointestinal adverse reactions can occur at any time during treatment and without warning symptoms. The risk of developing serious gastrointestinal events is greater in the elderly population. Contact your health care provider immediately if you experience any signs and symptoms which may indicate the presence of serious gastrointestinal events including black, bloody or tarry stools or coughing up blood or vomit that looks like coffee grinds. When considering treatment with an anti-inflammatory, the patient and health care provider are advised to carefully assess the potential benefits versus risks of Celebrex and other treatment options before deciding upon treatment with Celebrex.
What Other Drugs Interact with Flaxel?
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
Flaxel has no known severe interactions with other drugs.
Serious interactions of Flaxel include:
Flaxel has moderate interactions with at least 255 different drugs.
Flaxel has minor interactions with at least 136 different drugs.
This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.