WASHINGTON, D. C. —An FDA advisory panel has voted to require the drugmaker to pay for a trial of the drug's use in treating heart failure.
The vote was based on a report published last week by theNew England Journal of Medicinethat found a small increase in the number of patients who received heart failure drugs, even for patients with normal heart rhythms.
The FDA has issued a "black box" warning that it would require companies to pay for trials of the drugs they sell to treat heart failure.
"There are no adequate or effective treatments for heart failure that patients can take," the FDA said in a statement. "We would like to see an increased incidence of serious side effects, including death, in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs)," it added.
The agency said it was reviewing the data from the FDA and other research studies of Celebrex, also known as celecoxib, and the results would help doctors determine whether celecoxib is safe and effective. The agency is also investigating whether other medications that contain celecoxib, such as aspirin and ibuprofen, can be used as a treatment for heart failure.
Celebrex is sold by the companies Celebrex, Celecoxib and Naproxen. The company that makes the drug said it is the only one to have received FDA approval for heart failure prevention.
It is used to prevent heart failure in patients who have had a heart attack or who have had a stroke. Heart failure is defined as the failure of the heart to pump blood effectively enough to make it possible for it to work properly.
Celebrex is prescribed for patients with mild-to-moderate heart failure that has not improved or is under control. Patients who have been treated for heart failure or who have had a heart attack are also referred to as heart failure patients. Those who have had a heart attack in the past 12 months are also called NYHA Class III heart failure patients.
In 2004, the FDA approved Celebrex in more than 100,000 patients with mild to moderate heart failure.
However, it was later found to be associated with serious side effects, including an increased risk of heart attack and death.
In June, the FDA issued a warning that the safety of the drug in the United States is unknown.
The panel voted 14 to 3 to recommend that drug companies pay for trials of a non-NSAID treatment for patients with heart failure.
The panel said that the data available to the FDA indicated that there may be a small increase in the number of patients who received heart failure drugs.
However, the FDA said that there may be other possible causes of the drug's increase in heart failure.
The FDA said it was not aware of any other potential causes of the drug's increased heart failure risk.
The panel voted 8 to 2 to recommend that the FDA pay for a clinical trial of an NSAID, such as Celebrex, which will examine whether Celebrex could be used safely as a treatment for heart failure.
The drug, which is marketed under the brand name Celebrex, was developed to help relieve pain and inflammation.
It was not clear whether Celebrex would cause any adverse effects to patients. The panel voted 3 to recommend that the FDA pay for a clinical trial of a drug that would assess the safety and efficacy of Celebrex in patients with heart failure.
The FDA said that the drug's safety study was the first study to evaluate the safety and efficacy of Celebrex in patients with heart failure.
It was not clear whether the trial would be approved for use by patients who had already received heart failure treatment.
The panel also did not recommend that any FDA-approved treatment for heart failure be approved for use in patients with heart failure.
The FDA is requiring manufacturers to pay for trials of Celebrex, as well as other non-NSAID heart failure treatments, such as aspirin and ibuprofen.
The FDA has requested that manufacturers provide information about the safety and efficacy of Celebrex in patients with heart failure.
U. S. Food and Drug Administration (FDA)February 7, 2008
FDA News Service
Copyright © 2006 by WJMS. All rights reserved.
This leaflet answers some common questions about Celebrex. It does not contain all of the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Celebrex against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with your medicine.You may need to read it again.
Celebrex is used to treat pain caused by conditions other than those for which it is approved to treat them. It reduces the amount of pain you get from taking pain medicine, and reduces the amount of pain you can get from taking Celebrex.
It is also used to treat pain caused by conditions other than those for which it is approved to treat them.
Celebrex works by blocking the action of a chemical messenger within your body. This messenger is called COX-1.
Celebrex is a selective COX-1 inhibitor, which means it does not stop the production of other substances in your body that cause pain.
Celebrex will not work for pain caused by conditions other than those that cause pain.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
There may be other reasons why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
Do not take Celebrex if you have a known hypersensitivity (allergy) to any of its ingredients.
It may also reduce your effectiveness of other medicines (including other painkillers).
Do not take Celebrex if you have an allergy to:
any medicine containing Celebrex
any of the ingredients listed at the end of this leaflet
any of the other ingredients listed at the end of this leaflet
Do not take Celebrex if you are pregnant.
Do not take Celebrex if you are breastfeeding.
Celebrex passes into breast milk. However, this medicine has not been shown to cause problems with milk production.
Do not use Celebrex if you are taking or have recently taken a medicine for cancer (including the painkiller omeprazole).
It is not known if Celebrex will affect pregnant women. However, the possibility of taking it in pregnancy has not been established.
Do not take Celebrex if you are taking or have recently taken a medicine for cancer including the painkiller omeprazole. It can cause serious side effects such as stomach upset, diarrhea, loss of appetite and vomiting.
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Your doctor or pharmacist will tell you what to do if you have any of the following conditions:
Tell your doctor if you are pregnant or plan to become pregnant or if you are breastfeeding.
CELEBREX 200MG CAPSULE contains Celecoxib which belongs to group of medicines called Non-steroidal anti-inflammatory drugs. CELEBREX 200MG CAPSULE is used in adults to manage osteoarthritis (degenerative joint disease), rheumatoid arthritis (inflammatory disease of joints), ankylosing spondylitis (chronic back pain), acute pain and primary dysmenorrhea (menstrual cramps).
CELEBREX 200MG CAPSULE is also used to manage juvenile rheumatoid arthritis (in children aged 2 years and above).
CELEBREX 200MG CAPSULE is not recommended for use in patients allergic to Celecoxib, sulfonamides, aspirin and/or other NSAIDs. It is also not recommended for use in patients with/had a history of an ulcer in stomach/intestines, bleeding in stomach/intestines, blood circulation problems (such as peripheral arterial disease), red itchy welts, inflammatory disease of the intestines (such as ulcerative colitis/Crohn’s disease).
The medicine is also not indicted for use in patients suffering from lung problems (such as asthma), heart diseases (such as heart failure, recent heart attack, heart block), severe liver disease (such as advanced hepatic insufficiency) and/or kidney disease (such as advanced renal insufficiency).
Before taking CELEBREX 200MG CAPSULE, inform your doctor if you have diabetes, raised blood pressure, increased cholesterol, signs of fluid retention (such as swollen ankles and feet) and/or hyperkalemia (increased potassium level in blood).
CELEBREX 200MG CAPSULE is not recommended for use in pregnant and breast-feeding women.
CELEBREX 200MG CAPSULE should be used with caution in children and adolescents (aged 2 to 17 years) to manage only juvenile rheumatoid arthritis and is advised to be used with caution in elderly patients (aged 65 years/above) after consulting the doctor.
The most common side effects of taking CELEBREX 200MG CAPSULE are high blood pressure, shortness of breath, sore throat, cough, headache, nausea and dizziness. Consult your doctor if any of these symptoms worsen.
How should I take CELEBREX 200MG CAPSULE? CELEBREX 200MG CAPSULE comes in 200mg strength or as 200mg strength?The recommended dose of CELEBREX 200MG CAPSULE is 200mg for oral absorption. Swallow the tablet without significant altering its efficacy.
The doctor may adjust the dose based on individual needs and response to treatment.
Symptoms of exceeding the recommended dosage are pain in the lower back area, fever, swelling and/or tenderness, diarrhea, abdominal pain, joint pain, moderate swelling and/or weakness.
Before taking CELEBREX 200MG CAPSULE, inform your doctor if you are allergic to, or have had stomach/intestines, blood circulation problems (such as peripheral arterial disease, red itchy welts, inflammatory disease of the disease of the intestines), there is a known high level of CELEBREX 200MG CAPSULE in the body and/or severe liver cirrhosis.
Before using CELEBREX 200MG CAPSULE, inform your doctor about your history of, beyond-term use, use of NSAIDs, use of alcohol,rs (such as during sexual activity),raints, allergies to Celebrex, any other medications or substances, you can identify with your pharmacist.
The doctor may adjust the dose based on your response to the first prescription.
The patient should know that any necessary adjustments may be ignored.
What are the signs of medical improvement?How long do I need to take CELEBREX 200MG CAPSULE? How long you need to take CELEBREX 200MG CAPSULE? How long you take to start taking CELEBREX 200MG CAPSULE depends on the dose given. How long you need to take CELEBREX 200MG CAPSULE depends on the dose given.Celebrex 100mg Tablet contains the active ingredient Celecoxib. It belongs to the family known as non-steroidal anti-inflammatory drugs (NSAID), and specifically a sub-group known as cyclooxygenase-2 (COX-2) inhibitors. It is used in adults for the relief of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. In conditions like rheumatoid arthritis and osteoarthritis, excess production of prostaglandins by your body can lead to pain and inflammation. Celebrex 100mg Tablet works by decreasing the production of prostaglandins, effectively reducing pain and inflammation.
Do not take Celebrex 100mg Tablet if you are allergic to Celebrex 100mg Tablet or any of its ingredients. Inform your doctor if you had reactions to sulfonamide medicines, suffer from ulcers or bleeding in the stomach or intestines, or experienced adverse reactions to NSAID medications like aspirin.
Before starting the treatment, inform your doctor because it is recommended to not take this medicine if you are pregnant or are breastfeeding. Do not take this medicine if you have severe liver or kidney disease, have inflammatory intestinal conditions, or have heart-related issues such as heart failure, heart disease, or circulation problems. Additionally, if you have had surgeries on leg arteries or have a history of blood circulation problems, this medicine usage should be avoided. Celebrex 100mg Tablet contains lactose. If you are sugar intolerant, consult your doctor before using this product. This medicine is for adults only, it is not for use in children.
Inform your doctor about if you have a history of stomach or intestinal ulcers or bleeding (avoid if currently present), are on acetylsalicylic acid or antiplatelet therapies, use blood clotting or corticosteroid medications, or simultaneously use other non-acetylsalicylic NSAIDs like ibuprofen.
Report your doctor if you have conditions such as smoking, diabetes, high blood pressure, high cholesterol, compromised heart, liver, or kidney function, fluid retention, dehydration, past severe allergic reactions to medications, ongoing infections, or are over 65 years old. Monitoring may be necessary. Notably, Celebrex 100mg Tablet could mask fever or infection signs. Remember, alcohol combined with NSAIDs may increase gastrointestinal risks.
Show More=3berman G, Goldstein L, Hatzias-Salvo K, Bhattacharyura S, Ruzbeck H, et al. Historical perspectives on the use of NSAIDs in India.
Non-steroidal anti-inflammatory drugs (NSAIDs) are a class of drugs that are used to relieve pain, inflammation, and swelling. They function by reducing the production of prostaglandins, substances that cause pain and inflammation. Celebrex 100mg Tablet belongs to this group of drugs.noun:ease of stomach or intestine inflammation, pain and swelling, fever, joint pain, muscle pain, shortness of breath, and minor aches and pains.
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