The FDA is reviewing the safety and effectiveness of NSAIDs (non-steroidal anti-inflammatory drugs) including celecoxib. Celecoxib is a prescription NSAID. Celecoxib has been linked to an increased risk of heart attack, stroke, and certain types of cancer. In clinical trials of Celebrex, a Celebrex-like drug, patients who took celecoxib for heart disease had a slightly greater likelihood of developing the condition. Celebrex is not FDA approved to treat NSAIDs. Celecoxib is considered a nonsteroidal anti-inflammatory drug (NSAID).
The FDA has issued a warning for the use of celecoxib in post-marketing reports. The agency has determined that there is a risk of serious harm to an unborn child. The FDA has also determined that the use of celecoxib should be restricted. Celebrex has been linked to an increased risk of death from a serious form of breast cancer in women who have undergone a hysterectomy.
A study published in the Journal of the American Medical Association in 2002 estimated that women who were prescribed celecoxib experienced an increased risk of heart attack, stroke, and blood clots compared with those who received placebo. The FDA has determined that there is a risk of serious harm to an unborn baby. The study showed that celecoxib may increase the risk of breast cancer in women who have undergone a hysterectomy and for those who have been on tamoxifen. A study published in the British Medical Journal in 2005 estimated that women who were prescribed celecoxib experienced an increased risk of breast cancer compared with those who received placebo. The FDA has determined that there is a risk of serious harm to an unborn child.
A Study in the Journal of the American Medical Association in 2002 estimated that women who were prescribed celecoxib experienced an increased risk of heart attack, stroke, and blood clots compared with those who received placebo.Alternate Name:Celebrex
Description:Ortho-ileenrapid-crest-celebrex is a prescription drug used to treat pain and inflammation in osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, and acute pain. The generic alternative is Exeter Pharmaceutical Solutions US LLC.
Dosage Form:CBT
Administration Route:By mouth
Drug Class:Anticoagulant
Generic Available:Yes
Strength:20 MG
Warnings:Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, bleeding problems, glaucoma, heart rhythm disorders, or taking other medications that may affect the rhythm of your kidneys. This medicine may cause an upset stomach. If you become pregnant or breastfeeding, call your doctor.
Do not take other antidepressants or high blood pressure medicine after the labels on the tablets tell you what your medicine is for.Some people have serotonin syndrome in their brain. This may happen when you eat a lot, drink a lot of alcohol, or take a sleeping pill. Tell your doctor if you have any mental health conditions, including major depression, anxiety, or psychosis.
This medicine may cause a heart rhythm problem. Your doctor may need to change the doses of your medicines or monitor you carefully for symptoms of irregular heartbeats.Tell your doctor if you have conditions like sickle cell disease, multiple myeloma, or leukemia, or if you are taking any other medications. Your doctor will probably start you on a different medicine and stop you on its own.
Keep this medicine in the sealed package for no longer than your doctor tells you.Using this medicine for the entire duration prescribed by your doctor will not increase your risk of getting an unwanted side effect. Taking more medicine than the prescribed dose will not treat the problem or will increase your risk of getting side effects not listed above.
This medicine may cause low blood pressure. If you feel very faint or dizzy, do not worry, your doctor will prescribe you a lower dose of this medicine. You can use a lower dose if your doctor tells you to. Do not stop using this medicine without consulting your doctor.
This medicine may make you faint during sexual activity. Do not drive or operate machinery until you know how you will feel. If you feel faint, consult your doctor.
This medicine may make you have problems absorbing food. Avoid alcoholic beverages or food. Ask your pharmacist for help if you have any food or drink too much alcohol while using this medicine.
This medicine may make your skin more sensitive to the sun. Limit your time in the sun. Use a sunscreen. Be sure to wear protective clothing. Tell your doctor and pharmacist if you are touchy.
This medicine may make your periods light. Do not use sunbeds or sunscreen while using this medicine.
This medicine may make the signs of heart failure worse.
Avoid getting diarrhea by eating a lot, drinking a lot, or using other products that contain magnesium. Ask your doctor or pharmacist.
Your doctor may call a few other medicines into your medicine to make sure you are safe while using this medicine. Talk to your doctor if you are using any other medicines that you are already taking. Do not start, stop, or change the dosage of any medicines while you are using this medicine.
This medicine may make the signs of irregular heart beat worse.
If you have any new or worsening symptoms, tell your doctor.
Call your doctor at once if you notice any change in your menstrual pattern or irregular bleeding.
Low blood pressure may be a symptom of low blood pressure.
Low blood pressure may cause your heart to beat faster or slow, as it does when you are not getting enough fluid from your body.
Do not drive, use machinery, or do anything that needs mental alertness to make up the time in your life.
This medicine may make you more sensitive to sunlight. Avoid sunbeds and sunscreen while you are using this medicine.
This medicine may cause a problem with the blood. Your doctor will need to change the dose of your medicines. Do not stop using this medicine without first consulting your doctor.
The FDA's, with its,andthat the new labeling() will provide a clear, easy-to-follow, and generally accurate list of celecoxib and other medications that patients are prescribed to take, according to the manufacturer's website.
The drugisknown asCelebrex®. Itin the classof nonsteroidal anti-inflammatory drugs,including. Its primary uses are to manage pain and inflammation. It can also be used to relieve arthritis, such as in cases of rheumatoid arthritis.
Thenew labeling will include information about Celebrex and its side effects, including information about the medication's potential interactions with other drugs and foods, as well as new drug information.
This press release contains forward-looking statements, which are to be reviewed by an attorney for the FDA and the pharmaceutical industry as soon as possible. The company's future outlook is subject to significant risks and uncertainties, including and including:
The FDA is reviewing this information and will update its product labeling and safety information as needed. If required, this information will be reviewed by the FDA's independent regulatory office, which will include the agency's own independent review process and/or the agency's own independent regulatory authority.
FDA has received, including a submission to the FDA's Office of Criminal Investigation, for review. If you have concerns, please reach out to the FDA's Office of Criminal Investigation for further information.
For additional information about the FDA's review process,, or your company, please visit the FDA's website at
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Please note that in order to release forward-looking statements, we undertake to update our most current and future information or information about our most current information to reflect events or circumstances. For more information about forward-looking statements, please see our filings with the Securities and Exchange Commission, including our Annual Report on Form 20-F for the year ended December 31, 2023 and our other filings with the Securities and Exchange Commission.
The information at issue in this press release is subject to:
FDA'sapproval withCelebrex® is based on our assessment of the clinical, epidemiological, and demographic characteristics of the individual patients in our database. These characteristics may include:
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 can I take CELEBREX 200MG CAPSULE?Take CELEBREX 200MG CAPSULE at about an hour before your pain is most likely to be treatable.
Before taking CELEBREX 200MG CAPSULE, inform your doctor about all the co-morbidities you have, especiallyognitive disorder,polycyancid,ementroosidosis,gout (joint pain and/or)]and/or history of respiratory tract infection, bronchiectasis, tracheitis.
Some common side effects of taking CELEBREX 200MG CAPSULE include hot flushes,vedgery, cough, running nose, sore tongue, dry mouth, constipation, diarrhea, stomach pain, constipation with/ during the day, wind, stomach cramps, stomach pain Caution: Give with food or drink. The following may be true:
Uses of CELEBREX 200MG CAPLEOsteoarthritis: • Lasts longer than typical and improves through walking • Increases awareness of the importance of proper evaluation and management of joint pain • Affects joints more than once • Used for both rheumatoid arthritis and osteoarthritis [see Warnings and Precautions]. CELEBREX 200MG CAPSULE is used to manage osteoarthritis. • In ankylosing spondylitis, It helps relieve pain and stiffness in osteoarthritis and ankylosing spondylitis [see Warnings and Warnings]. • In children aged 2 to 17 years It is indicated in children with juvenile rheumatoid arthritis and juvenile ankylosing spondylitis [see Warnings and Warnings]. NSAID:
CELEBREX 200MG CAPSULE belongs to the group of NSAIDs and works by blocking the Coxib enzyme type-1. Celecoxib belongs to this group of medicines. It helps relieve pain, inflammation, and pain associated with osteoarthritis, rheumatoid arthritis and asthma.
Can I take CELEBREX 200MG CAPSULE if I am pregnant?Do not take CELEBREX 200MG CAPSULE if you are pregnant unless your doctor says so.
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