WASHINGTON —The Food and Drug Administration on Thursday approved the first prescription drug to treat a new form of arthritis called the Cox-2 inhibitor Celebrex, making it the first to do so.
The drug, called celecoxib, treats osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, in people ages 45 and older who are taking Cox-2. It is also approved to help prevent the recurrence of rheumatoid arthritis, ankylosing spondylitis, after being on the treatment for more than a year.
The FDA said it will issue a copy of the order to Pfizer, which manufactures the drug.
Celebrex is a COX-2 inhibitor that works by blocking the COX-1 enzyme, which is a type of chemical that makes prostaglandins. It is the first drug to do so.
The new drug is available in 50mg and 100mg capsules for $3, while patients can also purchase a 30-day supply for $3.
The drug has been available since the Food and Drug Administration approved it in 2002, after the FDA warned doctors that Celebrex increased the risk of heart attacks and strokes in patients who took it. The drug's manufacturer, Pfizer, said the risk is low.
Pfizer's warning came in a study that found a small increased risk of heart attack in patients taking Cox-2 inhibitors and that it's unclear how well the study could be conducted.
The FDA said it would consider a new study in the next month to see whether Celebrex can treat patients who are at increased risk of heart attack.
The drug was originally approved to treat arthritis but the FDA had already rejected the drug twice because of safety concerns.
Pfizer, which produces Celebrex, said it's working to bring it to market.
Patients on Celebrex who are taking the drug will have to wait at least six months before the drug will become available to them, Pfizer said in a statement. If the drug gets to the market after the FDA approved it, it will be available to treat people who are at increased risk of heart attack.
Pfizer, which manufactures the drug, said it's working with the FDA to ensure the safety of the drug, and will work with Pfizer to add more information about the drug to the public's health report, a public health emergency.The new drug is available in 50mg and 100mg capsules for $3, and patients can also purchase a 30-day supply for $3.
The drug is a new type of Cox-2 inhibitor called a nonsteroidal anti-inflammatory drug (NSAID), which means it blocks the COX-1 enzyme from making prostaglandins. It is a type of drug called a COX-2 inhibitor, which means it blocks the COX-1 enzyme from making prostaglandins.
The FDA approved the drug as the first drug to treat rheumatoid arthritis and ankylosing spondylitis in 2002, and as the first drug to prevent the recurrence of rheumatoid arthritis and ankylosing spondylitis in 2003.
The agency said that celecoxib, the active ingredient in Celebrex, is the second drug to do so in the next two decades, after it was approved in the 1990s.
Pfizer, which has been promoting the drug for over a decade, said its new drug, called Cox-2, is available in 50mg and 100mg capsules for $3, while patients can also purchase a 30-day supply of the drug for $3.The FDA said it's working with Pfizer to ensure the safety of the drug, and will work with Pfizer to add more information to the public's health report, a public health emergency.
Pfizer, which manufactures the drug, said it's working to ensure the safety of the drug, and will work with Pfizer to add more information to the public's health report, a public health emergency.The Food and Drug Administration approved Celebrex as the first drug to treat ankylosing spondylitis in 2002 and as the first drug to prevent the recurrence of rheumatoid arthritis and ankylosing spondylitis in 2003. Pfizer, which has been promoting the drug for over a decade, said it's working with the FDA to ensure the safety of the drug, and will work with Pfizer to add more information to the public's health report, a public health emergency.If you or a loved one is struggling with allergic reactions to prescription antihistamines, you’ve come to the right place. Whether you’re dealing with a respiratory infection, hay fever, or asthma, allergy medications can provide quick and reliable treatment.
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Celebrex is a medication that helps reduce inflammation and pain associated with arthritis and other forms of pain. This prescription medication has been approved for use in adults and children 12 years of age and older. It is usually taken once or twice daily with or without food to help reduce inflammation and pain. It is important to follow the directions on the medication label to avoid any side effects. The dosage and length of treatment depend on your individual needs and the type and severity of the pain. If you have trouble swallowing capsules, or you have trouble swallowing tablets, it is important to take a capsule with each dose. If you have trouble swallowing capsules, you should always take the medication with food.
Side effects may include headache, stomach upset, upset stomach, drowsiness, drowsiness, feeling weak, and dizziness. These side effects are rare and temporary. If you experience any of these symptoms or if you have any concerns, please reach out to your doctor.
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.
How can I get more information?This product may be used in patients with diabetes or kidney disease, even if there are no benefits to Celebrex 100mg Tablet. Refer to the manufacturer's instructions for use.
How often should I use this product?This product is for adults only, it is not for use during pregnancy or if you are breast-feeding. Note: If you experience signs of stomach or intestinal ulcers or bleeding, contact your doctor.
To reduce the chance of experiencing symptoms such as fever or swelling, wear comfortable clothing and bring plenty of fluids unless your doctor advises you otherwise. Do not use this product during the second or third trimester of pregnancy unless your doctor tells you to.
If you are using this product during the middle of the month, use an exception to. This product is for use as soon as possible. Most people who use this product plan early.
Store at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Keep out of reach of children.
Caution is advised during use of this product. People with a history of stomach or intestinal ulcers or bleeding, NSAID prescription medications like aspirin, or anti-inflammatory medications, or corticosteroids should use this product only under strict medical supervision. Consult your doctor before using Celebrex 100mg Tablet if you are pregnant or breastfeeding, if you have severe pain or fever, or if you are dehydrated, because Celebrex 100mg Tablet can cause serious problems. Stop use and contact your doctor immediately if you develop symptoms such as serious skin rashes, swollen face, or blisters. This precaution is only advised for adults and children, not for the children of child-specific manufacturers.
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