Generic Name: Celebrex

What is Celebrex?

EMMA ALBERICI: The world's biggest drug company, Pfizer, manufactures Celebrex. Over the weekend, it posted this notice on its website, warning patients about the cardiovascular safety of the drug based on an analysis of two long-term trials. They found that patients taking 400 to 800mg of the drug daily in the cancer prevention trials were 2.

Despite the news, Nadine Garland remains a Celebrex devotee. It's part of a relatively new class of drugs called Cox-2 inhibitors. The other product in the class, Vioxx, was pulled from the market by rival drug company Merck after a study showed that the risk of heart attacks and strokes tripled among patients taking it over a long term.

DR BILL GLASSON: A lot of doctors had transferred their patients from Vioxx to Celebrex. Now, if Celebrex is also removed from the market, it's going to make it difficult for doctors to decide where they should now move, because if they now have to put them back on to the group of drugs called non-steroidal anti-inflammatories, those drugs have a much higher incidence of gastric bleeds, gastric ulcers, so we've got ourselves a little bit cornered.

NEWS ANCHOR: The FDA says it has great concern about the safety of Celebrex and is recommending doctors and patients find alternatives.

Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine. This medicine may cause stomach bleeding.

Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and smoking.

Consult your doctor or pharmacist for more information. Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs, nonprescription drugs, and herbal products. Older adults may be more sensitive to the side effects of this drug, especially stomach bleeding and kidney problems. Before using this medication, women of childbearing age should talk with their doctor s about the benefits and risks such as miscarriage, trouble getting pregnant.

Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. This medication passes into breast milk. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.

How should I take Celebrex?

Pharmacokinetic interactionsCelecoxib is an inhibitor of CYP2D6. The plasma concentrations of drugs that are substrates of this enzyme may be increased when celecoxib is used concomitantly.

Examples of drugs which are metabolised by CYP2D6 are antidepressants tricyclics and SSRIsneuroleptics, anti-arrhythmic drugs, etc. The dose of individually dose-titrated CYP2D6 substrates may need to be reduced when treatment with celecoxib is initiated or increased if treatment with celecoxib is terminated. Concomitant administration of celecoxib 200 mg twice daily resulted in 2. These increases are due to celecoxib CYP2D6 inhibition of the CYP2D6 substrate metabolism.

What should I avoid while taking Celebrex?

Therefore, use of CELEBREX during the third trimester of pregnancy should be avoided. NSAIDs including celecoxib should be used only with caution in patients with systemic onset JRA, due to the risk of disseminated intravascular coagulation.

Poor Metabolizers of CYP2C9 substrates 8. Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare.

Celebrex side effects

The adverse drug reactions listed above for the polyp prevention trials are only those that have been previously recognized in the post-marketing surveillance experience, or have occurred more frequently than in the arthritis trials. Uncommon: helicobacter infection, herpes zoster, erysipelas, bronchopneumonia, labyrinthitis, gingival infection, lipoma, vitreous floaters, conjunctival haemorrhage, deep vein thrombosis, dysphonia, haemorrhoidal haemorrhage, frequent bowel movements, mouth ulceration, allergic dermatitis, ganglion, nocturia, vaginal haemorrhage, breast tenderness, lower limb fracture, blood sodium increased.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. Single doses up to 1200 mg and multiple doses up to 1200 mg twice daily have been administered to healthy subjects for nine days without clinically significant adverse effects. In the event of suspected overdose, appropriate supportive medical care should be provided e.

Dialysis is unlikely to be an efficient method of drug removal due to high protein binding.

Common Celebrex ide effects may include:

  • CELEBREX doses of 100 mg twice daily and 200 mg twice daily were similar in effectiveness and both were comparable to naproxen 500 mg twice daily.

  • The PreSAP trial did not demonstrate a statistically significant increased risk for the same composite endpoint adjudicated :Clinical trials of other COX-2 selective and non-selective NSAIDs of up to three-years duration have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.

  • Take Celebrex with food or milk to reduce any stomach upset.

  • These may affect the way your medicine works.

In vivo studies have shown the following: AspirinWhen NSAIDs were administered with aspirin, the protein binding of NSAIDs were reduced, although the clearance of free NSAID was not altered. FluconazoleConcomitant administration of fluconazole at 200 mg once daily resulted in a two-fold increase in celecoxib plasma concentration. MutagenesisCelecoxib was not mutagenic in an Ames test and a mutation assay in Chinese hamster ovary CHO cells, nor clastogenic in a chromosome aberration assay in CHO cells and an in vivo micronucleus test in rat bone marrow.

Where can I get more information?

  • Clinical trials with celecoxib have shown renal effects similar to those observed with comparator NSAIDs.

  • You may report side effects to FDA at 1-800-FDA-1088 or at www.