Cardiovascular Risk
- CELEBREX may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs may have a similar risk. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS and CLINICAL STUDIES).
- CELEBREX is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal Risk
- NSAIDs, including CELEBREX, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).
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CELEBREX SUMMARY
CELEBREX is a nonsteroidal anti-inflammatory drug.
CELEBREX is indicated:
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For relief of the signs and symptoms of osteoarthritis.
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For relief of the signs and symptoms of rheumatoid arthritis in adults.
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For the management of acute pain in adults (see CLINICAL STUDIES).
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For the treatment of primary dysmenorrhea.
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To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP), as an adjunct to usual care (e.g., endoscopic surveillance, surgery). It is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in FAP patients. It is also not known whether the effects of CELEBREX treatment will persist after CELEBREX is discontinued. The efficacy and safety of CELEBREX treatment in patients with FAP beyond six months have not been studied (see CLINICAL STUDIES, WARNINGS and PRECAUTIONS sections).
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NEWS HIGHLIGHTS
Published Studies Related to Celebrex (Celecoxib)
Phase II, Randomized, Placebo-Controlled Trial of Neoadjuvant Celecoxib in Men With Clinically Localized Prostate Cancer: Evaluation of Drug-Specific Biomarkers. [2009.10.20]
PURPOSE Cyclooxygenase-2 (COX-2) is a potential pharmacologic target for the prevention of various malignancies, including prostate cancer... We caution against using celecoxib 400 mg twice daily as a preventive agent for prostate cancer in additional studies.
Celecoxib and exemestane versus placebo and exemestane in postmenopausal metastatic breast cancer patients: a double-blind phase III GINECO study. [2009.08]
The aim of this study was to evaluate antitumor effects of cyclooxygenase-2 inhibitors in breast carcinoma and their ability to act synergistically with aromatase inhibitors (AIs). Postmenopausal metastatic breast cancer patients without previous adjuvant AI treatment received exemestane 25 mg/days plus either celecoxib 400 mg twice daily or placebo...
Celecoxib in the Management of Acute Renal Colic: A Randomized Controlled Clinical Trial. [2009.07.08]
OBJECTIVES: To evaluate the efficacy of celecoxib as an analgesic and medical expulsive agent in acute renal colic... CONCLUSIONS: Celecoxib does not facilitate stone passage or decrease narcotic requirements in patients with acute renal colic.
Comparing safety and efficacy of first-line irinotecan/fluoropyrimidine combinations in elderly versus nonelderly patients with metastatic colorectal cancer: findings from the bolus, infusional, or capecitabine with camptostar-celecoxib study. [2009.06.15]
BACKGROUND: Irinotecan-based chemotherapy regimens are 1 option for treatment of metastatic colorectal cancer (mCRC). The authors report the safety and efficacy of such regimens in elderly patients using a large phase III trial (bolus, infusional, or capecitabine with camptostar-celecoxib [BICC-C]) cohort... CONCLUSIONS: Irinotecan/fluoropyrimidine combinations are well tolerated in the elderly population, with similar efficacy to that found in nonelderly patients in first-line mCRC. (c) 2009 American Cancer Society.
Anti-Helicobacter pylori therapy followed by celecoxib on progression of gastric precancerous lesions. [2009.06.14]
AIM: To evaluate whether celecoxib, a selective cyclooxygenase 2 (COX-2) inhibitor, could reduce the severity of gastric precancerous lesions following Helicobacter pylori (H pylori) eradication... CONCLUSION: H pylori eradication therapy followed by celecoxib treatment improves gastric precancerous lesions by inhibiting COX-2 activity, inducing apoptosis, and suppressing cell proliferation and angiogenesis.
Clinical Trials Related to Celebrex (Celecoxib)
Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis [Recruiting]
This is a randomized double blind controlled study to determine if celbrex (celecoxib), a selective COX-2 inhibitor, can decrease the rate of recurrence in adult patients with recurrent respiratory papillomatosis. All patients will be evaluated for diesease severity at enrollment and at 3 month intervals for 30 months. After randomization, patients in the early treatment arm will begin celecoxib 6 months after enrollment. The delayed treatment arm will begin celecoxib 18 months after enrollment. All patients will receive celecoxib for 1 year. During the time that patients do not receive celecoxib, they will receive a placebo capsule with the same appearance. Follow-up visits will occur at three month intervals for the duration of the study.
Celecoxib as Adjuvant Biologic Therapy in Patients With Head and Neck and Lung Cancer [Active, not recruiting]
Primary Objectives:
1. To examine the effect of celecoxib treatment on histological response (defined in
Appendix H), markers of proliferation (Ki-67), and apoptosis. Secondary endpoints
include time to second primary or recurrence and survival.
2. To examine the toxicity associated with celecoxib administration in patients with
previously treated HNSCC or NSCLC.
Celebrex Total Knee Arthroplasty Study [Terminated]
This study will investigate the benefits of administering celecoxib (Celebrex), a selective
cyclooxygenase - 2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing
elective unilateral primary total knee arthroplasty (TKA) from the pre-operative phase to the
management of post total knee replacement pain, and through the 6 weeks of physical therapy
and rehabilitation.
Celecoxib (Celebrex) Versus Placebo in Men With Recurrent Prostate Cancer [Completed]
The purpose of this study is to learn the effects (both good and bad) that celecoxib has on
prostate cancer and patients with prostate cancer. This study is looking at what effects
celecoxib has on prostate specific antigen (PSA) level. PSA is a marker specific to prostate
cancer. An increase or decrease in this level in the blood can indicate if a patient's
prostate cancer is getting worse or better.
Study Of "Continuous Use" Of Celecoxib Vs. "Usual or Intermittent Use" [Completed]
To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious
than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee
and hip.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 11 ratings/reviews, Celebrex has an overall score of 6.82. The effectiveness score is 7.27 and the side effect score is 8.73. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Celebrex review by 55 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | arthritis pain |
| Dosage & duration: | | 100 (dosage frequency: twice a day) for the period of PRN |
| Other conditions: | | hypothyroid, insulin resistance |
| Other drugs taken: | | levothyroid, metformin | | |
Reported Results |
| Benefits: | | Reduction of pain and inflammation. |
| Side effects: | | Edema. |
| Comments: | | Self administration PRN for joint pain, inflammation. |
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| | Celebrex review by 37 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | anti-inflammatory/pain |
| Dosage & duration: | | 2 tablets every several hours taken every several hrs for the period of 2 days |
| Other conditions: | | just out of surgery for hernia |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | anti-inflammatory and pain reduction claims. I didn't notice much difference in the pain but the inflammation went down after a few weeks (not while taking the medication). |
| Side effects: | | Slight dizziness- however I am extremely sensitive to medications. I am unable to take any narcotics or strong medications because it makes me nauseous |
| Comments: | | Take the medication every several hours as prescribed for 3 days. I didn't think this medication did anything. |
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| | Celebrex review by 53 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Mild bursitis in left hip. |
| Dosage & duration: | | 400mg capsule. taken once daily. for the period of Two weeks. |
| Other conditions: | | Chronic Pancreatitis & Hypertension |
| Other drugs taken: | | Hydrochlorothiazide 25mg | | |
Reported Results |
| Benefits: | | Minimal, if any. |
| Side effects: | | Occassional nausea and slight dizziness. |
| Comments: | | After two weeks of taking Celebrex I was able to walk easier but I feel the progress was due to staying off the leg and keeping it elevated. Celebrex did absolutely nothing for the intense pain. When the prescription ran out I started taking 800mg ibuprofen (prescription) every 6 hrs and within 4 days I was walking normally. |
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Page last updated: 2009-10-20
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