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)
Celecoxib: a review of its use for symptomatic relief in the treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. [2011.12.24]
Celecoxib (Celebrex(R)) was the first cyclo-oxygenase (COX)-2 selective inhibitor (coxib) to be introduced into clinical practice. Coxibs were developed to provide anti-inflammatory/analgesic activity similar to that of nonselective NSAIDs, but without their upper gastrointestinal (GI) toxicity, which is thought to result largely from COX-1 inhibition...
Elevated macrophage migration inhibitory factor and decreased transforming growth factor-beta levels in major depression--no influence of celecoxib treatment. [2011.11]
OBJECTIVES: The involvement of an immune process in the pathophysiology of major depression disorder (MDD) was substantiated by studies demonstrating elevated levels of proinflammatory cytokines and prostaglandin E(2) (PGE(2)). Cyclooxygenase-2 (COX-2) inhibitors lead to a reduced production of PGE(2) and have been shown to improve depressive symptoms. We investigated the three immune parameters macrophage migration inhibitory factor (MIF), transforming growth factor-beta (TGF-beta) and soluble CD14 (sCD14) in a randomized, placebo-controlled trial of the COX-2 inhibitor celecoxib as add-on therapy in patients with MDD treated with reboxetine... CONCLUSIONS: MIF is a promising new candidate in the neuro-immune interplay that may link depressive symptoms, altered immune state and HPA-axis dysregulation. Reduced levels of TGF-beta replicate previous findings and support the importance of this regulatory cytokine in major depressive disorder. Copyright (c) 2011 Elsevier B.V. All rights reserved.
A preliminary randomized double-blind clinical trial on the efficacy of celecoxib as an adjunct in the treatment of obsessive-compulsive disorder. [2011.10.30]
Obsessive-compulsive disorder is a common neuropsychiatric condition.The results of this study suggest that celecoxib can be an effective adjuvant agent in the management of patients with OCD; therefore, anti-inflammatory therapies should be further investigated.
A randomized controlled trial of celecoxib to prevent recurrence of nonmuscle-invasive bladder cancer. [2011.10]
Significant morbidity and expense result from frequent recurrences of nonmuscle-invasive bladder cancer (NMIBC) after standard treatment, and carcinoma in situ (Tis) is a poor prognostic factor. Predicated on observational and preclinical data strongly supporting cyclooxygenase-2 (COX-2) in the pathogenesis, and the activity of COX-2 inhibitors, in bladder cancer, we conducted a randomized, double-blind, placebo-controlled trial to determine whether celecoxib could reduce the time-to-recurrence (TTR) in NMIBC patients at high risk for recurrence...
The use of etoricoxib and celecoxib for pain prevention after periodontal surgery: a double-masked, parallel-group, placebo-controlled, randomized clinical trial. [2011.09]
BACKGROUND: Postoperative pain is an adverse effect of periodontal surgeries and may therefore be prevented or minimized. This study was conducted to evaluate the clinical efficacy of two selective cyclooxygenase-2 inhibitors, celecoxib and etoricoxib, on pain prevention after periodontal surgery... CONCLUSION: It was concluded that a single etoricoxib dose is not superior to two split doses of celecoxib when used for pain prevention after open-flap debridement surgery.
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.
Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis [Recruiting]
This is a randomized double blind controlled study to determine if celebrex (celecoxib), a
selective COX-2 inhibitor, can decrease the rate of recurrence in adult and pediatric
patients with recurrent respiratory papillomatosis. All patients will be evaluated for
disease 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 no 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 for Pediatric Adenotonsillectomy [Recruiting]
The investigators' study will involve the administration of either placebo or celecoxib to
children aged 2 to 18 years of age undergoing tonsillectomy and assessing pain relief,
impact on quality of life and side effect profile.
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.
A Phase 4, 6-Week, Randomized Double-Blind, Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex�) Or Naproxen On Blood Pressure In Pediatric Subjects [Recruiting]
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 18 ratings/reviews, Celebrex has an overall score of 6. The effectiveness score is 7.56 and the side effect score is 7.56. 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 50 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Crohn's/Colitis |
| Dosage & duration: | | 100mg taken 2x day for the period of 5 years |
| Other conditions: | | secondary joint inflammation from the Crohn's/Colitis |
| Other drugs taken: | | Asacol, Tramadol | | |
Reported Results |
| Benefits: | | The medication does seem to help with joint inflammation. I find no real benefit for headaches or body aches. There are some studies that show this drug may be beneficial for the treatment of polyps in the large intestine which may be a benefit for me in the long run. |
| Side effects: | | None that I am aware of though I am cautioned by my Doctors that the fact that I have been taking this drug for a long time even though my dosage is not the highest, that it may have an adverse effect on my heart. |
| Comments: | | I take 2 100 mg pills a day. As I said it does help with joint inflammation. My attitude is, "what is the alternative". Since I do not have an expiration date stamped on me, I will not know if this drug lengthened or shortened my life. But it does help me today to lead what I think of as a more 'normal' life. |
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| | Celebrex review by care giver of 79 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | arthritis pain |
| Dosage & duration: | | 200mg taken 2x a day for the period of 3 days |
| Other conditions: | | a-fib |
| Other drugs taken: | | warfarin | | |
Reported Results |
| Benefits: | | none noted- moderate pain relief of arthritis |
| Side effects: | | a severe stroke on the 4th day- hemorrhage in the brain= this was an extremely active and fit person |
| Comments: | | This drug should not have been given to this patient. It killed him. He never recovered from this stroke- Right side paralysis and unable to eat or drink/swallow ever again |
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Page last updated: 2011-12-09
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