WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISKS
Cardiovascular Risk
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CELEBREX may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All nonsteroidal anti-inflammatory drugs (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. (5.1, 14.6)
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CELEBREX is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. (4, 5.1)
Gastrointestinal Risk
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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. (5.4)
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CELEBREX SUMMARY
CELEBREX is a nonsteroidal anti-inflammatory drug that exhibits anti-inflammatory, analgesic, and antipyretic activities.
Carefully consider the potential benefits and risks of CELEBREX and other treatment options before deciding to use CELEBREX. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5)
]
Osteoarthritis (OA)
CELEBREX is indicated for relief of the signs and symptoms of OA [ see Clinical Studies
]
Rheumatoid Arthritis (RA)
CELEBREX is indicated for relief of the signs and symptoms of RA [ see Clinical Studies
]
Juvenile Rheumatoid Arthritis (JRA)
CELEBREX is indicated for relief of the signs and symptoms of JRA in patients 2 years and older [ see Clinical Studies
]
Ankylosing Spondylitis (AS)
CELEBREX is indicated for the relief of signs and symptoms of AS [ see Clinical Studies
]
Acute Pain (AP)
CELEBREX is indicated for the management of AP in adults [ see Clinical Studies
]
Primary Dysmenorrhea (PD)
CELEBREX is indicated for the treatment of PD [ see Clinical Studies
]
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NEWS HIGHLIGHTS
Published Studies Related to Celebrex (Celecoxib)
Pre-emptive analgesia with pregabalin and celecoxib decreases postsurgical pain
following maxillomandibular advancement surgery: a randomized controlled clinical
trial. [2014]
obstructive sleep apnea... CONCLUSION: Within the limitations of this study, a 1-time preoperative oral dose
Randomized double-blind placebo-controlled trial of celecoxib for oral mucositis
in patients receiving radiation therapy for head and neck cancer. [2014]
morbidity of OM... CONCLUSIONS: Daily use of a selective COX-2 inhibitor, during period of RT for
Efficacy and safety of PG201 (Layla(®)) and celecoxib in the treatment of
symptomatic knee osteoarthritis: a double-blinded, randomized, multi-center,
active drug comparative, parallel-group, non-inferiority, phase III study. [2014]
The objectives of the study are to demonstrate the non-inferiority of PG201
(Layla(®)) 600 mg in comparison with celecoxib 200 mg for the treatment of
symptomatic knee osteoarthritis (OA). In total, 309 patients were randomly
assigned to receive either the test drug, PG201 600 mg (n = 154) or celecoxib 200
mg (n = 155)...
Diclofenac with or without an antiemetic for acute migraine headaches in adults. [2013]
CONCLUSIONS: Oral diclofenac potassium 50 mg is an effective treatment
Celecoxib as a pre-emptive analgesia after arthroscopic knee surgery; a
triple-blinded randomized controlled trial. [2013]
anterior cruciate ligament (ACL) reconstruction and partial meniscectomy... CONCLUSION: It seems that celecoxib as a pre-emptive analgesia agent is effective
Clinical Trials Related to Celebrex (Celecoxib)
CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC) [Completed]
Primary Objectives:
- To determine the feasibility, activity, and toxicity of a novel regimen using a
concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with
unresectable NSCLC.
- To determine the maximal tolerance dose of celecoxib in patients with unresectable
NSCLC treated with irinotecan/cisplatin and concurrent thoracic radiation therapy.
- To correlate the COX-2 expression and other biomarkers with response to the treatment
in the tumor from a pretreatment biopsy specimen.
The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation [Completed]
Celecoxib for Pediatric Adenotonsillectomy [Completed]
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.
Condrosulf vs Celebrex vs Placebo in the Treatment of Knee OA [Active, not recruiting]
The purpose of this study is to confirm the efficacy and safety of 800 mg Chondroitin 4&6
sulfate (Condrosulf) vs placebo once a day for 6 months in the symptomatic treatment of knee
osteoarthritis. A third group, Celecoxib 200 mg (Celebrex) once a day, will be used as
active comparator.
Study of Celebrex (Celecoxib) in Patients With Recurrent Respiratory Papillomatosis [Completed]
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.
Reports of Suspected Celebrex (Celecoxib) Side Effects
Pain (299),
Drug Ineffective (279),
Arthralgia (149),
Arthritis (117),
Malaise (103),
Rash (92),
Abdominal Discomfort (89),
Arthropathy (86),
Drug Hypersensitivity (85),
Pain in Extremity (83), more >>
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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: 2015-08-10
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