Potential Risks and Complications of Celecoxib

It is recommended that patients consider the increased risk of major cardiovascular, gastrointestinal, kidney, and liver complications before taking celecoxib. Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Celecoxib Safety Debated

The safety of the COX-2 inhibitor celecoxib (brand name Celebrex) came under scrutiny when the other COX-2 inhibitors were taken off the market more than a decade ago.

The medical literature includes studies showing an increased risk of serious cardiovascular problems with celecoxib, as well as other NSAIDs.¹Solomon SD, Mcmurray JJ, Pfeffer MA, et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med. 2005;352(11):1071-80.^,2Solomon SD, Wittes J, Finn PV, et al. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008;117(16):2104-13.^,3Bhala N, Emberson J, Merhi A, et al. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. The Lancet, Vol. 382, No. 9894, p769-779, 31 August 2013. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)60900-9/fulltext.

The Food and Drug Administration (FDA) position is that the risk for certain patients is worth the benefit of celecoxib. Taking the lowest effective dose of celecoxib, for the shortest time possible, is advised by the FDA, and prominent warnings are required on packages for all nonsteroidal anti-inflammatory (NSAIDS), including celecoxib, highlighting the risks.⁴FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes. July 9, 2015. www.fda.gov/Drugs/DrugSafety/ucm451800.htm.

See NSAIDs: Non-Steroidal Anti-Inflammatory Drugs

Results of a long-term, multinational clinical trial that began in 2006 to assess and compare the risk of celecoxib with other common NSAIDs have not yet been released.⁵Becker MC, Wang TH, Wisniewski L, et al. "Rationale, design, and governance of Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen (PRECISION), a cardiovascular end point trial of nonsteroidal anti-inflammatory agents in patients with arthritis." American Heart Journal 157.4 (2009): 606-612.

See Common NSAIDs for Back and Neck Pain

Heart-Related Risk Factors

The FDA has revised its warnings for people taking prescription NSAIDs, which include celecoxib, to include these findings:

• The added risk of a heart attack or stroke is not limited to long-term use. The risk can increase even during the first weeks of using an NSAID.
• People with heart disease or its risk factors have a higher rate of heart attack or stroke, but there is also an elevated risk for those without heart problems or heart disease risk factors.
• Research indicates that the risk goes up as the dose increases.
• The risk of heart failure also increases in people using NSAIDs.

Keeping the doctor informed of any medication prescribed by another doctor for the patient is always advised, but it is particularly important for those with heart problems.

Who Should Not Take Celecoxib

Celecoxib is not recommended for people:

• With stomach or intestinal bleeding
• Who have had an asthma attack or other allergic reaction to aspirin or to any other NSAID or sulfa drug
• Have had a coronary artery bypass graft (CABG) recently

Caution is recommended when considering celecoxib for a child with systemic onset juvenile rheumatoid arthritis. This could increase the risk of a serious bleeding/clotting condition known as disseminated intravascular coagulation.

See Rheumatoid Arthritis in the Spine

Celecoxib use should be avoided in patients with advanced renal disease and used with caution in patients with moderate hepatic (liver) impairment; dosage adjustment is recommended.

The long-term use of NSAIDs in women of reproductive age may be associated with infertility that is reversible upon discontinuation of the medication.

See Potential Risks and Complications of NSAIDs

Celecoxib Side Effects

In addition to heart-related risks such as heart attack and stroke, these side effects may be experienced:

• Serious skin reactions
• Serious liver problems
• Kidney problems, particularly if the patient becomes dehydrated
• Gastrointestinal problems. Diarrhea, gastroesophageal reflux disease (GERD), nausea, and vomiting are the most common gastrointestinal side effects. Stomach bleeding and ulcers can also occur. While celecoxib is generally less irritating to the stomach than other NSAIDs in the short term, the long-term effect is unclear. Gastrointestinal problems tend to occur more often when the person drinks alcohol while taking the medication. See Can GERD Cause Back Pain?
• Hypertension, or high blood pressure
• Dysphagia (difficulty swallowing)
• Dizziness
• Difficulty breathing or shortness of breath, also called dyspnea
• Sinusitis and upper respiratory infections

Among those with juvenile idiopathic arthritis, the most common adverse reactions—affecting 5% or more of patients—are abdominal pain, arthralgia (joint pain), cough, diarrhea, fever, headache, upper respiratory infection, nausea, upper abdominal pain, and vomiting.

It is best to let the doctor know about any side effects that occur. The doctor may conduct lab tests regularly to monitor the effects of the medication.

Considerations When Taking Celecoxib

It may be helpful to take these other health factors into account:

• Pregnancy. Women who are pregnant or breastfeeding—or planning to get pregnant soon—are advised to discuss their medical history and current status with the doctor before celecoxib is prescribed. Medical studies have shown the medication poses a risk of harm to the baby when taken late in pregnancy, and risk or safety earlier in pregnancy has not been established.⁶Celecoxib (Oral route). PubMed Health, U.S. National Library of Medicine. www.ncbi.nlm.nih.gov/pubmedhealth/PMH0044745/#DDIC601969.side_effects_section.

   

  Celecoxib is rated a Category C for pregnancy safety prior to 30 weeks’ gestation and Category D from 30 weeks’ gestation onward, under the FDA’s ratings for medication safety during pregnancy. The ratings run from A through X, with A being the safest.
• Age. Older adults are more prone to side effects in general, and are more likely than young adults to experience age-related kidney or stomach difficulties.
• Drug interactions. Medications including blood thinners, diuretics (water pills), blood pressure medication, and steroids may interfere with celecoxib’s effectiveness. Taking other NSAIDs or acetaminophen at the same time as celecoxib may harm the liver.

  See Acetaminophen for Back Pain

• Planned surgery or medical tests. Celecoxib may need to be stopped prior to surgery or medical tests. Checking with the surgeon in advance is advised.
• Liver impairment. A dosage reduction should be considered in patients with moderate hepatic impairment and celecoxib use in not recommended in patient with severe hepatic impairment.

This is not a comprehensive list of potential risks and complications associated with celecoxib. Patients should communicate with their doctor and pharmacist to determine their specific situation.

Individual Needs Assessed

Working with the doctor to find the safest and most effective medication options is the recommended approach. The doctor can evaluate each patient's individual risk factors (e.g. the patient's likelihood for developing certain health problems, including heart attack, stroke, and gastrointestinal problems) and health needs to determine the safest and most effective treatment options. The physician will also take into consideration the patient's previous experience with NSAIDs.

In addition to discussing celecoxib with the doctor, keeping the doctor up-to-date on all other medications being taken—both prescription and over-the-counter—as well as vitamins and nutritional supplements is the best course of action.