Celebrex Risks, Warnings, and Complications

• SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS: Clinical trials have shown that taking COX-2 selective and nonselective NSAIDs increases the risk of serious cardiovascular thrombotic events (blood clots leading to heart attack or stroke), which can be fatal. 

  Before starting Celebrex treatment, tell your doctor if you have a history of cardiovascular disease. Serious cardiovascular thrombotic events can occur as early as the first week of treatment and are more common in people taking higher doses of Celebrex. To minimize the risk of heart attack or stroke, your doctor will prescribe the lowest effective dose of Celebrex for the shortest time possible. 

  Seek emergency medical care if you develop chest pain, sudden numbness or weakness, confusion, trouble speaking, or trouble walking. 

  Note: NSAIDs, including Celebrex, are contraindicated in patients who have recently undergone coronary artery bypass graft (CABG or heart bypass surgery) recently due to an increased risk of myocardial infarction (heart attack) and stroke. The use of Celebrex should also be avoided in people who have had a recent heart attack.

GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION: Celebrex and other NSAIDs can cause serious adverse effects in the gastrointestinal (GI) tract (esophagus, stomach, intestines), including bleeding, ulceration, and perforation, which can be fatal. These serious complications can occur at any time during treatment with Celebrex and without warning. 

Risk factors for GI complications include: 

• Pre-existing peptic ulcer disease.
• Simultaneous use of certain other medications such as oral corticosteroids, anticoagulants (blood thinner medicines that prevent blood clots), antiplatelet drugs like aspirin, and selective serotonin reuptake inhibitors (SSRIs).
• Higher dose or longer duration of NSAID use.
• Smoking.
• Alcohol use.
• Elderly patients.
• Advanced liver disease.
• Coagulopathy.
• Poor health status.

To lower the risk of gastrointestinal adverse effects, your doctor will prescribe the lowest effective dosage of Celebrex for the shortest possible duration to control your symptoms. They will monitor you carefully, especially if you are on aspirin for cardiac prophylaxis (to lower the risk of heart disease).

Do not take more than one type of NSAID at the same time. Seek emergency medical care if you develop signs of gastrointestinal bleeding such as coffee grounds vomit, blood in stool, black tarry stools, dizziness, or confusion.

• HEPATOTOXICITY: There are reports of elevations in liver enzymes (ALT or AST) in patients receiving NSAIDs. There are also rare reports of fatal liver injury, including fulminant hepatitis, liver necrosis, and liver failure.

  Seek immediate medical attention if you develop right upper stomach pain, loss of appetite, nausea, diarrhea, yellowing of the skin or eyes, fatigue, low energy, itching, or flu-like symptoms. 

• HYPERTENSION: Celebrex and other NSAIDs can cause new onset or worsening hypertension (high blood pressure), which can increase the risk of cardiovascular disease and events like heart attack or stroke. Blood pressure medications (for example, angiotensin-converting enzyme (ACE) inhibitors and diuretics (water pills)) may not be as effective while on NSAIDs. Your doctor will monitor your blood pressure while starting you on Celebrex and throughout treatment with this medicine. 

• CONGESTIVE HEART FAILURE AND EDEMA: Meta-analysis of randomized controlled trials has shown that patients treated with selective COX-2 inhibitors and nonselective NSAID-treated patients are at an approximately two times higher risk of hospitalizations for congestive heart failure compared to placebo-treated patients. In addition, there are reports of fluid retention and edema (swelling) in some NSAID-treated patients. Celebrex can blunt the effects of medications used to treat these medical conditions, for example, diuretics (water pills), angiotensin-converting enzyme (ACE) inhibitors, and angiotensin receptor blockers (ARBs).

  Your doctor will carefully weigh the benefits versus risks before prescribing Celebrex if you have heart failure. If you have heart failure and take Celebrex, your provider will monitor you carefully for signs of worsening. Seek immediate medical attention for unexplained or sudden weight gain.

• RENAL TOXICITY AND HYPERKALEMIA: Taking NSAIDs long-term can lead to kidney injury. Risk factors include pre-existing impaired kidney function, hypovolemia, dehydration, liver disease, heart failure, elderly patients, and those taking blood pressure medications such as ACE inhibitors or ARBs. Stopping NSAID therapy usually results in recovery of kidney function. 

  Before starting Celebrex, your doctor will correct the volume status if you are dehydrated or hypovolemic. They will carefully monitor kidney function throughout treatment with this medicine if you have kidney disease, liver disease, or heart failure. Use of Celebrex should be avoided in patients with advanced kidney disease unless the benefits outweigh the risk of worsening kidney function. 

  There are reports of hyperkalemia (high serum potassium levels) in patients treated with NSAIDs, including patients with no history of renal impairment (kidney problems). Keep all your medical and laboratory appointments while on Celebrex. Your healthcare provider may want to check blood chemistry, including potassium levels, while you are on this drug.

• SERIOUS ALLERGIC REACTION: Celebrex is a sulfonamide (sulfa drug) and NSAID. There are reports of serious allergic reactions, including anaphylactic reactions (throat closing) in patients who received Celebrex (celecoxib). The risk is higher in people with aspirin-sensitive asthma. 

  Tell your doctor if you have a history of allergy to sulfa drugs or aspirin. Both NSAIDs and sulfonamides can cause life-threatening anaphylactic reactions as well as less severe asthmatic episodes in certain people. Seek emergency medical care if you develop signs and symptoms of an anaphylactic reaction such as throat tightening, shortness of breath, or difficulty breathing. 

• WORSENING ASTHMA RELATED TO ASPIRIN SENSITIVITY: People with aspirin-sensitive asthma or chronic rhinosinusitis (frequent runny or stuffy nose) or nasal polyps can develop severe, potentially fatal bronchospasm (narrowing of the airways) upon exposure to aspirin. Because aspirin and NSAIDs like Celebrex (celecoxib) have cross-reactivity, Celebrex is contraindicated in people with aspirin sensitivity. Tell your doctor if you have asthma (with or without aspirin sensitivity). Seek immediate medical care for any changes in your asthma symptoms or trouble breathing. 

• SERIOUS SKIN REACTIONS: Serious skin reactions have been reported in people treated with Celebrex, including toxic epidermal necrolysis (TEN), Stevens-Johnson Syndrome (SJS), exfoliative dermatitis, erythema multiforme, acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS). These serious drug reactions can be fatal. 

  Stop taking Celebrex and seek immediate medical care if you develop a severe skin reaction (rash, hives, itching, blistering). Other symptoms of a severe drug reaction can include fever, facial swelling, enlarged lymph nodes, flu-like symptoms, muscle pain, unusual bleeding or bruising, and urinary symptoms. Do not take Celebrex again if you have had a severe skin reaction to it in the past.

• FETAL TOXICITY: Use of Celebrex and other NSAIDs in pregnancy can cause serious problems in the unborn baby, including premature closure of fetal ductus arteriosus (a heart abnormality). Celebrex use can also lead to kidney problems, delayed lung maturation, and skeletal problems in the baby due to oligohydramnios (decreased amniotic fluid). 

  Due to these risks, your obstetrician will recommend against taking Celebrex after 20 weeks gestation (second and third trimesters). If you must take NSAIDs while you’re pregnant, your healthcare providers will prescribe the lowest dose for the shortest time and monitor you carefully.

• HEMATOLOGICAL TOXICITY: There are reports of anemia in patients treated with NSAIDs. This could be due to occult (hidden) or gross blood loss from bleeding, fluid retention, or a direct effect of the drug on erythropoiesis (red cell formation). 

  Seek immediate medical care if you develop signs of anemia, such as pale skin, unusual tiredness, or low energy. Keep all your medical and lab appointments while on this drug. Your doctor may want to check hemoglobin and hematocrit.

  Tell your doctor if you have a history of coagulopathies (blood clotting disorders) or bleeding events. Also, tell your doctor if you take anticoagulants (blood thinners) such as warfarin, antiplatelet drugs like aspirin, selective serotonin reuptake inhibitors (SSRIs), or serotonin-norepinephrine reuptake inhibitors (SNRIs). Concomitant use of these medicines with Celebrex can increase the risk of bleeding. 

• MASKED SYMPTOMS OF INFLAMMATION: Celebrex can mask symptoms of inflammation and fever, which could potentially delay diagnosis of infections. Take Celebrex exactly as prescribed. Do not continue taking this medicine for longer than advised by your doctor. 

• LABORATORY TESTING: Your healthcare provider will order periodic laboratory tests to identify adverse effects such as serious GI bleeding, anemia, liver toxicity, or kidney injury, which can occur without warning symptoms in patients taking Celebrex. Keep all your healthcare appointments while on this drug. 

• DISSEMINATED INTRAVASCULAR COAGULATION (DIC): There is a risk of disseminated intravascular coagulation (DIC) in children treated with Celebrex for juvenile rheumatoid arthritis. DIC is a rare but serious blood clotting disorder. Your child’s doctor will monitor carefully for signs and symptoms of abnormal clotting or bleeding. Seek immediate medical care if your child is taking Celebrex and develops unusual bruising or bleeding, low blood pressure, unusual tiredness, confusion, fever, or shortness of breath.