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The PRECISION Study

Prospective Randomized Evaluation of Celecoxib
Integrated Safety
vs. Ibuprofen or Naproxen

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use

CELEBREX is contraindicated in the setting of coronary artery bypass graft (CABG) surgery

Gastrointestinal Bleeding, Ulceration, and Perforation

NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events

Contraindications:

  • Known hypersensitivity to celecoxib or any components of the drug product or sulfonamides
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
  • In the setting of CABG surgery

Warnings and Precautions:

  • To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible
  • Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop
  • Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure
  • Heart Failure and Edema: Avoid use of CELEBREX in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure
  • Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of CELEBREX in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function
  • Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs
  • Exacerbation of Asthma Related to Aspirin Sensitivity: CELEBREX is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity)
  • Serious Skin Reactions: Discontinue CELEBREX at first appearance of skin rash or other signs of hypersensitivity Premature Closure of Fetal Ductus Arteriosus: Avoid use in pregnant women starting at 30 weeks of gestation
  • Hematologic Toxicity: Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia

See full Prescribing Information & Boxed Warning for complete Warnings and Precautions

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