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Celecoxib

Cardiovascular and Gastrointestinal Risks

Cardiovascular Risk

  • Nonsteroidal anti-inflammatory drugs (NSAIDs), including celecoxib, can 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.
  • Celecoxib is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

  • NSAIDs, including celecoxib, can 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.
  • Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, antiplatelet drugs (such as aspirin), anticoagulants; or   selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status. Most postmarketing reports   of fatal GI events occurred in elderly or debilitated patients. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • Perform weekly complete blood cell counts for at least six weeks post dose

FDA and Industry Communications

FDA Public Health Advisory FDA Announces Important Changes and Additional Warnings for COX-2 Selective and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)(April 2005)

FDA Patient Medication Guide

Patient Counseling Information

Medication Guides

Patient Medication Guide

Patient Medication Guide - Elyxyb

Package Inserts

Celecoxib

Additional Information

Updated June 2020