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Peterson K, McDonagh M, Thakurta S, et al. Drug Class Review: Nonsteroidal Antiinflammatory Drugs (NSAIDs): Final Update 4 Report [Internet]. Portland (OR): Oregon Health & Science University; 2010 Nov.

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Drug Class Review: Nonsteroidal Antiinflammatory Drugs (NSAIDs)

Drug Class Review: Nonsteroidal Antiinflammatory Drugs (NSAIDs): Final Update 4 Report [Internet].

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Appendix BBlack Box Warnings of Included Drugs

Drug namesBoxed warnings
Celebrex®, Zipsor®, Cataflam®, Nalfon®, Ansaid®, Indocin®, Indocin SR®, Mobic®, Naprosyn®, EC-Naprosyn®, Anaprox®, Anaprox® DS, Naprelan®, Daypro®, Feldene®, Clinoril®, Tolectin® DS, Tolectin® 600, Flector®, Pennsaid®, Ponstel®, Tolectin®, Voltaren®aCardiovascular Risk
  • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (See WARNINGS).
  • These drugs are contraindicated for treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal Risk
  • NSAIDs 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 (See WARNINGS).
Voltaren SR, Voltaren Rapide, Ponstan®, Mobicox®, Naprosyn E®, Naprosyn SR®b
  • Risk of Cardiovascular (CV) Adverse Events: Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV)
    (See WARNINGS AND PRECAUTIONS - Cardiovascular)
  • Non-steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk
  • Caution should be exercised in prescribing NSAIDs to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugax) and/or congestive heart failure (NYHA II-IV)
  • Use of NSAIDs can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure. (see also WARNINGS AND PRECAUTIONS - Renal - Fluid and Electrolyte Balance)
  • Randomized clinical trials with NSAIDs have not been designed to detect differences in cardiovascular events in a chronic setting. Therefore, caution should be exercised when prescribing NSAIDs
  • Risk of Gastrointestinal (GI) Adverse Events (see WARNINGS AND PRECAUTIONS–Gastrointestinal)
  • Use of NSAIDs is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding).
a

Not available in Canada, available in the United States.

b

Available in Canada, not available in the United States.

Copyright © 2010, Oregon Health & Science University.
Bookshelf ID: NBK53952
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