FDA Black Box Warning for NSAIDs
All NSAIDs carry FDA black box warnings for BOTH serious cardiovascular thrombotic events (including myocardial infarction and stroke) AND life-threatening gastrointestinal adverse events (including bleeding, ulceration, and perforation), which can be fatal. 1
The Dual Black Box Warning
The FDA mandates that all NSAID package inserts contain warnings for two distinct life-threatening risks:
Cardiovascular Risk
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal 1
- This risk may increase with duration of use 1
- Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk 1
- All NSAIDs are contraindicated for treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery 1
Gastrointestinal Risk
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal 1
- These events can occur at any time during use and without warning symptoms 1
- Elderly patients are at greater risk for serious gastrointestinal events 1
Clinical Context
Both traditional NSAIDs (like diclofenac, ibuprofen, naproxen) and COX-2 selective inhibitors (like celecoxib) carry these dual black box warnings 1. The warnings emphasize that GI bleeding can occur without warning symptoms, making it particularly dangerous 1. The American Heart Association notes that nonselective COX inhibition provides effective pain relief but carries risk for erosive gastritis and GI bleeding 1.
Answer to the multiple choice question: "Potential for causing life-threatening gastrointestinal (GI) bleeds" is correct, though the complete FDA black box warning actually includes both GI and cardiovascular risks. 1