Black Box Warning
Black Box Warning: Serious, life-threatening, and fatal respiratory depression have been reported. Risk is increased in patients with respiratory risk factors (COPD, sleep apnea), elderly patients, and those on CNS depressants especially opioids.
What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Gabapentin.