ADVERSE EVENTS
In controlled and open label clinical studies with DepoDur, the majority of the adverse events were typical of opiate medications and would be expected in the surgical populations studied. The most common adverse events (greater than 10%) reported at least once during therapy in patients treated with DepoDur were decreased oxygen saturation, hypotension, urinary retention, vomiting, constipation, nausea, pruritus, pyrexia, anemia, headache, and dizziness. Adverse events occurring in 5–10% of study patients were hypoxia, tachycardia, insomnia, and flatulence. Other less common side effects (seen in 2–5% of patients receiving DepoDur) included respiratory depression, hypercapnia, paralytic ileus, somnolence, bladder spasm, abdominal distension, hypoesthesia, hypertension, oliguria, bradycardia, anxiety, back pain, increased sweating, dyspepsia, rigors, dyspnea, hypokalemia, paresthesia, and decreased hematocrit.
Of the patients treated with DepoDur in clinical trials, 4% exhibited signs of respiratory depression requiring treatment with narcotic antagonists. In clinical trials, 90% of respiratory depression occurred within 24 hours after administration of DepoDur. However, onset of respiratory depression occurred in 0.6% of patients after more than 48 hours.
During post-marketing experience, central nervous system (CNS) depression, including obtunded feeling, non-arousable condition, unresponsiveness, confusion, and lethargy, has been reported following epidural administration of DepoDur. In most of these cases with CNS depression, there was concomitant administration of different narcotics or hypnotic/sedative medications in the post-operative period.
During post-marketing experience, severe respiratory depression, involving apnea or respiratory arrest, and cardiac arrest have been reported following administration of labeled doses of DepoDur.
Prolonged respiratory depression or apnea may occur when administration of epidural DepoDur is associated with subarachnoid puncture.
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