6.1 Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Clinical Trials of Cisatracurium Besylate Injection in Surgical Patients
The data presented below are based on studies involving 945 surgical patients who received cisatracurium besylate in conjunction with other drugs in US and European clinical studies in a variety of procedures [see Clinical Studies (14.1)].
Table 3 displays adverse reactions that occurred at a rate of less than 1%.
Table 3. Adverse Reactions in Clinical Trials of Cisatracurium Besylate Injection in Surgical Patients| Adverse Reaction | Incidence |
|---|
Bradycardia | 0.4% |
Hypotension | 0.2% |
Flushing | 0.2% |
Bronchospasm | 0.2% |
Rash | 0.1% |
Adverse Reactions in Clinical Trials of Cisatracurium Besylate Injection in Intensive Care Unit Patients
The adverse reactions presented below were from studies involving 68 adult ICU patients who received cisatracurium besylate in conjunction with other drugs in US and European clinical studies [see Clinical Studies (14.3)]. One patient experienced bronchospasm. In one of the two ICU studies, a randomized and double-blind study of ICU patients using TOF neuromuscular monitoring, there were two reports of prolonged recovery (range: 167 and 270 minutes) among 28 patients administered cisatracurium besylate and 13 reports of prolonged recovery (range: 90 minutes to 33 hours) among 30 patients administered vecuronium.
6.2 Postmarketing Experience
The following events have been identified during post-approval use of cisatracurium besylate in conjunction with one or more anesthetic agents in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to cisatracurium besylate: anaphylaxis, histamine release, prolonged neuromuscular block, muscle weakness, myopathy.