ADVERSE REACTIONS
Adverse event information is derived from controlled clinical trials, the majority of which were conducted in the United States. The studies were conducted using a variety of premedications, other anesthetics, and surgical procedures of varying length. Most adverse events reported were mild and transient, and may reflect the surgical procedures, patient characteristics (including disease) and/or medications administered.
Of the 2,143 patients exposed to SUPRANE (desflurane, USP) in clinical trials, 370 adults and 152 children were induced with desflurane alone and 987 patients were maintained principally with desflurane. The frequencies given reflect the percent of patients with the event. Each patient was counted once for each type of adverse event. They are presented in alphabetical order according to body system.
Frequency of Events Occurring in Greater Than 1% of Clinical Trial Patients (in Reports Deemed “Probably Causally Related”)
Induction (use as a mask inhalation agent)
| ADULT PATIENTS (N=370): | Coughing 34%, breathholding 30%, apnea 15%, increased secretions*, laryngospasm*, oxyhemoglobin desaturation (SpO2< 90%)*, pharyngitis*. |
Maintenance or Recovery
ADULT AND INTUBATED PEDIATRIC PATIENTS (N=687): | Body as a Whole | Headache |
| Cardiovascular | Bradycardia, hypertension, nodal arrhythmia, tachycardia |
| Digestive | Nausea 27%, vomiting 16% |
| Nervous system | Increased salivation |
| Respiratory | Apnea , breathholding, cough increased, laryngospasm, pharyngitis |
| Special Senses | Conjunctivitis& (conjunctival hyperemia) |
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Frequency of Events Occurring in Less Than 1% of Patients (in Reports Deemed “Probably Causally Related”)
Reported in 3 or more patients, regardless of severity
Adverse reactions reported only from postmarketing experience or in the literature, not seen in clinical trials, are considered rare and are italicized.
| Cardiovascular | Arrhythmia, bigeminy abnormal electrocardiogram, myocardial ischemia, vasodilation |
| Digestive | Hepatitis |
| Nervous System | Agitation, dizziness. |
| Respiratory | Asthma, dyspnea, hypoxia |
Frequency of Events Occurring in Less Than 1% of Clinical Trial Patients (in Reports Deemed “Causal Relationship Unknown”)
Reported in 3 or more patients, regardless of severity
| Body as a Whole | Fever |
| Cardiovascular | Hemorrhage, myocardial infarct |
| Metabolic and Nutrition | Increased creatinine phosphokinase |
| Musculoskeletal System | Myalgia |
| Skin and Appendages | Pruritus |
See WARNINGS for information regarding pediatric use and malignant hyperthermia.
SUPRANE (desflurane, USP) has been associated with perioperative hyperkalemia (see WARNINGS).
There have been rare post-marketing reports of hepatic failure and hepatic necrosis associated with the use of potent volatile anesthetic agents, including SUPRANE (desflurane USP). Due to the spontaneous nature of these reports, the actual incidence and relationship of SUPRANE (desflurane USP) to these events cannot be established with certainty.
Laboratory Findings
Transient elevations in glucose and white blood cell count may occur as with use of other anesthetic agents.
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