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Clinical Trials Experience

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 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.

Table 2 : 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)
*Incidence of events 3% - 10%

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 infarction

Metabolic and Nutrition Increased creatinine phosphokinase

Musculoskeletal System Myalgia

Skin and Appendages Pruritus

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of SUPRANE. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Coagulopathy

Metabolism and Nutrition Disorders: Hyperkalemia, Hypokalemia, metabolic acidosis

Nervous System Disorders: Convulsion

Eye Disorders: Ocular icterus

Cardiac Disorders: Cardiac arrest, Torsade de pointes, ventricular failure, ventricular hypokinesia, atrial fibrillation

Vascular Disorders: Malignant hypertension, hemorrhage, hypotension, shock

Respiratory, Thoracic and Mediastinal Disorders: Respiratory arrest, respiratory failure, respiratory distress, bronchospasm, hemoptysis

Gastrointestinal Disorders: Pancreatitis acute, abdominal pain

Hepatobiliary Disorders: Hepatic failure, hepatic necrosis, hepatitis, cytolytic hepatitis, cholestasis, jaundice, hepatic function abnormal, liver disorder

Skin and Subcutaneous Tissue Disorder: Urticaria, erythema

Musculoskeletal, Connective Tissue and Bone Disorders: Rhabdomyolysis

General Disorders and Administration Site Conditions: Hyperthermia malignant, asthenia, malaise

Investigations: Electrocardiogram ST-T change, electrocardiogram T-wave inversion, tranaminases increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, coagulation test abnormal, ammonia increased

Injury, Poisoning, and Procedural Complications*: Tachyarrhythmia, palpitations, eye burns, blindness transient, encephalopathy, ulcerative keratitis, ocular hyperemia, visual acuity reduced, eye irritation, eye pain, dizziness, migraine, fatigue, accidental exposure, skin burning sensation, drug administration error

*All of reactions categorized within this SOC were accidental exposures to non-patients.