ADVERSE REACTIONS
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 (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.
Table 2
Frequency of Events Occurring in Greater Than 1% of Clinical Trial Patients (in Reports Deemed “Probably Causally Related”)
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Induction (use as a mask inhalation agent)
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Adult Patients (N=370):
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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) |
Frequency of Events Occurring in Less Than 1% of Patients (in Reports Deemed “Probably Causally Related”)
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Reported in 3 or more patients, regardless of severity
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Adverse reactions reported only from postmarketing experience or in the literature, not seen in clinical trials, are considered rare and are italicized.
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Cardiovascular
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Arrhythmia, bigeminy, abnormal electrocardiogram, myocardial ischemia, vasodilation |
Digestive
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Hepatitis
|
Nervous System
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Agitation, dizziness |
Respiratory
|
Asthma, dyspnea, hypoxia |
Frequency of Events Occurring in Less Than 1% of Clinical Trial Patients (in Reports Deemed “Causal Relationship Unknown”)
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Reported in 3 or more patients, regardless of severity
|
Body as a Whole
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Fever |
Cardiovascular
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Hemorrhage, myocardial infarction |
Metabolic and Nutrition
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Increased creatinine phosphokinase |
Musculoskeletal System
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Myalgia |
Skin and Appendages
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Pruritus |
Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of SUPRANE (desflurane, USP). 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.
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REPORTS OF SUSPECTED SUPRANE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Suprane. The information is not vetted and should not be considered as verified clinical evidence.
Possible Suprane side effects / adverse reactions in 63 year old female
Reported by a physician from Japan on 2011-10-05
Patient: 63 year old female weighing 55.0 kg (121.0 pounds)
Reactions: NO Therapeutic Response, Anaphylactic Shock, Latex Allergy
Suspect drug(s):
Suprane
Indication: Maintenance of Anaesthesia
Start date: 2011-08-24
End date: 2011-08-24
Propofol
Indication: Induction of Anaesthesia
Start date: 2011-08-24
End date: 2011-08-24
Rocuronium Bromide
Indication: Hypotonia
Start date: 2011-08-24
End date: 2011-08-24
Popscaine
Indication: Epidural Anaesthesia
Start date: 2011-08-24
End date: 2011-08-24
Sevoflurane
Start date: 2011-08-24
End date: 2011-08-24
Sevoflurane
Indication: Maintenance of Anaesthesia
Start date: 2011-08-24
End date: 2011-08-24
Ceftriaxone Sodium
Indication: Infection Prophylaxis
Start date: 2011-08-24
End date: 2011-08-24
Possible Suprane side effects / adverse reactions in 62 year old male
Reported by a health professional (non-physician/pharmacist) from Greece on 2011-10-27
Patient: 62 year old male weighing 82.0 kg (180.4 pounds)
Reactions: Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Pulmonary Granuloma
Adverse event resulted in: death
Suspect drug(s):
Metoclopramide
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Atropine
Indication: Neuromuscular Blockade Reversal
Start date: 2011-10-04
End date: 2011-10-04
Acetaminophen
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Neostigmine
Indication: Neuromuscular Blockade Reversal
Start date: 2011-10-04
End date: 2011-10-04
Lactated Ringer's
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Naropin
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Naropin
Start date: 2011-10-04
End date: 2011-10-04
Naropin
Start date: 2011-10-04
End date: 2011-10-04
Cisatracurium Besylate
Indication: Hypotonia
Start date: 2011-10-04
End date: 2011-10-04
Sodium Chloride 0.9% IN Plastic Container
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Morphine
Start date: 2011-10-04
End date: 2011-10-04
Remifentanil
Indication: Analgesic Therapy
Start date: 2011-10-04
End date: 2011-10-04
Ranitidine
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Morphine
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Suprane
Indication: Maintenance of Anaesthesia
Start date: 2011-10-04
End date: 2011-10-04
Ondasetron
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Other drugs received by patient: Fentanyl-100; Propofol
Possible Suprane side effects / adverse reactions in 67 year old male
Reported by a health professional (non-physician/pharmacist) from Greece on 2011-10-27
Patient: 67 year old male weighing 70.0 kg (154.0 pounds)
Reactions: Chylothorax, Sepsis, Acute Respiratory Distress Syndrome, Acute Respiratory Failure, Pulmonary Granuloma
Adverse event resulted in: death
Suspect drug(s):
Metoclopramide
Indication: Product Used FOR Unknown Indication
Cisatracurium Besylate
Indication: Product Used FOR Unknown Indication
Neostigmine
Indication: Product Used FOR Unknown Indication
Remifentanil
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-04
End date: 2011-10-04
Acetaminophen
Indication: Product Used FOR Unknown Indication
Atropine
Indication: Product Used FOR Unknown Indication
Suprane
Indication: Maintenance of Anaesthesia
Start date: 2011-10-04
Morphine
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Fentanyl-100; Propofol
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