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Suprane (Desflurane) - Side Effects and Adverse Reactions

 
 



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”)

Induction (use as a mask inhalation agent)

Adult Patients (N=370):

Coughing 34%, breathholding 30%, apnea 15%, increased secretions 1, 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)

1 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 (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.



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



See index of all Suprane side effect reports >>

Drug label data at the top of this Page last updated: 2014-01-24

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