SonoVue® (sulphur hexafluoride) and anaphylactic reactions
SonoVue® (sulphur hexafluoride) and anaphylactic reactions
Due to a current PV case report, Swissmedic would like to issue a reminder of a known adverse drug reaction in connection with the echocardiographic contrast agent SonoVue®.
The product is only used for diagnostic purposes and comprises microbubbles of the active substance sulphur hexafluoride. SonoVue® is intended for use in ultrasonography to increase the echogenicity of the blood or of fluids in the urinary tract. Its indications include echocardiography, doppler of the macro- and microvasculature, and ultrasonography of the excretory urinary tract.
Serious hypersensitivity reactions have been observed in patients without prior exposure during or shortly after the use of SonoVue®.
SonoVue, anaphylactic reaction, shock, hypersensitivity, diagnostics, macrogol, sulphur hexafluoride, vasovagal reaction
Incident data |
Description |
Case (year): 2024 Age group: Elderly patients Sex: Female Medicinal product: SonoVue® Active substance: Sulphur hexafluoride Indication: CEUS (contrast-enhanced ultrasound) of the liver ADRs: Anaphylactic shock Outcome: Recovered |
During a contrast-enhanced ultrasound (CEUS) of the liver, the patient exhibited anaphylactic shock with rash, diffuse feeling of heat and hypotonia (70/40 mmHg) 30 seconds after administration of SonoVue®. The patient received immediate standard emergency treatment and was transferred to a hospital. He was discharged two days later in good general health. The subsequent BAT (basophil activation test) revealed sensitisation to SonoVue®. |
Summary and recommendation
Hypersensitivity reactions (frequency: rare, corresponding to 1/10,000, ≥ 1/1,000), anaphylaxis and vasovagal reactions (frequency: unknown) are listed as adverse drug reactions in the information for healthcare professionals for SonoVue®. It is recommended that all patients are kept under close observation by a doctor for at least 30 minutes after administering SonoVue® to monitor the risk of serious reactions.
Extreme caution should be exercised when SonoVue® is administered in patients at increased risk of cardiac complications. These include patients with recent acute coronary syndrome, acute heart failure or clinically unstable ischaemic heart disease.
Allergy-like and/or vasodilatory reactions may lead to life-threatening conditions in these patients. SonoVue® should only be used in these cases after carefully weighing up the benefits and risks, and under close observation of vital functions and ECG during and after use. In very rare cases, fatal reactions have been reported shortly after administering SonoVue®. Most of these patients had a high baseline risk of severe cardiac complications, to which the fatal outcome could be attributed.
Statutory duty of healthcare professionals to report adverse drug reactions (ADRs)
In Switzerland, healthcare professionals who are authorised to dispense or administer medicinal products are obligated to report severe and/or previously unknown side effects. Reports to Swissmedic can be entered and sent in the Electronic Vigilance Reporting Portal “ElViS” (ElViS login).
Supplementary information
SonoVue 8 μL/mL
Information for healthcare professionals
(www.swissmedicinfo.ch)
