The safety profiles of the below listed Iodine containing contrast agents have updated as per the new drug safety updates published by Japan Health Authority–Pharmaceuticals and Medical Devices Agency (PMDA).
Iodixanol comes under the therapeutic category of x-ray contrast media which is a hydrophilic iodinated radiocontrast agent used in diagnostic imaging. This compound is most commonly used as a contrast agent during coronary angiography, and for patients with renal dysfunction. This contrasting agent is less nephrotoxic (kidney toxicity) compared to other intravascular contrasting agents.
The following clinically significant safety information is added into Iodixanol’s package insert (Product information document) under precautions and adverse reaction sections.
Contrast-Induced encephalopathy, disturbed consciousness, paralysis, aphasia, cortical blindness, and other central nervous system (CNS) symptoms which might occur as a result of extra cerebrovascular leakage of Iodixanol during cerebral angiography.
This is also an iodine containing contrast agent falling under the therapeutic category of x-ray contrast media which is used in examining blood vessels, organs, and other non-bony tissues more clearly on a CT scan and other radiologic examinations like arteriography, venography, ventriculography, aortography etc., It is used in the diagnosis of certain disorders related to heart, brain, blood vessels, and nervous system.
The following clinically significant safety information is added into Iopamidol’s package insert under precautions and adverse reaction sections.
Contrast-Induced encephalopathy, disturbed consciousness, paralysis, aphasia, cortical blindness, and other central nervous system (CNS) symptoms which might occur as a result of extra cerebrovascular leakage of Iopamidol during cerebral angiography, angiocardiography (including pulmonary artery angiography), and aortography.
Iopromide is a tri-iodinated x-ray contrast agent which is administered by intravascular route and permits radiographic visualization of the internal structures by opacifying vessels.
The following clinically significant safety information is added into Iopromide’s package insert under precautions and adverse reaction sections.
Contrast-Induced encephalopathy, disturbed consciousness, paralysis, aphasia, cortical blindness, and other central nervous system (CNS) symptoms which might occur as a result of extra cerebrovascular leakage of Iopromide during cerebral angiography, thoracic aortography, and angiocardiography.
Iohexol is a tri-iodinated radiographic contrast medium which is indicated for intrathecal administration during myelography (lumbar, thoracic, cervical, total columnar) and in contrast enhancement for CT (myelography, cisternography, ventriculography).
The following clinically significant safety information is added into Iohexol’s package insert under precautions and adverse reaction sections.
Contrast-Induced encephalopathy, disturbed consciousness, paralysis, aphasia, cortical blindness, and other central nervous system (CNS) symptoms which might occur as a result of extra cerebrovascular leakage of Iohexol during cerebral angiography, angiocardiography (including pulmonary artery angiography), aortography, and angiocardiography of pediatrics (including pulmonary artery angiography).
Iomeprol is a tri-iodinated, non-ionic contrast agent falling under the therapeutic category of x-ray contrast medium which is used during peripheral arteriography, aortography, angiocardiography, left ventriculography, coronary arteriography, visceral arteriography, digital subtraction angiography, CT enhancement, urography, dacryocystography, sialography, fistulography and galactography.
The following clinically significant safety information is added into Iomeprol’s package insert under precautions and adverse reaction sections.
Contrast-Induced encephalopathy, disturbed consciousness, paralysis, aphasia, cortical blindness, and other central nervous system (CNS) symptoms which might occur as a result of extra cerebrovascular leakage of Iomeprol during cerebral angiography, thoracic aortography, and angiocardiography
Ioversol is a tri-iodinated compound falling under the therapeutic category of x-ray contrast medium, which is used for peripheral and coronary arteriography, left ventriculography, angiography, angiocardiography, cerebral angiography, venography, and peripheral arteriography.
The following clinically significant safety information is added into Ioversol’s package insert under precautions and adverse reaction sections.
Contrast-Induced encephalopathy, disturbed consciousness, paralysis, aphasia, cortical blindness, and other central nervous system (CNS) symptoms which might occur as a result of extra cerebrovascular leakage of Ioversol during cerebral angiography, angiocardiography, and aortography
Measures to minimize the risk of occurrences of these safety concerns:
- Administration of minimal effective dosages during contrast imaging/cerebral angiography.
- Taking appropriate proactive measures at early stages, if any unusual adverse experiences or abnormalities are observed in patients.
Health care professionals & consumers of pharmaceutical medicinal product(s) are strongly advised to be observe, become aware of the possible unusual experiences or adverse events after administration of medicinal product (s) and report the same to respective national health authority.
This would help in early identification of potential signals and risks of medicinal product which are not yet detected by pharmaceutical companies or regulatory authorities.
Increased reporting of direct adverse event reports from the Public (either from consumers or HCPs) would foster the Pharmacovigilance activities of medicinal products which promotes a better patient safety and public health.