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A US Food & Drug Administration (FDA) Drug Safety Communication concerning a New Class Warning for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) has been released. Gadolinium has been found to remain in patients’ bodies, including the brain, for months to years.1
The FDA concluded that the benefit of all approved GBCAs outweighs any potential risks because gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function. To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis that occurs in a small subgroup of patients with preexisting kidney failure. However, the FDA has recently received reports of adverse events involving multiple organ systems in patients with normal kidney function.1
After a review by the Medical Imaging Drugs Advisory Committee, the FDA is requiring several actions1:
- the development of a new Patient Medication Guide for GBCAs
- a requirement that every patient must read educational information before receiving a GBCA
- manufacturers of GBCAs must conduct human and animal studies to further assess the safety of these contrast agents.
FDA recommendations for your practice
The FDA advises that health care professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who might be of higher risk for gadolinium retention.1,2 These patients include1:
- those requiring multiple lifetime doses
- pregnant women
- children
- patients with inflammatory conditions.
There are 2 types of GBCAs based on chemical structure: linear and macrocyclic. Linear GBCAs result in more retention and retention for a longer time than macrocyclic GBCAs.2 A list of FDA-approved GBCAs with their chemical structures is found here: https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm.2
Recommendations also state that repeated GBCA imaging studies be minimized when possible, particularly closely spaced MRI studies. However, necessary GBCA MRI scans should not be avoided or deferred.1
Report adverse effects
Health care professionals and patients are encouraged to report adverse effects or side effects related to the use of GBCAs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program found here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.
- US Food & Drug Administration. Safety: Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm589580.htm. Published December 19, 2017. Accessed January 10, 2018.
- US Food & Drug Administration. Drugs: FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warning. https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm. Published December 19, 2017. Accessed January 10, 2018.
A US Food & Drug Administration (FDA) Drug Safety Communication concerning a New Class Warning for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) has been released. Gadolinium has been found to remain in patients’ bodies, including the brain, for months to years.1
The FDA concluded that the benefit of all approved GBCAs outweighs any potential risks because gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function. To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis that occurs in a small subgroup of patients with preexisting kidney failure. However, the FDA has recently received reports of adverse events involving multiple organ systems in patients with normal kidney function.1
After a review by the Medical Imaging Drugs Advisory Committee, the FDA is requiring several actions1:
- the development of a new Patient Medication Guide for GBCAs
- a requirement that every patient must read educational information before receiving a GBCA
- manufacturers of GBCAs must conduct human and animal studies to further assess the safety of these contrast agents.
FDA recommendations for your practice
The FDA advises that health care professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who might be of higher risk for gadolinium retention.1,2 These patients include1:
- those requiring multiple lifetime doses
- pregnant women
- children
- patients with inflammatory conditions.
There are 2 types of GBCAs based on chemical structure: linear and macrocyclic. Linear GBCAs result in more retention and retention for a longer time than macrocyclic GBCAs.2 A list of FDA-approved GBCAs with their chemical structures is found here: https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm.2
Recommendations also state that repeated GBCA imaging studies be minimized when possible, particularly closely spaced MRI studies. However, necessary GBCA MRI scans should not be avoided or deferred.1
Report adverse effects
Health care professionals and patients are encouraged to report adverse effects or side effects related to the use of GBCAs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program found here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.
A US Food & Drug Administration (FDA) Drug Safety Communication concerning a New Class Warning for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) has been released. Gadolinium has been found to remain in patients’ bodies, including the brain, for months to years.1
The FDA concluded that the benefit of all approved GBCAs outweighs any potential risks because gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function. To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis that occurs in a small subgroup of patients with preexisting kidney failure. However, the FDA has recently received reports of adverse events involving multiple organ systems in patients with normal kidney function.1
After a review by the Medical Imaging Drugs Advisory Committee, the FDA is requiring several actions1:
- the development of a new Patient Medication Guide for GBCAs
- a requirement that every patient must read educational information before receiving a GBCA
- manufacturers of GBCAs must conduct human and animal studies to further assess the safety of these contrast agents.
FDA recommendations for your practice
The FDA advises that health care professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who might be of higher risk for gadolinium retention.1,2 These patients include1:
- those requiring multiple lifetime doses
- pregnant women
- children
- patients with inflammatory conditions.
There are 2 types of GBCAs based on chemical structure: linear and macrocyclic. Linear GBCAs result in more retention and retention for a longer time than macrocyclic GBCAs.2 A list of FDA-approved GBCAs with their chemical structures is found here: https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm.2
Recommendations also state that repeated GBCA imaging studies be minimized when possible, particularly closely spaced MRI studies. However, necessary GBCA MRI scans should not be avoided or deferred.1
Report adverse effects
Health care professionals and patients are encouraged to report adverse effects or side effects related to the use of GBCAs to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program found here: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.
- US Food & Drug Administration. Safety: Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm589580.htm. Published December 19, 2017. Accessed January 10, 2018.
- US Food & Drug Administration. Drugs: FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warning. https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm. Published December 19, 2017. Accessed January 10, 2018.
- US Food & Drug Administration. Safety: Gadolinium-based Contrast Agents (GBCAs): Drug Safety Communication - Retained in Body; New Class Warnings. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm589580.htm. Published December 19, 2017. Accessed January 10, 2018.
- US Food & Drug Administration. Drugs: FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warning. https://www.fda.gov/Drugs/DrugSafety/ucm589213.htm. Published December 19, 2017. Accessed January 10, 2018.