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Isovue-250 FDA Alerts

The FDA Alerts below may be specifically about Isovue-250 or relate to a group or class of drugs which include Isovue-250.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Isovue-250

Drug Safety Communication - FDA Recommends Thyroid Monitoring in Babies and Young Children Who Receive Injections of Iodine-Containing Contrast Media for Medical Imaging

Mar 30, 2022 | Audience:  Pediatrics, Radiology, Health Professional, Patient, Caregiver, Pharmacy

ISSUE: The FDA approved a new warning to the prescribing information for the entire class of iodinated contrast media (ICM) injections and monitoring recommendations for children 3 years or younger. The warning describes the risk of underactive thyroid or a temporary decrease in thyroid hormone levels. These risks and recommendations pertain to ICM given as an injection through an artery or vein.

BACKGROUND: ICM have been approved for decades and are drugs containing iodine given to patients to enhance the ability to see blood vessels, organs, and tissues on medical images such as X-rays or computed tomography scans. This results in detailed images that can help health care professionals diagnose potential problems.

RECOMMENDATIONS:

Parents and caregivers should talk to your child’s health care professional for additional information or if you have any questions or concerns about your child receiving an ICM injection. Babies and young children typically do not show any visible signs of thyroid problems and may need to be monitored by their health care professionals after receiving ICM.

Health care professionals should perform appropriate monitoring of patients from birth through 3 years for the possibility of hypothyroidism or a temporary decrease in thyroid hormone levels following exposure to ICM. Consider evaluating thyroid function within 3 weeks, especially in term and preterm neonates and children with some underlying conditions. If thyroid dysfunction is detected, treat and monitor thyroid function as clinically needed to avoid future cognitive and other developmental disabilities.

Certain pediatric patients are at an increased risk, including those who are newborns or have very low birth weight, prematurity, or the presence of cardiac or other conditions such as those requiring care in neonatal or pediatric intensive care units. Patients with cardiac conditions may be at greatest risk since they often require high doses of contrast during invasive cardiac procedures.

Health care professionals, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Source: FDA

Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants

Nov 17, 2015 | Audience: Radiology, Endocrinology, Patient

ISSUE: FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures. In all of the reported cases, the infants were either premature or had other serious underlying medical conditions. Available evidence leads FDA to believe that this rare occurrence is usually temporary and resolves without treatment or any lasting effects. See the Drug Safety Communication for a data summary and a list of approved Approved Iodinated Contrast Media Products.

FDA approved changes to the labels of all iodinated contrast media (ICM) products to include information about these cases. No changes to current prescribing, administration, or monitoring practices are recommended. FDA will continue to evaluate this issue and will update the public when there is additional information. Manufacturers of ICM products have been required to conduct a study to investigate this safety issue further.

BACKGROUND: Iodinated contrast media are drugs containing iodine that are given to patients to enhance the ability to see blood vessels and organs on medical images such as X-rays or computed tomography (CT) scans. These images provide greater detail when necessary to help health care professionals diagnose potential problems.

RECOMMENDATION: Parents and caregivers should contact their baby’s health care professional for additional information or if they have questions or concerns about their baby receiving an ICM product. Infants typically do not show any visible signs of underactive thyroid. Health care professionals should continue to follow the label recommendations for ICM products. They should continue to use their clinical judgment to determine if testing for underactive thyroid is necessary.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

[11/17/2015 - Drug Safety Communication - FDA]

Isovue (iopamidol injection) Pre-Filled Power Injector Syringes by Bracco Diagnostics Inc.: Recall - Presence of Particulates

Nov 28, 2012 | Audience: Risk Manager, Cardiology

[Posted 11/28/2012]

ISSUE: Bracco Diagnostics Inc. (BDI) is voluntarily initiating a Class I recall of nine (9) lots of Isovue (iopamidol injection) Pre-Filled Power Injector Syringes (Isovue PFS, to be used in combination with Stellant CT Injection Systems) due to the presence of visible particles in syringes observed at the end of standard stability studies on retained samples.These products were distributed to wholesalers and distributors nationwide. BDI has received no reports of adverse events or customer complaints associated with these lots. However, it should be noted that the visible particles in the lots subject to this recall have the potential to cause adverse health consequences. The dates for distribution of the nine (9) affected lots were from January 21, 2010 through May 9, 2012. For a list of products affected see the Firm Press Release.
 

BACKGROUND:  Isovue is indicated for angiography throughout the cardiovascular system, and arterial injection of Isovue (for cerebral angiography) with particulate matter formation could cause stroke.

Isovue PFS is a single use item, administered for diagnostic imaging under medical supervision. The product is packaged in single dose Prefilled Syringe (PFS) presentations of Isovue - 300 FLS2 and Isovue - 370 FLS2.

RECOMMENDATION: Hospitals, Emergency Rooms, Clinics, Physician Offices and other healthcare facilities and providers should not use these lots of Isovue PFS and should immediately quarantine product and contact Stericycle, Bracco’s contractor for handling the recall, at 1-866-201-9133 to arrange for return of the product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

[11/27/12 - Firm Press Release - Bracco Diagnostics]

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