According to a news report published on Innovate Healthcare Radiology Business, the U.S. Food and Drug Administration issued warnings to healthcare professionals following the tragic death of two patients. The FDA states that the two patients died as a result of an ultrasound contrast-agent allergic reaction. The FDA’s warning was issued to patients and imaging providers and explained that some patients are unknowingly allergic to Polyethylene Glycol (PEG).
According to the FDA’s warning announcement, certain ultrasound contrast agents are made with Polyethylene Glycol (PEG). These ultrasound contrast agents include Lantheus’ Definity and Definity RT, as well as Bracco’s Lumason. The medications have been identified as products containing Polyethylene Glycol, and the FDA wants providers to avoid administering these ultrasound contrast agents to patients with suspected or known or allergies to Polyethylene Glycol.
The FDA stated that the agency is aware of eleven cases of immediate hypersensitivity reactions resulting in anaphylaxis. Two of the patients tragically passed away due to an allergic reaction to PEG. The FDA has also attached a warning for PEG sensitivity to the contract agents’ prescribing information. The FDA’s response comes after incident reports were submitted through the FDA’s Adverse Event Reporting System, a review of scientific literature, the medication sponsors’ safety analyses.
The warning also states that some patients may not know they have an allergy to polyethylene glycol. Therefore, the FDA warned medical providers to ask patients about previous reactions to PEG-containing products such as laxatives and colonoscopy bowel preparations. The FDA’s new warnings also require cardiopulmonary resuscitation equipment and personnel to be ready to respond when administrating these ultrasound contrast agents. The FDA also requires patient monitoring for allergic reactions. The FDA also stated that the agency will review similar products for PEG and will take the appropriate actions to protect public safety.
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