Lawsuits Are Being Filed Concerning Fatal Allergic Reactions Link to Ultrasound Contrast Affinity Containing Polyethylene Glycol (PEG)
FDA – The United States Food and Drug Administration has announced a new warning regarding Difinity and Difinity RT which contain polyethylene glycol (PEG) that has cause fatal allergic reactions. The FDA issued a new warning letter to ultrasound imaging technicians, doctors, healthcare providers, and all other providers that there have been reports of anaphylaxis the deaths link to several ultrasound contrast agents.
According to the FDA, ultrasound contrast agents such as Definity, Definity RT, Lumason, and Bracco‘s Lumason contain a chemical called poly ethylene glycol (PEG). Polyethylene glycol is a polyether compound manufactured from petroleum. Some patients have sustained immediate hypersensitivity or severe allergic reactions causing anaphylaxis and death. According to the FDA’s letter, it is aware of several adverse reports of acute anaphylaxis. In the FDA’s warning letter to healthcare providers, the agency has reported that at least two ultrasound patients have died after being administered and ultrasound contrast containing polyethylene glycol (PEG).
The FDA is cautioning healthcare providers Who use ultrasound devices two use caution when administering to Definity, to Definity RT, Lumason, or Bracco‘s Lumason to ultrasound patients who may be allergic or have a known allergy to polyethylene glycol or history of hypersensitivity two the contrast agent. The FDA mandates that all products containing polyethylene glycol receive an update to product labeling and instructions that list the risk of anaphylaxis or death due to allergy or hypersensitivity to PED. Moreover, the FDA will require new contra indications to be added to the prescribing information for Ultrasound contrasts: Definity, Definity RT, Lumason, and Bracco’s Lumason.
Ultrasound technicians and other ultrasound Healthcare providers are being urged by the FDA to review their patient’s medical history to confirm whether or not their patients have a history of polyethylene glycol hypersensitivity or allergies. The FDA reminds the health care providers that their patients may not be aware that they have a sensitivity or allergy to polyethylene glycol.
Ultrasound professionals are being asked to discuss the risk of polyethylene glycol hypersensitivity or allergic reactions with their patients. The FDA recommends asking their patients if they have an allergy to common PEG-containing products such as laxatives or colonoscopy bowel preparations. Moreover, the FDA is urging ultrasound clinics to have Advanced Cardiovascular Life Support (ACLS) equipment ready before administrating an ultrasound contrast agent and to observe their patients for signs of a hypersensitivity reaction when using an ultrasound contrast agent that contains polyethylene glycol (PEG).
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