FDA warns providers after 2 patients die from ultrasound contrast-agent reactions
The U.S. Food and Drug Administration warned imaging providers Thursday following recent allergic reactions to certain ultrasound contrast agents, including two deaths.
Its alert includes Definity and its room temperature formulation, both from Lantheus, along with Bracco’s Lumason. The drugs contain polyethylene glycol, and providers should not administer them to patients with known or suspected allergies to this compound, which is derived from petroleum.
“FDA is aware of immediate hypersensitivity reactions, including 11 cases of anaphylaxis and 2 deaths, that appear related to the administration of either Definity or Lumason among patients with a reported history of PEG allergy,” the administration said in an update issued April 22.
The agency has now added a warning for PEG sensitivity to the prescribing information for these drugs. This action follows a review of scientific literature, the drug sponsors’ safety analyses, and reports submitted to the FDA Adverse Event Reporting System.
Since some patients may be unaware of an allergy to polyethylene glycol, providers should inquire about previous reactions to other PEG-containing products. Those may include certain colonoscopy bowel preparations and laxatives. Also, cardiopulmonary resuscitation personnel and equipment should be at-the-ready prior to administrating these contrast agents, the FDA noted. And all patients must be monitored for hypersensitivity.
“As part of FDA’s routine monitoring, we will continue to monitor ultrasound contrast agents for safety issues and will take appropriate action to protect public health,” the alert concluded.
The American College of Radiology alerted its members about the issue on Thursday afternoon.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.