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Jamie Sheller
Jamie Sheller
Attorney • (800) 883-2299

Micro-bubble contrast agents may cause death or serious cardiapulmonary reactions

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Reports of death and serious cardiopulmonary reactions to the micro-bubble contrast agents used with ultrasounds has caused the FDA to require revisions to the labels of these products. Micro-bubble ultrasound contrast agents are used in the administration of ultrasounds to view the heart. Definity and Optison are the only micro-bubble products approved for use in the USA. The adverse reactions to these products occured within 30 minutes to one hour of the administration. The FDA now recommends that physicians assess all patients for the presence of certain heart conditions that may attribute to an adverse reaction. In addition, the FDA recommends that patients inform their doctor if they have certain heart or lung conditions prior to administering the micro-bubble product. For more information, view the following website:

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.