Abstract Archives of the RSNA, 2006
Andrew Gabriel Bleicher MD, Presenter: Nothing to Disclose
Emanuel Kanal MD, Abstract Co-Author: Consultant, General Electric Company
Speakers Bureau, General Electric Company
Consultant, Bracco Group
Speakers Bureau, Bracco Group
Consultant, Siemens AG
Speakers Bureau, Siemens AG
Consultant, Medtronic, Inc
Speakers Bureau, Medtronic, Inc
Research grant, Bracco Group
Research grant, Schering AG (Berlex Inc)
With the introduction of a newly approved high relaxivity MR contrast agent across a health care system encompassing several hospitals and imaging centers, there was concern as to the actual adverse reaction rate that would be experienced with this new agent. Data were collected prospectively to assess the relative risk of Multihance compared with that of published data for other approved Gadolinium based MR contrast agents.
It was prospectively established that as part of the quality assurance procedures associated with this new agent, MR technologists and nurses were to record all contrast related adverse reactions. Data to be recorded included the type of reaction and treatments provided. These data have been collated at each site by a designated party. All data are reviewed weekly by the institutional director of MR services.
Over the past seven months, 22663 MR examinations have been performed in the four sites that are participating in this evaluation. There have been 9103 administrations of Multihance and 68 reported cases of adverse reaction of any type. This represents a 0.75% reaction rate. Types of reactions included nausea (31), emesis (18), hives/ anaphylactoid reaction (15), gagging (2), tingling (1), chest pain (1), and shortness of breath (1). Of these, two patients were sent to the Emergency Department. One was observed and released without treatment. Two were admitted to the hospital, one for unrelated symptoms. Bother were discharged the next day. Six patients were treated with Benadryl and discharged home from the Radiology department after extended observation. The remaining patients improved without treatment.
Prospectively studied adverse reaction rates involving the recently FDA-approved Multihance contrast agent are essentially interchangeable with those observed with the older FDA-approved Gadolinium-based MR contrast agents.
Prospectively assessed adverse reaction rates for Multihance at four institutions with busy private and academic practices meet or exceed those documented for the lower relaxivity MR contrast agents.
Bleicher, A,
Kanal, E,
Hot Topic: A Reduced Rate of Adverse Reactions with the System-wide Introduction of a New MRI Contrast Agent. Radiological Society of North America 2006 Scientific Assembly and Annual Meeting, November 26 - December 1, 2006 ,Chicago IL.
http://archive.rsna.org/2006/4426682.html