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Ethiodized Oil

Last Updated: July 17, 2018
Status: Discontinued

Products Affected - Description
    • Lipiodol injection, Guerbet, 10 mL ampule, NDC 67684-1901-01
Reason for the Shortage
    • Guerbet states their Lipiodol product is in short supply due to manufacturing problems at Jubilant HollisterStier, the manufacturing site in Canada that supplies Lipiodol for Guerbet. The company estimates the shortage will last at least one year.[1-2]
Available Products
    • Lipiodol Ultra-Fluide, Guerbet, 10 mL ampule, Product 3400930621608

Estimated Resupply Dates

    • Guerbet is shipping supplies of Lipiodol Ultra-Fluide.[2] Lipiodol Ultra-Fluide is not FDA approved. In order to prevent a drug shortage, FDA is allowing Guerbet to import Lipiodol Ultra-Fluide, a product manufactured for Guerbet in France by Delpharm Tours.[2]
    • Customers must order Lipiodol Ultra-Fluide directly from Guerbet by calling 1-877-729-6679. Lipiodol Ultra-Fluide is non-refundable and may not be resold.[2]

Implications for Patient Care

    • Ethiodized oil is a lipophilic non-ionic iodinated contrast medium, derived from poppy seed oil.[3] Lipiodol is the only lipophilic non-ionic contrast media approved in the US.[3-4]
    • Ethiodized oil is labeled for use in patients undergoing hysterosalpingography or lymphography and for hepatic intra-arterial use for imaging tumors in patients with hepatocellular carcinoma.[3]
    • Ethiodized oil is also commonly used in chemoembolization procedures for the treatment of primary and secondary hepatic malignancies.[5-7]

Safety

    • Imported Lipiodol Ultra-Fluide has an international barcode that US scanning systems are unlikely to recognize. Ensure barcode scanners do not provide incorrect information.[2]

Alternative Agents & Management

    • Lipiodol and Lipiodol Ultra-Fluide contain the same components (480 mg iodine/mL in ethyl esters of iodized fatty acids of poppy seed oil).[2]
    • Guerbet has detailed information, including photographs of the Lipiodol Ultra-Fluide cartons, available online. http://www.guerbet-us.com/fileadmin/user_upload/usa_home/customer_care_center/documents/June_1__2015_Lipiodol_Guerbet_DHP_Letter.pdf.

References

    1. Guerbet. Personal communication. June 3, July 13, December 16, 2015; February 17, April 26, June 28, September 20, December 12, 2016; March 13, June 20, October 5 and 10, 2017; January 17, April 11, and July 17, 2018.
    2. Guerbet. Dear Healthcare Professional Letter. June 1, 2015. Available online at http://www.guerbet-us.com/fileadmin/user_upload/usa_home/customer_care_center/documents/June_1__2015_Lipiodol_Guerbet_DHP_Letter.pdf. Accessed June 2, 2015.
    3. Lipiodol (ethiodized oil) injection product information. Bloomington, IN: Guerbet, April 2014.
    4. Swanson D, Maywood C. Miscellaneous radiopaque contrast media. II. Hysterosalpingographic contrast media. In: Swanson D, Chilton H, Thrall J, eds. Pharmaceuticals in Medical Imaging. Radiopaque Contrast Media, Radiopharmaceuticals, Enhancement Agents for Magnetic Resonance Imaging and Ultrasound. New York, NY: MacMillan Publishing Co; 1990:227-236.
    5. American College of Radiology. ACR Appropriateness Criteria. Radiologic Management of Hepatic Malignancy, 2011: http://www.acr.org/~/media/ACR/Documents/AppCriteria/Interventional/RadiologicManagementHepaticMalignancy.pdf. Accessed June 2, 2015.
    6. Reidy DL, Schwartz JD. Therapy for unresectable hepatocellular carcinoma: review of the randomized clinical trials-I: hepatic arterial embolization and embolization-based therapies in unresectable hepatocellular carcinoma. Anticancer Drugs. Jun 2004;15(5):427-437.
    7. Brown DB, Geschwind JF, Soulen MC, Millward SF, Sacks D. Society of Interventional Radiology position statement on chemoembolization of hepatic malignancies. J Vasc Interv Radiol. Feb 2006;17(2 Pt 1):217-223.

Updated

Updated July 17, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. Created June 3, 2015 by Erin R. Fox, PharmD, Director, Drug Information Service. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

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