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Ethiodized Oil

[03 June 2015]

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 Jubliant 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

Imported Product
Lipiodol Ultra-Fluide, Guerbet
10 mL ampule (Product 3400930621608)

Estimated Resupply Dates

  • Guerbet estimates they will begin shipping supplies of Lipiodol Ultra-Fluide by early July when all supplies of Lipiodol are depleted.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.5,6,7

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

Related Shortages

References

  1. Guerbet. Personal communication. June 3, 2015.
  2. Guerbet. Dear Healthcare Professional Letter. June 1, 2015. 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: 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

Created June 3, 2015 by Erin R. Fox, PharmD, Director, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.

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