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Should the FDA Approve Omegaven?

Lomangino, Kevin

doi: 10.1097/01.NMD.0000433492.53554.1c
Articles
KEY MESSAGES 
  • Many clinicians believe that compassionate use restrictions on Omegaven, a fish oil-based lipid emulsion, place an unnecessary burden on families, and that the product should be approved for the treatment of intestinal failure-associated liver disease based on studies involving open-label data and comparison with historical controls.
  • Other clinicians say that current restrictions are appropriate, and that Omegaven should be tested in randomized trials with contemporary controls to prove its efficacy and safety.

Mr. Lomangino has disclosed that he is a consultant to the Informed Medical Decisions Foundation and the American Association of Diabetes Educators.

Mr. Lomangino has disclosed that Omegaven is not approved by the FDA for the treatment of intestinal failure-associated liver disease.

© 2013 by Lippincott Williams & Wilkins, Inc.
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