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U.S. Department of Health and Human Services

Safety

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Juxtapid (Lomitapide) Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

February 2014

Summary View

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
  • Pregnancy Exposure Registry…added

17 PATIENT COUNSELING INFORMATION

  • Phone number added for registry program

MEDICATION GUIDE

2. Harm to your unborn baby.

  • If you become pregnant while taking JUXTAPID, stop taking JUXTAPID and call your doctor right away.
  • Pregnancy Exposure Registry…section added

 

April 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Risk of Hepatotoxicity
Hepatic Steatosis
  • …Juxtapid has not been studied concomitantly with other LDL-lowering agents that can also increase hepatic fat. Therefore, the combined use of such agents is not recommended.