Label Changes for:

Xenical (orlistat) Capsules, 120 mg

February 2009

Changes have been made to the PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

Sections Modified

PRECAUTIONS

  • Drug Interactions
    • Levothyroxine
      • Hypothyroidism has been reported in patients treated concomitantly with orlistat and levothyroxine.....

ADVERSE REACTIONS

  • Other Clinical Studies or Postmarketing
    Surveillance
    • Hypothyroidism has been reported in patients treated concomitantly with orlistat and
      levothyroxine.

PATIENT PACKAGE INSERT

  • What should I tell my doctor before taking XENICAL?
    • make sure your doctor knows if you are taking thyroid medicine....
  • Can I take XENICAL while taking other medications?
    • ..... XENICAL and levothyroxine should be taken at least 4 hours apart
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