Xenical (orlistat) Capsules, 120 mg February 2009

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. Read about the new physician labeling format.

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