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U.S. Department of Health and Human Services

Safety

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Letairis (ambrisentan) Tablets


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2008

 

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 Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Fluid Retention

ADVERSE REACTIONS

  • Postmarketing Experience
    • Fluid Retention

MEDICATION GUIDE

  • The most common side effects of Letairis
    • Swelling of hands, legs, ankles and feet (peripheral edema)...

WARNINGS AND PRECAUTIONS

Fluid Retention

Peripheral edema is a known class effect of endothelin receptor antagonists, and is also a clinical consequence of PAH and worsening PAH. In the placebo-controlled studies, there was an increased incidence of peripheral edema in patients treated with doses of 5 or 10 mg Letairis compared to placebo [see Adverse Reactions (6)]. Most edema was mild to moderate in severity, and it occurred with greater frequency and severity in elderly patients...
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