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U.S. Department of Health and Human Services

Safety

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Ventavis (iloprost) Inhalation Solution September 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 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. Read about the new physician labeling format.


Summary View

 

Sections Modified

PRECAUTIONS

  • General
    • Ventavis inhalation can induce bronchospasm, especially in susceptible patients with hyperreactive airways. Ventavis has not been evaluated in patients with chronic obstructive pulmonary disease (COPD), severe asthma, or with acute pulmonary infections. Such patients should be carefully monitored during therapy with Ventavis.

ADVERSE REACTIONS

  • Postmarketing Experience
    • Cases of bronchospasm and wheezing have been reported, particularly in susceptible patients with hyperreactive airways, such as patients with comorbid diseases affecting the airways (see PRECAUTIONS). Cases of epistaxis and gingival bleeding have been reported within one month of starting iloprost treatment. Cases of dizziness and diarrhea have also been reported with the use of Ventavis.