Label Changes for:

Spiriva HandiHaler inhalation powder

March 2009

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

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

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS

ADVERSE REACTIONS

  • added "(new onset or worsening)" to glaucoma

PATIENT PACKAGE INSERT

  • New

WARNINGS

  • section updated symptoms of angioedema: (including swelling of the lips, tongue or throat), itching, and rash
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