Label Changes for:

Advair HFA (fluticasone propionate and salmeterol) Inhalation Aerosol for Oral Inhalation Only

July 2008

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


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

  • The following additional WARNINGS about Advair HFA should be noted:
    • Pneumonia

MEDICATION GUIDE

  • Who should not use Advair HFA?
    • Do not use Advair HFA:
      • to treat sudden severe symptoms of asthma
      • if you are allergic to any of the ingredients in Advair HFA...
  • What are the possible side effects with Advair HFA?
    • Pneumonia... (added)
    • Common side effects of Advair HFA include upper respiratory tract infection and headache.
  • How should I store Advair HFA?
    • Keep Advair HFA and all medicines out of the reach of children.
  • What are the ingredients in Advair HFA?

WARNINGS: Pneumonia

Lower respiratory tract infections, including pneumonia, have been reported in patients with COPD following the inhaled administration of corticosteroids, including fluticasone propionate and Advair Diskus. In 2 replicate 12-month studies of 1,579 patients with COPD, there was a higher incidence of pneumonia reported in patients receiving Advair Diskus 250/50 (7%) than in those receiving salmeterol 50 mcg (3%). The incidence of pneumonia in the patients treated with Advair Diskus was higher in patients over 65 years of age (9%) compared with the incidence in patients less than 65 years of age (4%).

In a 3-year study of 6,184 patients with COPD, there was a higher incidence of pneumonia reported in patients receiving Advair Diskus 500/50 compared with placebo (16% with Advair Diskus 500/50, 14% with fluticasone propionate 500 mcg, 11% with salmeterol 50 mcg, and 9% with placebo). Similar to what was seen in the 1-year studies with Advair Diskus 250/50, the incidence of pneumonia was higher in patients over 65 years of age (18% with Advair Diskus 500/50 versus 10% with placebo) compared with patients less than 65 years of age (14% with Advair Diskus 500/50 versus 8% with placebo.

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