Label Changes for:

Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg

September 2012

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

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

 

September 2012

5 WARNINGS AND PRECAUTIONS

5.8 Coexisting Conditions section
  • added ..... aneurism and pheochromocytoma’

6 ADVERSE REACTIONS

6.3 Postmarketing Experience
  • added ..... cardiac arrhythmias

DRUG INTERACTIONS

7.4 MAO Inhibitors
  • added ..... macrolides
7.6 Halogenated Hydrocarbons
  • There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons

MEDICATION GUIDE

  • If any of the side effects affects you severely, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. 

 

 

May 2011 

MEDICATION GUIDE (REMS)

  • ... information about the risk of serious asthma outcomes (asthma related death, intubations, and hospitalization) ...

 

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