Label Changes for:
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg
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)
5 WARNINGS AND PRECAUTIONS
5.8 Coexisting Conditions section
- added ..... aneurism and pheochromocytoma’
6 ADVERSE REACTIONS
6.3 Postmarketing Experience
- added ..... cardiac arrhythmias
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
- 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.
MEDICATION GUIDE (REMS)
- ... information about the risk of serious asthma outcomes (asthma related death, intubations, and hospitalization) ...