Label Changes for:
Combivent (ipratropium bromide and albuterol sulfate) Inhalation Aerosol
June 2009
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) -- June 2009
WARNINGS
Cardiovascular Effect
- There is some evidence from post-marketing data and published literature of rare occurrences of myocardial ischemia associated with albuterol.
