Important New Safety Information about Asthma Medicines
On February 18, 2010, the US Food & Drug Administration (FDA) issued a request to all manufacturers of products containing a long-acting beta2-agonist (LABA), such as SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol. The FDA has proposed class changes to Prescribing Information for asthma, and distributed a communication to health care providers and consumers regarding these proposed changes.
It’s important to note that the FDA does not recommend any change in the use of LABAs for the treatment of COPD.
AstraZeneca is committed to patient safety and the appropriate use of our products. AstraZeneca will work collaboratively with the FDA to update the Prescribing Information for SYMBICORT. The changes are not reflected in our current Prescribing Information and the updated Prescribing Information will be made publicly available once approved by the FDA. For more information on the FDA’s announcement, go to www.fda.gov.
Patients or caregivers should always talk with their health care providers before making any changes in their asthma management plan, or if they have any questions about the appropriate use of SYMBICORT or any other asthma medication.