PLEASE REFER TO THE LETTER BELOW FROM THE AMERICAN COLLEGE OF ALLERGY ASTHMA AND IMMUNOLOGY IN REFERENCE TO SAFETY ISSUES IN REGARDS TO ADVAIR AND SYMBICORT. PLEASE NOTE YOUR PHYSICIANS AND NURSE PRACTIONER ARE WELL INFORMED ABOUT THE ISSUES REGARDING THESE DRUGS. PLEASE DO NOT STOP YOUR MEDICATION WITHOUT CONSULTING YOUR DOCTOR. IF YOU HAVE CONCERNS ABOUT YOU OR YOUR FAMILY MEMBER PLEASE CALL TO MAKE AN APPOINTMENT TO DISCUSS THIS WITH YOUR DOCTOR.
FDA Announces New Restrictions on LABA
The U.S. Food and Drug Administration (FDA) yesterday announced a label change for products for asthma containing long acting Beta2 adrenergic agonist (LABA) drugs to include:
1. The use of LABAs is contraindicated without the use of an asthma controller medication such as inhaled corticosteroid, with the exception of exercise induced asthma.
2. LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
3. LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
AAAAI and ACAAI leadership agree with this proviso: “We recommend considering discussing with patients an action plan for ’step up’ therapy and where appropriate, a ’step down’ approach to treatment.” This may mean a more frequent monitoring of asthma patients requiring these LABAs by specialists.
LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations only apply to the use of LABAs in the treatment of asthma. The FDA is actively seeking to reduce the use of LABA in both children and adults. They will be monitoring the sales of single LABA use and dual therapy before and after this announcement.
For the full release click here FDA Announces New Restictions on LABA.
Here are the source documents:
LABA Information -
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm199565.htm
Q&As -
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm200719.htm
Drug Safety Communication -
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm
Sami L. Bahna, MD, DrPH, FACAAI, FAAAAI
President, American College of
Allergy, Asthma & Immunology
Paul A. Greenberger, MD, FAAAAI, FACAAI
President, American Academy of
Allergy, Asthma & Immunology
FDA Announces New Restrictions on LABA
The U.S. Food and Drug Administration (FDA) yesterday announced a label change for products for asthma containing long acting Beta2 adrenergic agonist (LABA) drugs to include:
1. The use of LABAs is contraindicated without the use of an asthma controller medication such as inhaled corticosteroid, with the exception of exercise induced asthma.
2. LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications.
3. LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved. Patients should then be maintained on an asthma controller medication.
AAAAI and ACAAI leadership agree with this proviso: “We recommend considering discussing with patients an action plan for ’step up’ therapy and where appropriate, a ’step down’ approach to treatment.” This may mean a more frequent monitoring of asthma patients requiring these LABAs by specialists.
LABAs are approved to treat both people with asthma or with chronic obstructive pulmonary disease (COPD). The new recommendations only apply to the use of LABAs in the treatment of asthma. The FDA is actively seeking to reduce the use of LABA in both children and adults. They will be monitoring the sales of single LABA use and dual therapy before and after this announcement.
For the full release click here FDA Announces New Restictions on LABA.
Here are the source documents:
LABA Information -
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm199565.htm
Q&As -
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm200719.htm
Drug Safety Communication -
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm
Sami L. Bahna, MD, DrPH, FACAAI, FAAAAI
President, American College of
Allergy, Asthma & Immunology
Paul A. Greenberger, MD, FAAAAI, FACAAI
President, American Academy of
Allergy, Asthma & Immunology