FDA Decision to OK Primatene Mist Endangers Asthma Patients
VIENNA, VIRGINIA (NOV. 9, 2018) – A group of asthma community stakeholders released a joint statement today expressing deep concern over the Food and Drug Administration’s (FDA) decision to approve Primatene Mist as an over-the-counter (OTC) treatment for mild, intermittent asthma.
Allergy & Asthma Network, American Academy of Allergy, Asthma & Immunology (AAAAI), American Association for Respiratory Care, American College of Allergy, Asthma & Immunology (ACAAI), American College of Chest Physicians (CHEST), American Lung Association, American Thoracic Society and Association of Asthma Educators believe the FDA’s decision endangers people with asthma by suggesting asthma is a “do-it-yourself” disease treatable with OTC medications.
Asthma is a complex, chronic condition affecting more than 22 million Americans and requiring active attention. Approximately 10 people a day die from the disease, according to the Centers for Disease Control and Prevention. Those deaths occur equally in mild, moderate and severe asthma patients.
“Anyone who has asthma should be working with an allergist to make sure they are on the appropriate medication to control the disease,” says allergist Bradley Chipps, MD, ACAAI President. “We want people with asthma to understand they should not go off
their regular prescription medication to start taking Primatene Mist. That could prove very dangerous.”
“Asthma is best managed when doctors and patients partner together to identify the most appropriate, long-term treatment plan,” adds Tonya Winders, President and CEO of Allergy & Asthma Network. “Patients should never try to figure it out on their own.”
Primatene Mist does not treat asthma – instead it masks the symptoms that come from asthma. Furthermore, Primatene Mist’s active ingredient is racemic epinephrine, which is not a recommended asthma treatment under the National Institutes of Health’s “Guidelines for the Diagnosis and Management of Asthma.”
Anyone with asthma should not consider Primatene Mist as a replacement for prescription asthma medications, including quick-relief albuterol inhalers and daily inhaled corticosteroids that prevent symptoms. If you have asthma and forgo or delay taking your prescribed asthma medication to use Primatene Mist, you are putting yourself at risk for a more serious flare and potentially causing long-term lung damage or even death.
Whether symptoms are mild, moderate or severe, people with asthma are encouraged to see their primary care doctor or a board-certified allergist or pulmonologist who can properly diagnose the disease and work with a healthcare team to outline an Asthma Action Plan that spells out how to treat asthma daily and what to do when symptoms worsen.
“The right asthma management plan can allow for a full and active life, and it requires strong communication between the patient and treating healthcare provider,” says American Lung Association National President and CEO Harold P. Wimmer. “The availability of and the reliance on over-the-counter medication like Primatene Mist in lieu of effective prescribed asthma medications erodes that communication and relationship, and it may also put patients at risk for excessive cardiac stimulation.”
A new Shared Decision Making Tool from ACAAI, CHEST and Allergy & Asthma Network helps those with asthma and their physicians discuss together the possible treatment options for uncontrolled asthma. The tool can be accessed at asthmarelief.acaai.org or asthma.chestnet.org/sdm-tool.
About Allergy & Asthma Network
Allergy & Asthma Network is the leading national nonprofit organization dedicated to ending needless death and suffering due to asthma, allergies and related conditions. Allergy & Asthma Network specializes in sharing patient-friendly, medically accurate patient information through its award-winning Allergy & Asthma Today magazine, E- newsletter, AllergyAsthmaNetwork.org website and numerous community outreach programs. Follow Allergy & Asthma Network on Facebook and Twitter @AllergyAsthmaHQ. Join at AllergyAsthmaNetwork.org/join.
ACAAI is a professional medical organization of more than 6,000 allergists-immunologists and allied health professionals, headquartered in Arlington Heights, Ill. The College fosters a culture of collaboration and congeniality in which its members work together and with others toward the common goals of patient care, education, advocacy and research. ACAAI allergists are board-certified physicians trained to diagnose allergies and asthma, administer immunotherapy, and provide patients with the best treatment outcomes. For more information and to find relief, visit AllergyandAsthmaRelief.org.
About American College of Chest Physicians®
CHEST is the global leader in prevention, diagnosis, and treatment of chest diseases. Its mission is to champion advanced clinical practice, education, communication, and research in chest medicine. It serves as an essential connection to clinical knowledge and resources for its 19,000+ members from around the world who provide patient care in pulmonary, critical care, and sleep medicine. For information about the American College of Chest Physicians, and its flagship journal CHEST®, visit chestnet.org.
About American Association for Respiratory Care
The American Association for Respiratory Care (AARC) is the leading national and international professional association for respiratory care. AARC encourages and promotes professional excellence, advances the science and practice of respiratory care, and serves as an advocate for patients and their families, the public, the profession and the respiratory therapist. Visit aarc.org
About American Lung Association
The American Lung Association is the leading organization working to save lives by improving lung health and preventing lung disease, through research, education and advocacy. The work of the American Lung Association is focused on four strategic imperatives: to defeat lung cancer; to improve the air we breathe; to reduce the burden of lung disease on individuals and their families; and to eliminate tobacco use and tobacco-related diseases. For more information about the American Lung Association, a holder of the Better Business Bureau Wise Giving Guide Seal, or to support the work it does, call 1-800-LUNGUSA (1-800-586-4872) or visit Lung.org.
About American Thoracic Society
Founded in 1905, the American Thoracic Society is the world’s leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society’s more than 16,000 members prevent and fight respiratory disease around the globe through research, education, patient care and advocacy. The ATS publishes three journals, the American Journal of Respiratory and Critical Care Medicine, the American Journal of Respiratory Cell and Molecular Biology and the Annals of the American Thoracic Society. Visit thoracic.org.
About Association of Asthma Educators
The Association of Asthma Educators was founded in 1998 and is a nonprofit organization dedicated to providing quality education to a multidisciplinary group of asthma educators. AAE serves as the premier professional organization representing healthcare professionals who identify themselves as asthma educators, many of whom will sit for the national asthma educator certification examination. AAE’s membership includes nurses, nurse practitioners, respiratory therapists, pharmacists, physician assistants, doctors, community health workers, case managers and social workers. asthmaeducators.org