Newswise — New York, NY – (Nov. 12, 2018) -- The American Thoracic Society is gravely concerned and disappointed in the FDA’s decision to approve over-the-counter epinephrine (Primatene Mist HFA) for consumer use to treat asthma. The ATS is a medical professional society dedicated to the prevention, detection, treatment and research of pulmonary disease, critical care illness and sleep-disordered breathing. Our members are experts in the diagnosis and management of asthma and have published several clinical practice guidelines for the treatment of asthma. It is with our extensive clinical expertise in the treatment of asthma and our concern for the patients that we oppose the FDA’s decision.
FDA’s decision contradicts existing and established clinical practice guidelines. Several expert panels have produced evidence-based recommendations on the treatment of patients with asthma. None of these guidelines recommend the use of inhaled epinephrine to treat asthma. The National Asthma Education and Prevention Program (NAEPP), an expert panel convened by the National Institutes of Health, has issued treatment guidelines for the management of asthma. NAEPP recommends against the use of epinephrine for treating asthma exacerbations, stating:
- Drugs of choice for acute bronchospasm: Inhaled route has faster onset, fewer adverse effects, and is more effective than systemic routes.
- The less beta2-selective agents (isoproterenol, metaproterenol, isoetharine, and epinephrine) are not recommended due to their potential for excessive cardiac stimulation, especially in high doses.” (emphasis added)[i]
By approving an over-the-counter epinephrine product to treat asthma, the FDA is endorsing a contra-indicated treatment for asthma. The FDA should know that our patients deserve better.
FDA’s decision will jeopardize patient safety. Asthma is a serious respiratory condition and even patients with mild or intermittent asthma can experience life-threatening asthma exacerbations. The FDA’s decision implies that the 25 million Americans with asthma can self-medicate their asthma condition. The agency’s decision will give patients the false impression that over-the-counter epinephrine can manage their conditions. Those who do treat their asthma with over-the-counter products will be denied access to more effective asthma medications that are proven to reduce asthma exacerbation, improve symptom control and have fewer side effects.
FDA’s decision undermines our trust in a public policy process. It is with great concern that ATS notes the agency did not conduct a public process in reaching this decision. When the FDA previously considered a product application for over-the-counter epinephrine in 2014, it held a public meeting to solicit input from the patient and provider community. At that time, a significant majority of provider and patient groups strongly opposed the re-introduction of epinephrine OTC for the treatment of asthma. In 2014, the agency did not approve the application, citing many of the concerns raised by the patient and provider community. It appears that the FDA reached today’s decision without seeking any input from these communities. We are deeply disappointed that the FDA chose to make a policy decision that potentially affects 25 million Americans with asthma, without seeking their input or that of their providers.
As physicians who care for patients with serious respiratory diseases – like asthma – we strongly urge the FDA to reconsider its decision.
[i] National Asthma Education Prevention Program– Expert Report 2 (1997) p. 64 figure 3-2.
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About the 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.