Several Asthma, Allergy Groups Express "Deep Concern" Over Primatene MIST Approval

Asthma community stakeholders say approval "endangers people with asthma"
Asthma community stakeholders say approval "endangers people with asthma"

In a joint statement, the Allergy & Asthma Network, the American Association for Respiratory Care, the American College of Allergy, Asthma & Immunology (ACAAI), the American College of Chest Physicians (CHEST), the American Lung Association, the American Thoracic Society, and the Association of Asthma Educators expressed "deep concern" over the recent Food and Drug Administration (FDA) approval of Primatene MIST (epinephrine inhalation aerosol bronchodilator suspensionAmphastar), stating that the Agency's decision endangers asthma patients by suggesting the condition can be treated with over-the-counter (OTC) products. 

Primatene MIST was approved earlier this month for OTC use for the temporary relief of mild symptoms of intermittent asthma (eg, wheezing, tightness of chest, shortness of breath) in patients aged ≥12 years; it should not be considered a replacement for prescription asthma medications. 

In their statement, the groups also noted that the active ingredient, racemic epinephrine, is not considered a recommended treatment under the National Institute of Health's Guidelines for the Diagnosis and Management of Asthma

"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," said 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." 

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Concerns over the approval of Primatene MIST were recently addressed in a statement from FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, director of the Center for Drug Evaluation and Research. In an FDA press release, they stated that "For the right patient, our analysis of the data, including new information that was developed since this product was previously on the market, shows that there are no serious safety concerns when Primatene MIST is used as directed. The product is appropriate for mild symptoms of intermittent asthma, however, even patients with mild asthma can have severe exacerbations—so it's still important to consult a healthcare provider about appropriate care and have their condition reassessed." 

Primatene MIST is set to launch in pharmacies in early 2019.

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