Asthma Community Not Happy with FDA Decision on Primatene Mist

A new version of Primatene Mist will soon return to the shelves of U.S. stores.

The FDA approved the over-the-counter aerosol inhaler late Wednesday. It’s indicated for temporary relief of mild, intermittent asthma symptoms in people ages 12 and up.

The original Primatene Mist disappeared seven years ago when the inhaler’s ozone-depleting propellant was banned. That version had been marketed for nearly half a century, including in memorable TV ads.

The new product developed by Amphastar Pharmaceuticals uses a safer propellant, less alcohol, and less epinephrine. The inhaler will cost about $25 and contain 160 doses. It should be available by the end of the year.

What follows is a press release from asthma community stakeholders.

A group of asthma community stakeholders released a joint statement on Friday expressing deep concern over the FDA decision to approve Primatene Mist as an over-the-counter (OTC) treatment for mild, intermittent asthma.

Allergy & Asthma Network, 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 or

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