Patients with asthma may recall that in 2011, an over-the-counter (OTC) asthma inhaler, Primatene Mist (epinephrine) was removed from the shelves. This was due to the propellants used in the inhaler, chlorofluorocarbons (CFCs), which are harmful to the environment and are no longer permitted. The Food and Drug Administration (FDA) has recently approved a newer version of this inhaler which instead of CFCs uses hydrofluoroalkanes (HFAs) as a propellant, similar to many prescription asthma inhalers. With this new approval, it is a fitting time to discuss why allergists, both then and now, have discouraged use of this OTC treatment for the symptoms of asthma.
Asthma is a chronic disease that involves the airways of the lung. Symptoms include cough, wheezing and shortness of breath. Well-known triggers such as exercise or allergies may cause acute symptoms and lead to inflammation in the airways. The treatment approach to asthma is highly individualized and patients strongly benefit from a tailored approach from their allergist or healthcare provider, rather than relying on OTC medication. The FDA recommends that Primatene Mist is only appropriate for people with a prior diagnosis of asthma and only those with mild symptoms of intermittent asthma (such as those with no more than two asthma attacks a week). They also recommend that patients not stop their prescribed medicine to take Primatene Mist.
It is important to realize that asthma is on a continuum from mild to severe, and many patients may move from one category to another. The Centers for Disease Control and Prevention (CDC) estimates that more than 3,500 people die from asthma every year, and these deaths can occur equally in patients with a diagnosis of ‘mild’ asthma, as in those with a diagnosis of ‘severe’ asthma, so even those with only mild, intermittent asthma need to be followed regularly. Patients who rely frequently on a medicine to open their airways (a ‘rescue inhaler’) likely need additional treatment to reduce the inflammation in the airways (a ‘controller inhaler’), and without control of the inflammation, symptoms may progress, lead to permanent lung damage, or to death. The medication in Primatene Mist, inhaled epinephrine, has side effects such as increased heart rate and blood pressure, and is not listed as a recommended treatment in the National Institute of Health’s Guidelines for the Diagnosis and Management of Asthma. For these reasons, speak to your allergist before using Primatene Mist.
Patients with a chronic cough who do not yet have a diagnosis of asthma should not take this medication. They may require a full work-up by their physician, as there are many other causes of cough that need to be taken seriously or treated differently.
Additionally, while this product contains epinephrine, it is not indicated in the treatment of severe allergies such as food or bee sting allergies, where injectable epinephrine or epinephrine autoinjectors are the mainstay of treatment.
In the FDA approval, Primatene Mist is indicated for the temporary relief of mild symptoms of intermittent asthma in patients aged 12 years or older and should not be used as a replacement for prescription asthma medications. It should be noted that the device has been redesigned, so the use of the newly approved Primatene Mist differs from the version available OTC until 2011. Unlike the previous version, the newer version is not indicated in the treatment of children younger than 12 years of age.
This article has been reviewed by Andrew Moore, MD, FAAAAI