Just because it’s over the counter doesn’t make it safe.
Inhaled epinephrine formulations, commonly known as Primatene Mist, are available over the counter. They are affordable and easily accessible at most pharmacies. You can even order it on Amazon WITHOUT a prescription! In the world of ever-rising drug costs and long waits to see PCPs or specialists, our patients are grabbing this inhaler to manage various respiratory conditions, including their asthma. So what’s the deal? Why do we care?
FDA Approval and the Fine Print
In 2011, OTC-inhaled epinephrine was removed from the market due to its use of chlorofluorocarbons in the propellant. The formulation was altered to use a propellant similar to prescription asthma inhalers. It was subsequently re-approved by the FDA in 2018, making it the only OTC-metered inhaler available for asthma management.
Here’s the catch: it’s only approved to provide temporary relief for symptoms of mild intermittent asthma in patients aged 12 years and older with a prior diagnosis of asthma. Think of those patients with no more than two asthma attacks a week.
Is it Safe?
Safety and efficacy remain a topic of debate. Epinephrine in the body can be dangerous and activate receptors that worsen cardiac function, which could be deadly if patients mistake their cough and dyspnea of cardiac origin for asthma. In addition, overuse of bronchodilators has been shown to increase both morbidity and mortality in asthmatic patients. The overall risk of OTC inhaled epinephrine doesn’t make sense when albuterol inhalers have proven to be safe and effective for asthma management.
The National Asthma Education and Prevention Program (NAEPP) 2020 guideline update for the diagnosis and management of asthma recommends against the use of inhaled epinephrine.
Side Effects of Inhaled Epinephrine
- Excessive cardiac stimulation
- Elevated blood pressure
Does It Actually Work?
Inhaled epinephrine has been compared to selective β-2-agonists for treating acute asthma. A systematic review and meta-analysis by Baggott et al. suggests that the efficacy of epinephrine is similar to that of selective β-2-agonists in treating acute asthma. However, the evidence was low quality.
What does this mean for us in the UC? Inhaled epinephrine may help treat acute asthma exacerbations in patients with mild asthma, especially if our patients do not have access to selective β-2-agonists. However, inhaled epinephrine formulations should NOT be our patients’ routine treatment for their asthma management.
The Takeaway: Proceed with Caution
Inhaled epinephrine formulations are affordable and can help our patients in a pinch. However, chronic use poses risks. We must caution our patients that inhaled epinephrine is not a replacement for prescribed medications.
To learn more, check out our Inhaled Epi for Asthma: Friend or Foe? segment with Tiffany Proffitt and expert Allergy and Immunology physician Dr. Kiranjit Khalsa on Urgent Care RAP.