Asthmanefrin OTC Asthma Treatment

Learn about Asthmanefrine for the treatment of asthma. A.D.A.M

What is Asthma?

Asthma is a chronic inflammatory lung disease, which causes symptoms such as wheezing (a high-pitched squeaking sound occurring during breathing in and out), a sensation of chest tightness or heaviness, a sense of not getting enough air, and coughing. Immediate asthma symptoms occur as a result of bronchospasm, which is a contraction of smooth muscle around the airways in the lungs.

While asthma cannot be cured, it can be controlled with the use of various medicines. There are two general types of medicines that are used to treat asthma: Controller medicines that are taken on a daily basis to treat the underlying inflammation, and rescue medicines to treat the immediate symptoms of asthma caused by bronchospasm.

How is Asthma Treated?

Rescue medicines are those medicines that are taken as needed. This means that these medicines should be carried with the person with asthma, since an asthma attack can never be predicted. Rescue medicines help relax the muscle around the airways almost immediately, with the effects lasting for a few hours, but do not help the inflammation and swelling of the airways. Frequent use of a rescue medicine may be a sign that asthma is not controlled.

Examples of rescue medicines include albuterol (ProAir, Proventil, Ventolin) and levalbuterol (Xopenex).

These medicines are currently only available with a prescription. There is not likely to be any significant differences in how the different brands of albuterol work in terms of treating the acute symptoms of asthma. People may have their preferences in terms of which brand of albuterol works better for them, but there are no known studies showing that one brand is superior to another.

Is There an Over the Counter Inhaled Medicine for Asthma?

Primatene Mist CFC Inhaler was an over-the-counter (OTC) inhaler used for the treatment of immediate asthma symptoms, but was removed from the market in late 2011 because the harmful effects of its propellant on the environment. Since that time, the only available OTC asthma medications were Primatene in tablet form and Asthmanefrin in nebulized solution form. All prescription asthma inhalers were required to switch to a different propellant, called hydrofluoroalkane (HFA), which doesn't have harmful effects on the environment.

Primatene Mist HFA OTC was recently submitted for FDA approval, but subcommittees on OTC Products and Allergy/Pulmonary Drugs rejected this proposal. The reasons cited for the rejection included the lack of a dose counter, frequent clogging of the inhaler, and the fact that inhaled epinephrine is not routinely recommended for the treatment of acute asthma symptoms.

Asthmanefrin is an inhalation solution available OTC without a prescription and is marketed for the treatment of acute symptoms of asthma.

The manufacturer of Asthmanefrin claims that it is an “Alternative to Primatene Mist CFC Inhaler,” although Asthmanefrin is delivered via a handheld ultrasonic nebulizer (not unlike nebulized albuterol). Asthmanefrin contains the same active ingredient as Primatene Mist, which is epinephrine. Epinephrine is a potent bronchodilator, and therefore has similar effects to albuterol on the airways of the lungs. However, epinephrine also has more side effects than albuterol; Asthmanefrin has been reported to cause symptoms of chest pain, nausea and vomiting, increased heart rate and blood pressure, and possibly hemoptysis (blood in the sputum).

How Does Asthmanefrin Compare to Albuterol in Its Ability to Treat Asthma Symptoms?

Asthmanefrin contains 11.25 milligrams of racemic epinephrine (which contains both L- and D- isomers of epinephrine). Past studies have indicated that this dose of epinephrine causes effects on the lungs similar to a dose of nebulized albuterol of 5 milligrams. A recent study sought to determine the efficacy of Asthmanefrin compared with low-dose nebulized albuterol 1.25 milligram, through the protective effects of these medications on the lungs during a methacholine challenge.

Methacholine is a direct bronchoconstricting agent that essentially causes a mild asthma attack in people with underlying asthma, or the propensity for asthma. A methacholine challenge is used to diagnose asthma when a person with convincing symptoms shows no signs of asthma on spirometry. While methacholine challenges are mostly used in research settings, they are often used when a definite diagnosis of asthma either needs to be made or ruled out. This is particularly important in the U.S. military. In fact, I performed thousands of these tests while I served as a military allergist in the United States Air Force.

In a study published in 2014, performed by researchers in Florida, people with asthma were given inhaled nebulized epinephrine (similar to Asthmanefrin) or nebulized albuterol prior to a methacholine challenge, to see if their lungs would be protected from an asthma attack. When subjects were given a relatively small dose of inhaled nebulized albuterol (approximately half the dose that would be given in a “real world” setting), their lungs were protected far more than when the nebulized epinephrine was given. In fact, the amount of methacholine needed to drop a person’s lung function by 20% (the standard amount to consider a methacholine challenge as being “positive”) after the nebulized albuterol, was four times the amount of that required to cause the same drop of lung function after the nebulized epinephrine.

This study suggests that inhaled nebulized albuterol is far more effective at bronchodilation than inhaled nebulized epinephrine, probably with fewer side effects. Therefore, while it is convenient for people to be able to obtain Asthmanefrin OTC without a prescription, people with asthma would be better off to see their personal physician for a prescription for inhaled albuterol.

Find out the eight things you should be doing for your asthma right now.

Sources:

Mondal P, et al. Nonprescription Racemic Epinephrine for Asthma. J Allergy Clin Immunol. 2014;2:575-8.

FDA. US Food and Drug Administration. Inspections, Compliance, Enforcement, and Criminal Investigations. Nephron Pharmaceutical Corp. 9/24/13. Warning letter FLA-13-30. Available from: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm370008.htm. Accessed September 22. 2014.

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