Asthmanefrin: Patient counseling opportunity

Abstract

tus.2 OTC Primatene Mist was available without prescription from 1963 until December 31, 2011, when it was withdrawn from the market in compliance with the Montreal Protocol. Nephron Pharmaceuticals markets Asthmanefrin as “Your alternative to the discontinued Primatene Mist CFC Inhaler.” The battery-operated EZ Breathe Atomizer more closely resembles a nebulizer than a metered-dose inhaler. It consists of a control unit and a detachable medication cup with lid, mouthpiece, and cap. Correct assembly is required. Racepinephrine (a racemic mixture of epinephrine) is a nonselective adrenergic agonist. Beta-2–adrenergic receptor stimulation dilates bronchi. Stimulation of alphaand beta-1–adrenergic receptors leads to peripheral vasoconstriction and positive chronotropic and inotropic effects, increasing the risk of myocardial infarction and cerebrovascular accident.3 Patients with heart disease, high blood pressure, thyroid disease, diabetes, or prostatic hypertrophy should not use racepinephrine without consulting their physician. Patients taking a monoamine oxidase inhibitor or with a history of taking a monoamine oxidase inhibitor within the previous 14 days should not use racepinephrine. On June 3, 2013, FDA issued a class 1 recall for the EZ Breathe Atomizer because of a manufacturing defect that could allow a 0.25-inch washer to dislodge and become a choking hazard.4 Serial numbers of affected units are posted on the Nephron website (www. asthmanefrin.com). Patients with affected units should stop using the unit and contact Nephron Pharmaceuticals for directions on returning and replacing the unit. In late September 2013, FDA took two additional actions regarding Asthmanefrin. On September 24, the agency warned Nephron Pharmaceuticals that aerosolized Asthmanefrin is an unapproved new drug and that the claim as an alternative to Primatene Mist CFC Inhaler is false or misleading.5 On September 30, 2013, FDA warned patients and health professionals about safety concerns with Asthmanefrin.6 Adverse events reported to FDA in the previous year included chest pain, nausea/vomiting, increased blood pressure, increased heart rate, and hemoptysis. In 2014, the agency will begin discussing inhaled bronchodilator regulatory pathways. The FDA warnings do not include a mandatory recall, but patients should be advised that Asthmanefrin is not approved for use by FDA and that the safety and effi cacy of the OTC product are unknown. At the time this article was written, no nonprescription alternatives to Asthmanefrin were available. Although candidates for Asthmanefrin may exist, most patients considering this product should be referred to their physician for evaluation to obtain appropriate rescue medication because asthma is a condition best managed with prescription therapy.