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U.S. Department of Health and Human Services

Drugs

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Safety Concerns with Asthmanefrin and the EZ Breathe Atomizer

[9-30-2013] FDA warns patients, caregivers, and health care professionals of the potential harm of using Asthmanefrin (racepinephrine) and the EZ Breathe Atomizer. Asthmanefrin is an over-the-counter (OTC) product for the temporary relief of mild symptoms due to bronchial asthma.

FDA has received multiple adverse event reports since Asthmanefrin went on the OTC market in September 2012, including complaints of chest pain, nausea/vomiting, increased blood pressure, increased heart rate, and patients coughing up pink/red-colored sputum (hemoptysis).
 
In addition, a nationwide recall was recently initiated for certain lots of Asthmanefrin Starter Kits that contained faulty EZ Breathe Atomizers that posed a choking hazard due to the possibility of a washer being dislodged during use.
 
Asthmanefrin’s labeling directs patients to use the product along with the EZ Breathe Atomizer, which turns the inhalation solution into a continuous vapor. Asthmanefrin solution is sold in an Asthmanefrin Starter Kit, which contains 10 filled vials and is packaged with the EZ Breathe Atomizer. Asthmanefrin is also sold in refills of 30 vials.
 
Asthmanefrin has not been evaluated by FDA for safety and efficacy under the new drug application process. 
 
Furthermore, FDA will give further consideration to the general question of whether inhaled products intended for the treatment of asthma should be evaluated only pursuant to the new drug application (NDA) process. FDA will announce details about a public meeting to discuss the inhaled bronchodilator drug products (epinephrine and racepinephrine) under the OTC monograph system.
 
Health care professionals and patients should report adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting program:
 
  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178