Asthmanefrin and EZ Breathe Atomizer Problems Result in FDA Warning

Federal regulators have issued a warning about reports of problems involving a new over-the-counter bronchial asthma drug, known as Asthmanefrin, after several people have indicated that they experienced severe side effects.  

The FDA issued a safety alert on September 30, warning patients about the potential side effects of Asthmanefrin, an inhaled asthma medication used for temporary relief of mild bronchial asthma symptoms.

Several complaints concerning the Asthmanefrin were filed with the FDA since the drug entered the U.S. market in September 2012. According to the federal regulatory agency, patients have reported experiencing chest pain, nausea, increased blood pressure and heart rate, as well as coughing up pink colored sputum.

Asthmanefrin, manufactured by Nephron Pharmaceuticals Corp., is an over-the-counter asthma medication which contains racepinephrine and has not been evaluated by the FDA under the new drug application (NDA) guidelines.

It is sold in starter kits with the EZ Breathe Atomizer, which was recalled last April because of problems associated with a manufacturing defect. The atomizer converts the asthma solution into a vapor for delivery. The kits contained 10 filled vials and an atomizer, but are also sold in refills of 30 vials.

The EZ Breathe Atomizer recall was issued because a washer in the atomizer packaging could become dislodged during use, putting patients at risk of accidental choking or swallowing.

Although no injuries were reported as a result of the recall, which involved nearly 250,000 atomizers, it was categorized as a Class I Medical Device Recall, which is the most serious type of recall and is only issued when the potential for a product to cause serious health problems, or even death, may occur. The atomizer was sold to Nephron by Health & Life Co. Ltd., a health manufacturing company based in Taiwan.

The FDA warned patients of the potential health risks of the product and will consider a potential NDA evaluation of inhaled asthma products by holding a meeting in early 2014.

“In light of FDA’s concerns about the use of OTC racepinephrine and similar drugs for the treatment of asthma, FDA has decided to 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 process,” the FDA said in a press release.