FDA Questions Safety of Nephron's OTC Asthma Inhaler; Product Recalled

The FDA is questioning the safety of an OTC bronchodilator made by Florida-based Nephron Pharmaceuticals after finding that the product’s labeling encourages its use in an unapproved way. The inhaler device included with the drug has also been recalled due to choking concerns.

In a recent warning letter to Nephron, the agency said use of product’s bronchodilator, asthmanefrin, is potentially unsafe for use via the continuous battery-powered EZ Breathe atomizer it comes with. The drug’s active ingredient, racepinephrine HCl, is not included in the OTC bronchodilator final monograph for use via a continuous atomizer, the letter reads.

“Moreover, we are not aware of the any other evidence establishing a product such as asthmanefrin being generally recognized as safe and effective when directed for use with a continuous atomizer such as the EZ Breathe Atomizer,” the FDA said.

Nephron markets the bronchodilator kit, which contains the atomizer and 10 asthmanefrin vials, and separately-sold packages of asthmanefrin refill vials as intended for the temporary relief of mild symptoms of intermittent asthma, including wheezing, tightness of chest and shortness of breath, the agency added, citing the product’s labeling.

These claims render the bronchodilator an unapproved “new drug,” according to the agency.

CDRH also observed the company’s website and discovered the atomizer device is marketed for use “different from the intended use of a legally marketed device in the generic type of device” requiring premarket approval, the letter states.

Certain atomizers that spray liquid medication in aerosol form into the air for patients to breathe are exempt from premarket notification, the FDA said. However, they are not intended to spray liquid medication directly to a patient, “nor are they intended to be combination products labeled or packaged for use with an unapproved new drug,” the agency added. “Nevertheless, your firm has introduced the EZ Breathe Atomizer into commercial distribution with these intended uses.”

The letter states that since Nephron began selling the product in September 2012, the FDA has received numerous adverse event reports of chest pain, nausea/vomiting, increased blood pressure and possible hemoptysis associated with the use of asthmanefrin. The agency said it is also aware that the most of the kits have been recalled due to a potential choking hazard related to a washer in the atomizer device. The FDA noted the Class I recall in a safety alert Sept. 30.

The agency directed Nephron to rectify the observations noted in the warning letter and detail the various steps the company intends to take.

Nephron Chief Scientific Officer Jerry Webb said Oct. 2 the company is redesigning the atomizer to prevent the problem that led to the potential choking hazard. As for the issues noted in the warning letter, Nephron is addressing them and will provide a timely response to FDA, he said.

This isn’t the first time Nephron has been warned. The FDA in 2005 rapped the company for allegedly failing to comply with current good manufacturing practices and postmarketing adverse drug experience reporting requirements.

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