Do OTC Epinephrine Inhalers Containing CFCs Provide an Essential Public Health Benefit?

The combined Nonprescription Drug and Pulmonary-Allergy Drug Advisory Committees indicated on January 24, 2006, that nonprescription epinephrine inhalers used to treat mild asthma do not merit an "essential use designation" for ozone-depleting CFCs. This designation is now required by the Clean Air Act in order to stay on the market. Although continued use of CFC containing inhalers was the main issue, the majority of the meeting was focused on whether access to OTC epinephrine inhalers is vital for patients with asthma. Asthma is an inflammatory airway disease that should primarily be treated using long-term prescription anti-inflammatory therapies. Most experts believe that epinephrine inhalers should be reserved for emergency situations in patients who have a diagnosis of asthma and do not have access to their own prescription medication. One reason for this opinion is that the duration of action with epinephrine inhalers is very short, only treating symptoms of an asthma attack for an average of 23 minutes. Thus overuse of the OTC inhalers, or relying on OTC inhalers to self-medicate without proper oversight by a healthcare practitioner, can be dangerous. Deaths from suspected overuse have been reported. Safety and efficacy was originally studied in small numbers of patients prior to the original OTC approval in 1956. Much has been learned since that time about the disease process itself along with the development of safe and effective prescription therapies. There are no current label comprehension studies, which could help decide if these products are safe for self-care. Using the advisory committee recommendations, the FDA can choose to remove the product from the market by issuing a ruling. This ruling would be followed by an open time period for public comments followed by a final ruling. Wyeth, the current manufacturer of the epinephrine inhaler, Primatene® Mist, is in the process of developing a CFC-free version, which might not be available for several years. For more information, go to: http://www.fdaadvisorycommittee.com Return to Top