Tonya Winders, President and CEO of Allergy & Asthma Network Mothers of Asthmatics (AANMA) will speak in opposition to the approval of Primatene HFA at the upcoming joint meeting of the FDA’s Nonprescription Drugs Advisory Committee and Pulmonary Allergy Drugs Committee, the organization has announced.
The AANMA contends that Armstrong’s OTC Primatene HFA “endangers patients by encouraging substandard treatment.” According to Winders, “Over-the-counter inhaled epinephrine treatment for asthma is dangerous and could delay care because it sends the false message that asthma is easy to self-diagnose and self-treat.”
The AANMA announcement listed the following objections:
- Inhaled epinephrine is not a recommended treatment for asthma, according to National Institutes of Health asthma guidelines.
- Primatene HFA does not have a dose counter to help users track how much medicine remains in the inhaler. AANMA has long campaigned for dose counters as essential for patient safety and FDA recommended them for all new inhalers in 2003. Studies show that patients who carry an inhaler with a dose counter are less likely to require an emergency room visit than those without one.
- The Primatene HFA canister contains 200 epinephrine doses, a size AANMA believes could encourage patients to wait too long to seek necessary medical attention or a follow-up appointment.
The organization also protested the approval of OTC status for Sanofi’s Nasacort nasal spray. That product was approved for OTC sales by the FDA in October 2013.
Read the AANMA press release.
