An over-the-counter (OTC) asthma inhaler up for approval by the U.S. Food & Drug Administration (FDA) endangers patients by encouraging substandard treatment, according to Allergy & Asthma Network Mothers of Asthmatics (AANMA), a leading nonprofit patient education and advocacy organization.
On Feb. 25, FDA’s Nonprescription Drugs Advisory Committee and Pulmonary Allergy Drugs Committee will host a joint meeting to consider a new drug application for Primatene HFA, an OTC epinephrine inhaler manufactured by Armstrong Pharmaceuticals.
“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,” says AANMA President and CEO Tonya Winders.
Asthma is a chronic condition that kills 10 people a day in the United States – but many patients don’t realize the danger. “It is not an over-the-counter disease,” Winders says. “Patients should be evaluated, treated and prescribed asthma medication under the direction of a qualified health care professional.”
Winders is scheduled to testify at the Feb. 25 hearing. Additional AANMA concerns:
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.