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Proposed Asthma Inhaler Puts Patients at Risk, Group Says

FDA panels will meet on February 25 (February 19)

An over-the-counter (OTC) asthma inhaler up for approval by the FDA endangers patients by encouraging substandard treatment, according to Allergy & Asthma Network Mothers of Asthmatics (AANMA), a nonprofit patient education and advocacy group based in Vienna, Virginia.

On February 25, the 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 (Armstrong Pharmaceuticals), an OTC epinephrine inhaler.

“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.

“It is not an over-the-counter disease,” she adds. “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 February 25 hearing.

Additional AANMA concerns include:

  • 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. Studies have shown that patients who carry an inhaler with a dose counter are less likely to require an emergency room visit than are those without one.
  • The Primatene HFA canister contains 200 epinephrine doses, a size the AANMA believes could encourage patients to wait too long to seek necessary medical attention or a follow-up appointment.

Source: PR Newswire; February 19, 2014.

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