Asthma relief soon to revert to Rx-only indication

Primatene Mist to be discontinued at year-end

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced that the only over-the-counter asthma inhaler sold in the United States no longer will be available as of Dec. 31 as part of an international agreement to stop the use of substances that damage the environment.

Armstrong Pharmaceuticals’ Primatene Mist (epinephrine) is approved by the FDA for the temporary relief of occasional symptoms of mild asthma. As part of the announcement, the FDA urged those who use Primatene Mist to see a healthcare professional soon to switch to another asthma medicine.

Primatene Mist inhalers are being discontinued because they use chlorofluorocarbons, or CFCs, as a propellant to move the medicine out of the inhaler so patients can breathe the medicine into their lungs.

“There are many other safe and effective medications to treat the symptoms of asthma,” stated Badrul Chowdhury, director of the FDA’s Division of Pulmonary, Allergy and Rheumatology Products. But you need to find out if you really have asthma — not just pick another over-the-counter medicine, Chowdhury added. “If you have breathing problems but have not been diagnosed by a healthcare professional, it’s important to see one. Not all breathing problems are asthma, so you need to get an accurate diagnosis and the proper medicine.”

Many manufacturers have changed their inhalers to replace CFCs with an environmentally friendly propellant called hydrofluoroalkane, or HFA. There currently is no HFA version of the Primatene Mist inhaler.

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