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This undated product image provided by Amphastar shows Primatene Mist. A new version of Primatene Mist, an asthma inhaler, once popular, will soon return to US stores. On Wednesday, November 7, 2018, the Food and Drug Administration approved its over-the-counter inhaler for over-the-counter aerosols, starting at age 12. (Amphastar via AP) The Associated Press
By LINDA A. JOHNSON, AP Medical writer
TRENTON, N.J. (AP) – A new version of Primatene Mist, an asthma inhaler, once popular, will soon be returning to US stores.
The Food and Drug Administration approved the over-the-counter aerosol inhaler on Wednesday night. It serves to temporarily relieve mild and intermittent asthma symptoms in people 12 years and older.
Primatene Mist was arrested seven years ago because of the ban on the propellant depleting the ozone layer of the inhaler. This version had been on the market for half a century, including memorable TV commercials.
The new product developed by Amphastar Pharmaceuticals uses a safer booster. The inhaler will cost around $ 25 and will contain 160 doses. It should be available by the end of the year.
The "emergency inhalers" are intended to quickly relieve the symptoms of asthma such as wheezing, coughing, shortness of breath and chest tightness, which can be triggered by pollen, mold, mites, pet dander, stress or cold exercise.
The active ingredient of Primatene Mist, the hormone epinephrine, relaxes the muscles of the lungs to increase the airflow. This product is the only FDA-approved over-the-counter inhaler. Many prescription rescue inhalers, containing the drug albuterol or levalbuterol, are available.
In a statement released on Thursday, FDA officials expressed concern that some people may misuse or abuse the new inhaler. The agency said it should not be replaced by prescription treatments nor used by people with severe asthma.
Primatene Mist was removed from stores in 2011, but it still has many fans, including tens of thousands of people who liked the Facebook pages advocating its return. The TV ads of the older version boasted his quick relief with mentions of athletes such as Bob Gibson and Jackie Joyner-Kersee, or showing a relieved get relief while a stopwatch scored 15 seconds .
A subsidiary of Amphastar bought the rights to the product name and perfected it for several years.
The new version contains less alcohol and epinephrine, which can increase heart rate, especially if the inhaler is used too much. Side effects include tremors and vertigo.
Follow Linda A. Johnson on Twitter: @LindaJ_onPharma
The Health and Science Department of the Associated Press receives support from the Howard Hughes Medical Institute's Department of Scientific Education. The AP is solely responsible for all content.
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