Primatene Mist OTC is making a comeback as it was recently FDA approved. Primatene Mist was taken off the market in the past because it contained CFC propellants that destroyed the ozone layer, we discussed this several years ago.
But the new version of Primatene Mist OTC contains different propellants (hydrofluoroalkane), which are permitted under US and international law.
Primatene Mist OTC is only approved for patients with mild intermittent asthma, it should not be used to replace a rescue inhaler (albuterol) or a daily preventive medication. Despite the objection of many asthma doctors, the FDA went ahead and approved it as it may be more affordable then prescription asthma medications.
The new product is being developed by Amphastar Pharmaceuticals and it will cost about $25 and contain 160 doses. The active ingredient is the hormone epinephrine which relaxes muscles in the lungs to increase airflow. Side effects include tremors and dizziness. Primatene Mist OTC is approved for patients 12 and up.
It is important for all asthma patients to speak with their doctor about any medication changes. Any patient who needs to use Primatene Mist OTC more than twice a week should see their doctor. More persistent asthma would require other medication to be prescribed. Any patient with asthma should work with their allergist and discuss their symptoms and treatment options. A do it yourself approach to treating asthma is not appropriate and patients should not go off their regular medications and replace it with Primatene Mist OTC.
Patient who have severe exacerbations should go to the emergency room and not rely on Primatene Mist OTC. The approved medication is for a very narrow spectrum of patients who have mild intermittent asthma and should not be used for more persistent asthmatics. If you do feel that you have to use Primatene Mist OTC frequently, you need to consult your doctor about better treatment options. Inhaled corticosteroids are the gold standard to treat persistent asthma, other medications that can be used are leukotriene modifiers such as Singulair. For more severe asthmatics, there are biologic medications that are approved such as, Xolair, Nucala, Fasenra, Cinqair, and Dupilumab. Speak to your asthma or allergy doctor to see which is best for you.
FDA’s announcement of Primatene Mist.