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FDA Re-approves Only OTC Inhaler for Mild Symptoms of Asthma



The original version of Primatene Mist was taken off the market as it contained chlorofluorocarbons (CFCs), a greenhouse gas that damages the environment. But after seven years, and an environmentally friendly makeover, the FDA announced that the inhaler will be available in pharmacies again.


What is Primatene Mist for?

Primatene Mist is the only over-the-counter (OTC) inhaler approved for the temporary relief of mild symptoms of intermittent asthma—like wheezing, tightness of the chest and shortness of breath—in patients 12 years of age and older. It should only be used when mild symptoms of intermittent asthma appear and is not for daily use.

Primatene Mist should not be used without a proper asthma diagnosis from your doctor. If you don’t feel better within 20 minutes of use, feel worse, need more than eight inhalations in a 24-hour period, or have more than two asthma attacks in a week, see a doctor right away. These may be signs that your asthma is getting worse and you need a different treatment.



What’s different about the new Primatene Mist?

Just like the older version, the new Primatene Mist contains epinephrine but has been redesigned for environmental purposes. It now contains hydrofluoroalkane (HFA) propellants, which are permitted under US law, instead of CFCs.

The new inhaler functions differently than the original, and patients must follow detailed instructions in order for the product to work properly. Before each use, the inhaler needs to be shaken and sprayed once into the air, and after each use, patients should clean the inhaler to prevent medication buildup in the device.


How much will Primatene Mist cost?

Manufacturer Amphastar Pharmaceuticals says that one Primatene Mist inhaler will cost about $25, and will be available in pharmacies in 2019.


I can’t afford my current inhaler. Should I use Primatene Mist instead?

Definitely not. Primatene Mist should only be used for mild symptoms of intermittent asthma, not severe or daily symptoms, and is not a replacement for prescription asthma treatments. Patients should speak with their primary care provider before switching inhalers.

Critics of Primatene Mist insist that patients should steer clear of the OTC inhaler as it contains epinephrine (which temporarily improves asthma symptoms but is not approved to treat asthma), but the FDA has released a statement asserting that Primatene is safe and effective if used correctly.


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