News & Views

Using Primatene® MIST as Directed

A conversation with the director of the CDER's Division of Nonprescription Drug Products

In this conversation, Theresa Michele, MD, the director of the CDER's Division of Nonprescription Drug Products, discusses Primatene® MIST and how it differs from the older, discontinued version. She also mentions the importance of talking to your doctor about asthma treatment.

Primatene® MIST:

  • Was approved by the Food and Drug Administration on November 7, 2018 for the temporary relief of mild symptoms of intermittent asthma.
  • Is the only FDA-approved asthma relief inhaler available without a prescription
  • Is not intended for people with moderate or severe asthma
  • Why was the original Primatene® MIST inhaler taken off the market in 2011?

The previous version of Primatene® MIST contained chlorofluorocarbon (CFC) to move the active ingredient (epinephrine) out of the container. CFCs are known to deplete the ozone layer. As part of the 1989 Montreal Protocol of Substances that Deplete the Ozone Layer and the Clean Air Act of 1990, epinephrine inhalers that contained CFCs were phased out of the market in 2011.

The new over-the-counter (OTC) product contains hydrofluoroalkane (HFA) propellants, which are permitted under current international and U.S. law. Prescription-only inhalers that use different medications, such as albuterol and levalbuterol, also use HFAs as propellants.

  • How is the new version different from the old? How does it work?

The new version uses the same active ingredient (epinephrine) as the old version. But the inhaler has been redesigned. The new inhaler functions differently than the original, and consumers need to follow the instructions for use found in the product packaging for the device inhaler to work properly.

For example, the inhaler must be activated a certain way upon first use. Consumers need to:

  • Clean the inhaler after each day of use to prevent buildup of the medicine in the inhaler
  • Shake the inhaler and spray once into the air before each use

It may seem strange to shake and spray the inhaler into the air each time before using it. But these two steps are critical to ensure that the medicine is properly mixed before each dose.

The new version is approved for use in people ages 12 years and older. Do not use this medicine in children younger than 12 years. It is not known if the product works or is safe in children younger than 12 years. By contrast, the old version was approved for ages 4 and up.

  • When should I use Primatene® MIST?

You can use Primatene® MIST for temporary relief of mild symptoms of intermittent asthma. These symptoms include include:

  • Wheezing
  • Tightness of the chest
  • Shortness of breath

See a doctor right away if:

  • Your asthma is not better within 20 minutes of use
  • Gets worse
  • You need more than 8 inhalations in a 24-hour period
  • You have more than 2 asthma attacks in a week

These may be signs that your asthma is getting worse and you need a different treatment.

  • What should I expect when using Primatene® MIST?

Remember not to use Primatene® MIST unless a doctor said you have asthma. There are other conditions that can cause wheezing, tightness of the chest, and shortness of breath.

It is also important not to use Primatene® MIST if you are taking a prescription monoamine oxidase inhibitor (MAOI), which are certain drugs taken for depression, psychiatric or emotional conditions, or Parkinson’s disease.

  • If a person used Primatene® MIST before it was discontinued, but is now using a prescription asthma inhaler, is it OK to go back to using Primatene MIST in place of the prescription drug?

You should not stop taking the prescription drug you are currently using without first talking with your doctor. Importantly, some prescription medications are used to control the inflammation that causes asthma symptoms and must be used on a regular basis.

It is also important to note that the new product looks different than the old version and has new instructions for use that consumers need to follow for the inhaler to work properly.

  • Are there other over-the-counter asthma inhaler medications available in the United States?

Primatene® MIST is the only FDA-approved metered-dose inhaler approved for over-the-counter use for mild symptoms of intermittent asthma. Other inhaler products to treat asthma are prescription-only.

There are some asthma products that are labeled as homeopathic and sold over the counter, but these have not been evaluated by the FDA for safety and effectiveness. In 2015, the FDA warned consumers not to rely on these homeopathic products for managing asthma. If asthma is not appropriately treated and managed, patients may have wheezing, shortness of breath, and coughing. They could be at risk for life-threatening asthma attacks that may require emergency care or hospitalization.

  • Why is it important to consult a doctor about asthma treatment?

Primatene® MIST is approved only for treating "mild, intermittent asthma." It is not a replacement for prescription asthma treatments. You should first talk to your doctor before using this product. People who do not have asthma should not use it. If you do have an asthma diagnosis, be sure to discuss a treatment plan with your doctor. Asthma symptoms and recommended treatment regimens can vary from person to person. In addition, symptoms can change over time, making it necessary to change your treatment regimen. Your doctor can help you manage your asthma over the long term.

  • Are you concerned that consumers may misuse Primatene® MIST and avoid seeing their doctors for asthma—or use the inhaler for reasons other than asthma?

Primatene® MIST should only be used for mild symptoms of intermittent asthma, not for more moderate or severe asthma or daily symptoms. Primatene® MIST should not be used without a proper diagnosis of asthma by your doctor.

The Primatene® MIST label states, "Because asthma may be life threatening, see a doctor if you are not better in 20 minutes, get worse, need more than 8 inhalations in 24 hours, or have more than 2 asthma attacks in a week. These may be signs that your asthma is getting worse."

  • Could Primatene® MIST cause adverse asthma outcomes or heart issues because it is readily available over the counter?

While high doses of epinephrine, the active ingredient in Primatene® MIST, may lead to increased heart rate or blood pressure, these concerns have not been seen at recommended doses. This is why it's important to follow dosing instructions and ask a doctor before use if you have ever been hospitalized for asthma, are taking prescription asthma drugs, or have heart disease or high blood pressure. Based on the safety and efficacy data we have on Primatene® MIST, we believe this product is safe for over-the-counter use when used as directed for mild symptoms of intermittent asthma.

Consumer notes

Asthma is a serious disease of the lungs. Primatene® MIST is intended only for people who have been diagnosed by their doctor with intermittent asthma. Primatene® MIST is not a substitute for prescription asthma treatments. Primatene® MIST is not for people with moderate or severe asthma.

To learn how to use Primatene® MIST correctly, watch these videos.