CDER Conversation: Safely Using the Newly Available OTC Asthma Inhaler Primatene Mist

Talking with Theresa Michele, M.D., who is the director of the Division of Nonprescription Drug Products, CDER.

Primatene Mist is an over-the-counter (OTC) metered-dose inhaler that is intended to provide temporary relief for symptoms of mild, intermittent asthma. Metered-dose inhalers deliver an aerosolized dose of medication to the lungs. The original OTC Primatene Mist was taken off the market in 2011, but a new version was just approved by the FDA.

In this conversation, Theresa Michele, M.D., who is the director of CDER’s Division of Nonprescription Drug Products, discusses the new product and how it is different from the old discontinued version. She also discusses the importance of talking to your doctor about asthma treatment.

In 2011, the original Primatene Mist inhaler was taken off the market. Why?

The previous version of Primatene Mist was an epinephrine metered-dose inhaler that contained chlorofluorocarbon (CFC) propellants. 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 marketing in 2011. The new 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 bronchodilator ingredient (epinephrine) as the old version. But the device has been redesigned. The new device functions differently than the original, and consumers need to follow the detailed instructions for use found in the product packaging for the device to work properly. For example, the device must be activated a certain way upon first use. Users need to clean the inhaler after each day of use to prevent buildup of the medicine in the device. The inhaler also needs to be shaken and then sprayed 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 and what should I expect when using it?

You can use Primatene Mist for temporary relief of mild symptoms of intermittent asthma, including wheezing, tightness of the chest, and shortness of breath. However, if your asthma is not better within 20 minutes of use, if it gets worse, if you need more than eight inhalations in a 24-hour period, or if you 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. Remember not to use Primatene Mist unless a doctor said you have asthma, as there are other conditions that can cause wheezing, tightness of the chest, and shortness of breath. It is also important not to use Primatene 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 the old OTC 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 the treatment 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 OTC asthma inhaler medications available in the United States?

Primatene Mist is the only metered-dose inhaler product approved for OTC use. Other inhaler products to treat asthma are prescription-only.

There are some asthma products that are labeled as homeopathic and sold OTC, 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 only approved 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, necessitating changes in 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 for reasons other than asthma? Could OTC availability of Primatene Mist cause adverse asthma outcomes or heart issues?

Primatene Mist should only be used for mild symptoms of intermittent asthma, not for more severe or daily symptoms, and 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." While high doses of epinephrine 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 available data we have on Primatene Mist’s safety and effectiveness, we believe this product is safe for OTC use when used as directed.

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