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FDA Statement

FDA statement on approval of OTC Primatene Mist to treat mild asthma

For Immediate Release:
Statement From:
Scott Gottlieb, M.D.


One of our ongoing priorities is making sure consumers have access to the medicines that help keep them healthy. Part of this access includes the availability of safe and effective nonprescription, over-the-counter (OTC) medications that can help empower consumers to address medical conditions.

In order for a product to be approved by the FDA for OTC use, we make sure the product receives a robust scientific review to ensure it can be used safely by patients. While OTC medicines play an important role in public health, with certain OTC medicines, there comes a more complex need to make sure that consumers understand how to best use the product to manage their health as OTC medicines are not one-size-fits all. 

We’ve made expanding access to OTC products a high priority and have worked on new legislative and policy proposals to promote access to safe and effective OTC drugs. Yesterday the FDA approved a new version of Primatene Mist, the only OTC metered-dose inhaler. This product has been the subject of past and current interest by patients and providers, and we want to take this opportunity to address some of the considerations that went into this approval, and the risks and benefits that inform the product’s proper use.

Primatene Mist is approved by the FDA to provide temporary relief for symptoms of mild, intermittent asthma. This OTC drug is approved only for those who have been diagnosed with asthma by a health care provider. Asthma is a serious health condition that requires careful assessment and ongoing follow-up with a health care professional. It’s important for us to note that Primatene Mist is not a replacement for prescription asthma treatments. Patients with asthma should be under the care of a health care professional.

Some may remember the former OTC Primatene Mist that was taken off the market in 2011 because it contained chlorofluorocarbon (CFC) propellants, which are known to deplete the ozone layer. This new version contains hydrofluoroalkane 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. When Primatene Mist came off the market during the CFC phase out, many people objected to the removal of the product. Among those were patients with mild asthma who had been using the product successfully. There was also concern for underserved populations who had no other access to asthma treatment. At the same time, we also heard from practitioners concerned with the product remaining on the market. They believed asthma patients could be harmed by self-medicating with an OTC product and that appropriate asthma care included regular care and supervised care by a health care provider, including the use of inhaled corticosteroids or other controller medications to reduce inflammation and the incidence of exacerbations. There were a complicated set of issues informing these differing views.

We’ve taken measure of all of these considerations in discussing the benefits and risks of using an OTC product for the treatment of asthma and evaluating whether use of an OTC product could potentially forestall treatment for people who needed long-term care for chronic asthma from a health care provider. We have heard from experts and gathered new information to inform our current view on these questions.

As the OTC product is being reintroduced, we’ve taken these steps to make sure those concerns were taken into account. For a number of years now, asthma inhalers have only been available by prescription from a health care provider. In the OTC space, it’s always important that the consumers understand how to safety and effectively use a new product. The scientific information we reviewed to approve the new version of OTC Primatene Mist shows there is a narrow population of those diagnosed with asthma that may benefit from having access to this type of OTC asthma inhaler. But the product has certain cautions.

Making sure that patients can understand and apply the instructions for use was a critical consideration for the FDA. The new product is only appropriate for those with a diagnosis of mild, intermittent asthma. Patients with more severe asthma should not rely on it. Instead, they should be working with their health care provider to ensure an appropriate treatment plan for their condition. You’ll see that this risk is addressed in the instructions on how to use the product safely and a warning to seek medical care if the patient is using it regularly as overuse of the product is a risk.

For the right patient, our analysis of the data, including new information that was developed since this product was previously on the market, shows that there are no serious safety concerns when Primatene Mist is used as directed. The product is appropriate for mild symptoms of intermittent asthma, however, even patients with mild asthma can have severe exacerbations—so it’s still important to consult a health care provider about appropriate care and have their condition reassessed. And, of course, all patients who experience severe exacerbations should go to the emergency room right away. 
We recognize that some consumers will be interested in the new OTC product. Asthma symptoms and recommended treatment regimens can vary from person to person. In addition, symptoms can change over time, requiring changes in treatment. To that end, it’s important that consumers discuss asthma diagnoses and treatments with their health care providers before using any new asthma product, including an OTC product, and they should not stop the treatment currently being used without talking to them first. This is especially important because some prescription asthma medications are used to control the inflammation that causes asthma symptoms to develop and these medications must be used on a regular basis to be effective.

If a health care provider recommends use of Primatene Mist, it’s also important to note that the new product looks different than the old version. The new product has updated instructions for use that consumers need to follow for the inhaler to work properly. We have learned new information about the appropriate treatment for asthma in the intervening years since this product was withdrawn from the market, the risks and benefits of different medications, and the potential role that Primatene Mist can play.

All of this information informed our assessment of the risks and benefits of this product and our decision to approve the reformulated version for OTC use. Our aim is to empower consumers in their health care decisions and provide access to safe and effective treatment options that can help promote proper care and improve patient outcomes. In doing so we cannot stress enough the importance of seeing a health care provider for any chronic condition to receive a proper diagnosis and be put on a treatment plan that works for each individual patient.



Sandy Walsh

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