A man anxiously bites his nails as a cloud of inhalers floats around him.

Over the Counter Primatene Mist - A Solution or a Danger?

Primatene mist recently returned to pharmacy shelves as an over-the-counter (OTC) inhaler. Many asthmatics were elated by this news. But health care professionals have significant concerns.

What is Primatene Mist?

Early in the 20th century, scientists discovered that an inhaled solution of epinephrine could be used to provide temporary relief from some of the symptoms of asthma. And by the middle part of the century, metered dose inhalers had come into being. For more than 50 years, the branded form of epinephrine, called Primatene Mist, was sold over the counter.1 These historical inhalers used substances called chlorofluorocarbons (CFCs for short) to propel the mist into your airways. Millions of asthmatics grew used to this inexpensive asthma relief.

Then, in 2011, new regulations aimed at protecting the ozone layer went into effect prohibiting the use of CFCs. So Primatene Mist was taken off the market, as were many types of prescription quick-relief inhalers. New prescription inhalers were quickly rolled out that used the safer hydrofluoroalkanes (HFAs for short) as propellants. Unfortunately, no over-the-counter replacements have been available since then.2

But, in late 2018, the Food and Drug Administration (FDA) approved a new HFA version of Primatene Mist. It has become widely available this year.2

Why people with asthma are happy about the return

Needless to say, people with asthma who had loved the convenience and affordability of the old Primatene Mist were thrilled to hear that it is once again available in its new form, after a 7-year absence.

It's easy to use if you follow the enclosed instructions. A single canister costs around $30 at this writing. You don't need to expend the cost and time of a doctor's visit to obtain it. But, and this is a big but, is it safe?

Why health care professionals are worried

Many health care professionals, as well as health care groups express a number of concerns about the return of Primatene Mist to OTC shelves in local pharmacies, despite FDA assurances of safety.

Self-medicating

Health care experts emphasize that asthma cannot be safely or effectively managed by the patient, in the absence of any oversight from a health care team. They state that "the move could lead to suboptimal treatment and poorer asthma control if patients rely solely on the OTC medication to treat symptoms."3 They also remind us that current asthma guidelines recommend epinephrine as an emergency treatment only for anaphylaxis, not as an everyday asthma treatment.

Rather, albuterol is the drug of choice for managing quick relief of asthma symptoms, while inhaled steroids are recommended for prevention and control.3

Missing the signs

Health care professionals also stress that patients who self-medicate for asthma using Primatene Mist may miss the signs of slipping asthma control, which can have dire consequences. 10 people each day die from asthma, and this is not limited to only those with the severe form of the disease.4 The primary reason people die from asthma is due to lack of control and overuse of quick-relief medications.

In 1995, a young model, Krissy Taylor, died from asthma. She had apparently used Primatene Mist for shortness of breath and wheezing. But, she had not been diagnosed with asthma and her doctor did not know she was self-medicating.5 It's unclear whether the medication contributed to her death, but cases like hers have added to experts' concerns.

Accessibility

In January of this year, 11 health groups including ATS, CHEST, and AAAAI sent a memo to a number of major pharmacy chains requesting that at the very least, they place Primatene Mist behind the counter. This would give the pharmacist the chance to counsel consumers before buying the medication.6 I can tell you from personal observation that Walgreens has chosen to ignore that suggestion. I found Primatene Mist prominently displayed on the allergy medicine shelving.

The FDA response to Primatene Mist

In a press release in November 2018, the FDA stressed the importance of "the availability of safe and effective nonprescription, over-the-counter (OTC) medications that can help empower consumers to address medical conditions."7 They recognize that there are a couple of consumer groups who had benefited from the medication in the past and had pushed for its return:

  • People with mild intermittent asthma who'd been using Primatene Mist successfully to manage very occasional symptoms
  • Underserved populations who had no other access to asthma treatment

But they also state their understanding of concerns from health care professionals. The FDA reminds the public that Primatene Mist is only appropriate for those with a diagnosis of mild, intermittent asthma. Anyone with a more severe level of asthma should NOT be using an OTC inhaler. They also stressed the importance of written safety instructions, which the manufacturer has had to include in the packaging.

What to know about Primatene Mist

Clearly, there has not been a meeting of the minds on this issue of an OTC Primatene Mist inhaler. Many consumers want it and the FDA has approved it. Drugstores seem to be making it easily accessible, without any type of oversight. Meanwhile doctors, nurses and asthma/allergy governing groups are very concerned that patients will go undiagnosed with poorly supervised asthma control. Who is right?

To help you going forward, I'd like you to consider these questions before thinking about buying your own Primatene Mist inhaler:

  • Have you been diagnosed with asthma by a doctor, and if so, is it mild intermittent asthma? When you're not absolutely sure you have asthma, but you're having symptoms such as shortness of breath, wheezing, chest tightness or a frequent or chronic cough, then you should not be using Primatene Mist. You should be consulting with a health care professional to learn more about why you might be having those symptoms. People who have been diagnosed with mild, intermittent asthma should talk with a doctor first about whether this new inhaler might be right--and safe--for you to use.
  • If you have asthma, are you noticing symptoms more than twice a week, especially if they're waking you up during the night? If so, then these are symptoms that your asthma is not well controlled. An immediate consultation with your health care team is advised. It's likely that your treatment plan needs to be revised so that you can get your symptoms back under control.

What do you think?

I'll be honest. I have mild, intermittent asthma, and I've considered trying Primatene Mist again, having used it at one time before it was banned in 2011. I would use it primarily for exercise-induced symptoms, as I rarely have asthma symptoms any other time these days. But I'm a retired nurse and well aware of the dangers.

I'd love to hear what our community here thinks about the reintroduction of Primatene Mist as an OTC inhaler. Do you think it's a good idea? Have you used it, or do you plan to?

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This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The Asthma.net team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

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