Primatene Mist Inhaler Available Again

by Eli Hendel, M.D. Medical Reviewer

The original Primatene MIST, a go-to over-the counter inhaler for many people suffering with asthma, was taken off the market in 2011. The inhaler contained chlorofluorocarbon (CFC) propellants. CFC was considered a contributor to the destruction of the ozone layer. A thinning ozone layer increases human exposure to UV radiation which is a known risk factor for skin cancers. Primatene has now reappeared at drug counters but it’s now made with a non-CFC propellant. The Montreal Protocol treaty had mandated a phase out of products deemed harmful to the ozone layer by the year 2013.

It’s interesting to note that use of this inhaler was suspected to have contributed to or caused the death of a promising 17 year old model in 1995. The active ingredient, epinephrine, which can cause rapid heartbeat, in combination with other conditions, was conjectured to have caused her death. Another issue with epinephrine is that its action and effect is generalized and not airway specific like albuterol. Yet, it took an environmental concern that led to this OTC being removed from the market.

What's different about Primatene MIST?

Primatene MIST Is currently approved for the temporary relief of mild respiratory symptoms associated with intermittent asthma. Those symptoms can include wheezing, chest tightness and shortness of breath. The new drug application, approved by the FDA, allows the inhaler to be dispensed to individuals over age 12.

The drug offers an epinephrine inhalation aerosol bronchodilator suspension in a metered dose inhaler. Currently it’s the only over-the-counter approved asthma inhaler in the U.S. This new version of Primatene MIST uses hydrofluroalkane (HFA) propellants and it now has a built-in spray indicator. It also has a metal canister rather than the older glass container that was part of the original formulary.

Amphastar, the maker of the inhaler, had originally submitted to have the reformulated Primatene MIST approved back in 2016, however the FDA requested further modifications to the drug label and packaging. Those changes delayed the final approval until November of 2018.

Why was Primatene MIST taken off the market?

When Primatene MIST was originally pulled off the market many people objected, especially individuals with mild asthma who felt they had an affordable and accessible inhaler option. The inhaler was also very popular among economically challenged patients who really had few options for a cheaper treatment of their symptoms.

Now that it’s available, there is concern from practitioners who feel that asthma patients could experience harm by self-medicating with a product that they (the practitioners) can’t really monitor. Asthma care should require regular doctor visits and treatment that is supervised by a healthcare provider. In fact, the FDA gathered perspectives from experts in the field to help guide the package directions and warnings.

This inhaler is really only appropriate for a small group of asthma patients. Someone with mild, intermittent asthma can probably use a product like this. They should, however, seek medical care if symptoms persist or increase in frequency. Someone with a more severe type of asthma shouldn’t turn to an OTC inhaler like this. They really need to have an ongoing relationship with their healthcare provider who prescribes their medications and adjust therapy as needed.

The FDA did feel that “for the right patient” there should be no serious concerns with the reintroduction of Primatene MIST to the marketplace. Used correctly they determined, there are minimal safety concerns.

On the other hand, the American College of Allergy, Asthma and Immunology (ACAAI) released a statement, warning patients to not stop taking their current prescribed medications in favor of Primatene MIST. Anyone with asthma should consult with their doctor and together decide if this OTC has a role in their treatment plan.

Statistics suggest that 80 to 90 percent of individuals with asthma think their asthma is well-controlled when, in fact, it’s not. That incorrect perception can lead to serious asthma attacks and even death.

Risks of self-management

The American Thoracic Society (ATS) also made it clear that the FDA’s decision to re-release the medication runs counter to its position on asthma and asthma treatment. Their position is that having an OTC epinephrine inhaler gives people with the disease the false impression that they can self-manage their condition. Use of this drug may incorrectly replace the use of more effective medications that would have the potential to reduce asthma exacerbations and improve symptom control. With 25 million people currently diagnosed with asthma in the U.S., that leaves a lot of room for self-medicating.

Never assume that over-the-counter medication is innocuous. Do not assume that it’s safer than prescription medication. It may not be safer and it can certainly cause harm. Too much acetaminophen can cause irreparable damage to the liver. Giving a child aspirin when they are suffering from certain viral infections can cause Reye’s syndrome. Epinephrine on its own or used in conjunction with other medications can be dangerous.

From my perspective, I really want my patients to check with me so that we can work together to find the best treatment protocol for their type of asthma. It may include an OTC like Primatene MIST, but I would want to weigh in on whether the medication is the best option if a patient is considering using it as a rescue medication.

Eli Hendel, M.D.
Meet Our Writer
Eli Hendel, M.D.

Eli Hendel, M.D., is a board-certified internist/pulmonary specialist with board certification in Sleep Medicine. An Assistant Clinical Professor of Medicine at Keck-University of Southern California School of Medicine, and Qualified Medical Examiner for the State of California Department of Industrial Relations, his areas include asthma, COPD, sleep disorders, obstructive sleep apnea, and occupational lung diseases. Favorite hobby? Playing jazz music.