Officials say the reformulated inhaler only masks symptoms and doesn’t treat the ailment. Company says its product improves people’s lives.

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The original Primatene Mist inhaler was taken off the market in 2011 due to concerns over its impact on the ozone layer. Getty Images

After seven years, Primatene Mist is returning as an over-the-counter (OTC) inhaler for people with mild asthma.

It’s been reformulated and no longer contains ozone-destroying chlorofluorocarbons (CFCs).

The inhaler is expected to return to store shelves early next year.

You might think the asthma community would be jumping for joy.

But that’s not necessarily the case.

Healthline spoke with officials at asthma and allergy organizations who shared their concerns about Primatene’s safety and new formula.

“The experts in the field feel strongly this is not an appropriate treatment for asthma patients and it should not be back in the OTC market,” Tonya Winders, president and chief executive officer at the Allergy & Asthma Network, told Healthline.

So what’s the issue?

Winders says the OTC option actually endangers asthma patients.

“Racemic epinephrine, the active ingredient in Primatene Mist, is not a recommended treatment for asthma,” she said.

“Asthma is not an appropriate disease for the OTC setting,” Winders added. “It is not a ‘do-it-yourself’ disease.”

Some people in the asthma and allergy community feel the safety concerns are so severe, they released a joint statement that urges patients to steer clear of Primatene Mist.

The mist’s ingredients aren’t the only issue.

Asthma experts said that with increased accessibility to OTC options, people may be less likely to communicate symptoms with their medical team and this can have life-threatening consequences.

They noted that 22 million people in the United States live with this chronic condition that can require immediate action when it flares up.

They mentioned 10 people die from the ailment each day and those deaths are spread evenly among people with mild, moderate, and severe asthma.

“We know that the No. 1 reason 10 people die from asthma daily is due to lack of control and overuse of quick-relief medication,” Winders said. “This newly approved product will be used to mask the symptoms of asthma without addressing the underlying cause. Furthermore, it will likely delay access to appropriate care and could undermine the physician-patient relationship as the doctor will have no knowledge if patients are using Primatene Mist OTC.”

Kenneth Mendez, president and chief executive officer at the Asthma and Allergy Foundation of America, shared similar sentiments in an official statement:

“AAFA supports access to affordable treatment options for our community. However, it is unknown how the FDA’s approval of Primatene Mist may impact asthma outcomes. It is not currently a guidelines-based treatment.”

“As with any medication and chronic condition,” Mendez added, “it’s important for people to consult with their doctor to make sure the medication is appropriate for them.”

Primatene Mist was taken off shelves in 2011 because of environmental regulations set forth in the 1987 Montreal Protocol.

Before that, the product had been on the market for 50 years.

It remains the only OTC meter-dosed inhaler. The rest are available only by prescription.

The new Primatene Mist formula was approved by the FDA last week.

In a press statement, FDA officials said the Primatene Mist approval is part of the agency’s efforts to increase the number of OTC products.

“One of our ongoing priorities is making sure consumers have access to the medicines that help keep them healthy,” the statement reads. “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.”

They note there were objections from some consumers when Primatene Mist was removed from store shelves in 2011.

“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,” the FDA statement reads. “There was also concern for underserved populations who had no other access to asthma treatment.”

FDA officials said last week’s Primatene Mist approval came after an extensive review of the benefits and risks.

At the same time, FDA officials reiterate some of the warnings from the asthma groups and strongly urge consumers to be knowledgeable of the product’s limitations.

“Primatene Mist is not a replacement for prescription asthma drugs,” FDA officials told Healthline. “As with the use of any medication, patients should talk to their doctor about treatment options.”

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Image via Amphastar Pharmaceuticals Inc.

Officials at Amphastar, the manufacturer of Primatene Mist, said their product will bring welcome relief to many of the 22 million people in the United States who have asthma.

“Amphastar’s mission is to develop and bring to market innovative pharmaceutical products and delivery systems that will meaningfully improve peoples’ lives and we believe Primatene Mist will do just that,” said Dr. Jack Zhang, Amphastar’s chief executive officer, in a statement.

On Amphastar’s Primatene Mist website, the company describes the product, with capital letters for emphasis, as providing “TEMPORARY relief of MILD symptoms of INTERMITTENT asthma.”

It adds that because “asthma is life-threatening,” people who are experiencing serious or persistent symptoms should see their doctor.

Officials with Amphastar referred Healthline to the FDA statement for further comment.

Key stakeholders in the asthma awareness and advocacy community don’t recommend the use of Primatene Mist for people with asthma.

They say the new formula has a number of safety concerns.

One is that a key ingredient in the inhaler known as racemic epinephrine is not an approved treatment for asthma.

Another is that because Primatene Mist masks the symptoms of asthma, people with the ailment will not provide complete information about their condition to their doctors.

Experts say people with asthma should consult with their medical team before switching or supplementing medications.