Feb. 1, 2019 -- Primatene Mist, an over-the-counter inhaler for asthma, is now back on drugstore shelves after an 8-year absence. Pulled from the market in 2011 due to its ozone-depleting propellant, the new inhaler has a more environmentally friendly propellant.
The FDA approved the new version for use in people ages 12 years and older for the temporary relief of mild symptoms of intermittent asthma, such as wheezing, tightness of the chest, and shortness of breath.
But not everyone is happy about its return or convinced it is safe to use unsupervised. Some doctors worry that patients, despite the drugmaker's warnings, will self-treat their asthma long-term, a risky practice.
The active ingredient in Primatene Mist is epinephrine, and none of the national guidelines on asthma treatment recommend the use of inhaled epinephrine.
Others agree that the inhaler should not be as freely available. In late January, 12 organizations, including doctor groups and nonprofits devoted to respiratory issues, asked major pharmacy chains carrying Primatene Mist to make it a ''behind-the-counter'' medicine. When medicines are behind the counter, customers have to ask for them, and thus have contact with pharmacy personnel who could steer them to medical help if needed.
Amphastar Pharmaceuticals, the drug's maker, says that leaving the drug just as it is, over-the-counter with no pharmacist interaction needed, is safe and that the company has worked with the FDA to ensure that safety.
In the U.S., nearly 19 million adults, or 1 in 12, and 7 million children, or 1 in 11, have asthma, the CDC says. Asthma causes nine deaths a day.
Primatene Mist: Old vs. New
The FDA approved the new version of Primatene Mist in November 2018, saying the medicine is meant ''to provide temporary relief for symptoms of mild, intermittent asthma.'' In its statement, it says that it is approved only for those who have been diagnosed with asthma by a health care provider and urges ongoing follow up with a health care
The metered dose inhaler allows 0.125 milligrams per spray of epinephrine, a bronchodilator, or drug that relaxes the bronchial muscle so that air passages can expand. It contains160 doses.
Deliveries began in December, says Jason Shandell, Amphastar's president, and the inhaler is now available nationwide in CVS and Walgreens. It's also sold online, retailing for about $30.
The older version was approved for ages 4 years and up, but the FDA allows the new inhaler only for people ages 12 years and older. The FDA is requiring the company to do a pediatric study in children ages 4-11.
Who Should Use Primatene Mist?
Instructions on the Primatene site are specific about Primatene's use. It's meant only for temporary relief of mild symptoms, the drugmaker says. Users are cautioned to see a doctor if they are not better in 20 minutes, if the asthma gets worse, if they need more than eight inhalations in 24 hours, or if they have more than two asthma attacks a week.
There's a lengthy list of other cautions. Those who have not been told by a doctor they have asthma should not use it. Anyone ever hospitalized for asthma needs to ask a doctor before using the inhaler, Amphastar says. Those with other health issues, including heart disease, high blood pressure, and diabetes, are also warned to get a doctor's go-ahead first.
What's the Issue?
National guidelines for managing asthma recommend against the use of inhaled epinephrine for quick or rescue relief, says Michael Blaiss, MD, executive medical director of the American College of Allergy, Asthma, and Immunology. Too much heart stimulation, especially in high doses, is one reason.
The issue of self-medicating is another concern. “Asthma to me is not a disease that can be treated without a health care provider's supervision,” says Blaiss, who’s also a clinical professor at the Medical College of Georgia, Augusta. “This is a rescue medicine, so it doesn't treat the underlying disease,” he says. “If someone is needing this medicine, they are having an asthma attack.”
Rescue medicines open the airways and provide short-term relief of symptoms. People who have asthma also receive long-term “controller” medications that manage airway inflammation and treat symptoms.
The rescue medicines, says Blaiss, are “like gargling for a strep throat. It might get rid of some of the pain, but it doesn't help the infection. We have rescue inhalers like albuterol [Proventil, ProAir] that are safe and last longer. There are already superior medicines [available] with a prescription.”
Blaiss sees a very limited role for over-the-counter (OTC) Primatene Mist. For instance, he says, “if someone was out of town, forgot the inhaler, could not get in touch with their doctor, and have a problem, OK.”
But in general, he says ''the concern is, if Primatene mist is out there, patients will think, 'I can just take this. I will just keep using this when I need it.' That's where we get concerned, because asthma is a chronic disease.”
James Li, MD, PhD, an allergist and immunologist, and a professor of medicine at the Mayo Clinic in Rochester, MN, agrees. “The concern is that if a patient is in the midst of a serious asthma attack, instead of going to the ER or calling their doctor or getting the proper treatment, the concern is they will go to the drugstore, grab the inhaler, and use it repeatedly until it's almost too late,” says Li, a former president of the American Academy of Allergy, Asthma & Immunology.
“It is a concern,” he says, “but it is unclear how often that actually happens.” Li says he is not aware of any study tracking that. Li has served as a consultant for GlaxoSmithKline's asthma and COPD medications.
Should Access to Primatene Be Controlled?
“I think at a minimum, it should be behind the counter,” says Blaiss. His organization was one of the 12 signing the letter asking CVS Health and Walgreens to keep Primatene Mist behind the counter “to help reduce inappropriate use of this medication and to protect patients from adverse events.”
If Primatene is placed behind the counter, Blaiss reasons, “maybe the pharmacist will send them to the ER, or tell them to call the doctor if it is not better.”
Officials at the American Thoracic Society, made up of doctors and others involved in lung disease care and research, initiated the letter. As of Jan. 31, the organization has not received a response from either CVS or Walgreens, says Dacia Morris, a spokeswoman.
A tablet form of Primatene, containing ephedrine to open airways and an expectorant, guaifenesin, has remained on the market. On the Primatene Tablets site, Pfizer Consumer HealthCare, which distributes it, says they are kept behind the counter at pharmacies. The tablets are also sold online.
More on ‘Behind the Counter’
“Behind the counter” can happen in different ways, says Sandy Walsh, an FDA spokeswoman. For instance, legislation on methamphetamine control requires some drugs, such as Sudafed, to be behind the counter. It contains pseudoephedrine, which can be used to illegally make methamphetamine, or meth.
When Plan B, the emergency contraception, was approved for over-the-counter sales in 2006, the FDA required it be sold only in pharmacies or stores staffed with a licensed pharmacist, Walsh says, and that it be behind the counter.
Amphastar's Shandell does not think misuse of the new inhaler will be a problem. “Amphastar worked closely with the FDA to ensure that the labeling is clear and that consumers can safely and effectively use Primatene Mist,” he says. “It is very important that asthma sufferers understand that Primatene Mist is only for mild symptoms of intermittent asthma.”
He adds that the original version “was available directly to and used safely by consumers" for more than 40 years. The removal from the market, he says, was not due to safety or effectiveness issues, but only to phase out its ozone-depleting propellant.