Remember the over-the-counter asthma inhaler Primatene Mist? It was pulled from the market eight years ago for ecological reasons. Now a new, earth-friendly and FDA-approved version is back on pharmacy shelves—to the alarm of asthma specialists. If you or a loved one has asthma, before you grab OTC Primatene Mist to keep on hand for attacks, you need to read this.
The medical community had concerns about the metered-dose epinephrine inhaler Primatene Mist even before it was taken off the market in 2011 because the propellant used, chlorofluorocarbon (CFC), contributes to the depletion of Earth’s protective upper-atmosphere layer of ozone. The CFC problem has been solved, and the FDA approved an ozone-safe version of Primatene Mist in the fall of 2018.
However, while Primatene Mist is now safe for the atmosphere, it is not safe for people with asthma, according to many asthma specialists and respiratory-health groups, including the American Thoracic Society and the American Lung Association.
Epinephrine, the active ingredient in Primatene Mist, is also known as adrenaline—the hormone that triggers the flight-or-fight response. Because it speeds up heart rate, raises blood pressure and opens the airways of the lungs, epinephrine does improve breathing for a short period of time. However, it has not been shown to reduce the inflammation that causes asthma.
Before Primatene Mist was recalled, there were reports of lung inflammation progressing in patients who used the inhaler to treat asthma attacks to the point at which they went into respiratory failure. In some cases, it was too late to get help. In fact, no guidelines—US, European or international—approve epinephrine for treating asthma. Instead, all guidelines recommend two prescription inhalers, albuterol and corticosteroid, which are safer, much more effective and longer lasting.
According to the label, Primatene Mist can be used for “temporary relief of mild symptoms of intermittent asthma…wheezing, tightness in the chest and shortness of breath.” Experts say that these are not mild symptoms. They’re symptoms of an asthma attack that needs treatment.
The FDA has required warnings to be listed on the label/packaging…
• Call your doctor if you need more than eight treatments in 24 hours…or if you are not breathing better after 20 minutes.
• Do not use unless you have been diagnosed with asthma by a doctor…if you have been hospitalized for asthma…have diabetes, hypertension or heart disease…or for children under age 12.
Unfortunately, there is no guarantee that patients will read these cautions buried in the packaging or fully understand them. Patients who have diabetes, hypertension or heart disease are at risk for dangerously high blood pressure and rapid heart rate from inhaling epinephrine. And most experts agree that it’s time to call your doctor if two or three treatments have not helped, not the eight that the FDA warning allows.
Experts have urged that, at the very least, Primatene Mist should be kept behind the counter, which would make a discussion between the pharmacist and the patient more likely. Amphastar Pharmaceuticals, the manufacturer, has said that having worked with the FDA to put all needed warnings on the label and drug insert, this is not necessary.
So far, there is no indication that the FDA is reconsidering its decision. Since asthma attacks kill 10 to 11 Americans every day, it’s critical to take the disease seriously—and to be under the care of a doctor. In most cases, proper treatment can reduce the number and severity of attacks. Yes, it’s convenient to be able to grab something from a drugstore when you’ve forgotten your prescription inhaler or it’s run out. But you really do need to see your doctor for the prescription drugs and take other steps to minimize the number of attacks you have.
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