Although an updated version of Primatene Mist will be back on the market soon, some doctors aren’t thrilled at the prospect of patients relying on the over-the-counter inhaler.
The U.S. Food and Drug Administration announced this month that it had cleared the way for Primatene Mist to return to stores, nearly a decade after it was pulled from the market for environmental reasons.
Soon after the recent FDA approval, professional groups, such as the American College of Allergy, Asthma and Immunology, began issuing statements of concern about the rescue inhaler.
“Asthma is not a ‘do-it-yourself’ disease that you can treat yourself with OTC medications,” ACAAI president Dr. Bradley Chipps said in a release. “Anyone who has asthma should be working with an allergist to make sure they are on the appropriate medication to control their disease.”
Also, “people should understand they shouldn’t go off their regular prescription medication to start taking Primatene Mist instead,” he said. “That could prove very dangerous.”
Others that signed on with ACAAI in a joint statement included the Allergy & Asthma Network, the American Association for Respiratory Care, the American College of Chest Physicians, the American Lung Association, the American Thoracic Society and the Association of Asthma Educators.
Dr. James Sublett, chief medical officer of Family Allergy & Asthma in Louisville, expressed similar concern, saying it would be better for patients “to be on controller medications and be assessed by a physician to see what status their asthma is” instead of “self-treating based on the way they feel.”
Primatene Mist is “just not what we recommend using for asthma in any regard,” said Sublett, a past president of ACAAI.
Asthma is a chronic lung disease that inflames and narrows the airways and leads to recurring periods of wheezing, chest tightness, shortness of breath and coughing, according to the National Heart, Lung and Blood Institute.
More than 3,500 people a year die of asthma, according to ACAAI.
The condition is common in Kentucky, and Louisville was No. 5 on the Asthma and Allergy Foundation of America’s 2018 list of the top 100 metropolitan cities that are the so-called most challenging to live in with asthma.
Primatene Mist — the only FDA-approved asthma inhaler that doesn’t require a prescription — is approved for the temporary relief of symptoms associated with mild, intermittent asthma in people who have been previously diagnosed by a health care provider. The drug, which has a wholesale price of about $25, is expected to be available in major drugstores in early 2019.
“For the right patient, our analysis of the data, including new information that was developed since this product was previously on the market, shows that there are no serious safety concerns when Primatene Mist is used as directed,” according to a Nov. 8 statement from the FDA.
However, patients with more severe asthma should not rely on it, according to the FDA. Also, “patients who experience severe exacerbations should go to the emergency room right away.”
The epinephrine product from Amphastar Pharmaceuticals was taken off the market in 2011 because it contained ozone-depleting chlorofluorocarbon propellants, according to the FDA. Primatene Mist’s new inhalation delivery system no longer includes those and has other significant new features, such as a built-in spray indicator and a metal canister instead of a glass one, according to the drug company.
Sublett said the product is short acting, and he worries about “the potential for overuse” as well as the risk of patients known as “under perceivers” not realizing that their condition is getting worse.
“Asthma is a chronic illness that needs to be evaluated and followed,” he said.
Groups that signed onto the joint statement said Primatene Mist “masks the symptoms that come from asthma” and that its active ingredient isn’t a recommended treatment under National Institutes of Health guidelines. A prescription drug called albuterol is the preferred rescue inhaler, Sublett said.
However, the FDA noted that many people objected to the removal of Primatene Mist from the market back in 2011, including mild asthmatics who’d successfully used the product. Also, there was concern for underserved populations with no other access to asthma treatment.