The recent FDA decision to put the metered-dose epinephrine inhaler Primatene Mist™ back on drugstore shelves was met with alarm by asthma specialists and respiratory health groups who warned that the move will place asthma patients at risk.
Pulled from the market in 2011 along with other asthma inhalers due to environmental concerns about their ozone-depleting chlorofluorocarbon (CFC) propellants, a CFC-free version of the drug was approved last November for over-the-counter (OTC) sale -- despite objections from the (ATS), and other health groups that the move could led to suboptimal treatment and poorer asthma control if patients rely solely on the OTC medication to treat symptoms.
And now three asthma specialists, , decry a lack of transparency leading up to the FDA's decision.
"The recent FDA approval of Primatene Mist without public input and despite longstanding concerns with epinephrine metered-dose inhalers (MDI) has set a dangerous precedent," wrote S. Christy Sadreameli, MD, and Emily Brigham, MD, of Johns Hopkins School of Medicine, Baltimore, and Ajanta Patel, MD, of The University of Chicago.
The commentary noted that the FDA decision to allow Amphastar Pharmaceuticals to market its non-CFC version of the epinephrine inhaler for the treatment of symptoms related to "mild, intermittent" asthma was made without an official public comment period, advisory panel review, or input from medical societies. (Not entirely true: an to discuss Amphastar's CFC-free reformulation, and recommended against approval.)
In , then-FDA commissioner Scott Gottlieb, MD, noted that the agency "heard from experts and gathered new information to inform our current view on these questions."
But pediatric asthma specialist Michael Blaiss, MD, of the Medical College of Georgia, said he could find no evidence to back up this claim when he reached out to leading allergy and asthma professional and lay organizations, including CHEST, ATS, the Allergy and Asthma Network, and the Asthma and Allergy Foundation of America.
Blaiss is executive medical director and past president of the American College of Allergy, Asthma and Immunology. "None of us were consulted before this ruling was made," he told 51˶.
He cited two objections to the reintroduction of Pristine Mist. First, the Global Initiative for Asthma (GINA) and other guidelines recommend inhaled albuterol for the treatment of acute asthma symptoms because albuterol controls symptoms longer and has fewer side effects than epinephrine MDI. Newly updated GINA guidelines also support the used of as-needed inhaled corticosteroids for all patients with asthma -- even those with mild asthma -- to reduce inflammation and reduce exacerbation risk.
In addition, patients who rely on the OTC epinephrine drug for symptom relief may not get the medical care they need or receive inhaled corticosteroids (ICS) to keep their asthma under control.
"Epinephrine is great for anaphylaxis, but it is not an appropriate treatment for acute asthma flare-ups and it does not treat the underlying cause of asthma," Blaiss said.
In their commentary, Sadreameli, Brigham, and Patel suggested placing Primatene Mist behind pharmacy counters as a strategy to mitigate patient risk.
"Behind-the-counter sales are not under FDA oversight, so pharmacy retailers would have to do this voluntarily," they wrote.
Last January, 11 health groups including ATS, CHEST, and AAAAI to major pharmacy chains requesting that they make the voluntary move.
In an interview with 51˶, Sadreameli said placing the OTC drug behind the counter would then necessitate a discussion with a pharmacist, "who would know that other medications are considered more effective for asthma" and perhaps recommend them.
"We would hope they would have that conversation," she said.
"Another possible solution, though controversial, is OTC albuterol," Sadreameli, Brigham and Patel wrote. "However, any OTC asthma therapy increases convenience at the expense of professional evaluation and safety and provides an opportunity to bypass ICS use, now recommended for use with all levels of asthma severity."
Primary Source
Annals of ATS
Sadreameli SC, et al. "The surprising reintroduction of Primatene Mist in the United States" Annals ATS 2019; DOI: 10.1513/AnnalsATS.201902-164HP.