WASHINGTON -- Primatene Mist, the over-the-counter epinephrine inhaler for quick asthma relief, can go back on the market in a reformulated version, the FDA said Thursday.
Now using a hydrofluoroalkane (HFA) propellant in place of the banned chlorofluorocarbon (CFC) used in the original Primatene product (and most other asthma inhalers), the new version is approved for "temporary relief of mild, intermittent asthma," the agency said.
Manufacturer Amphastar Pharmaceuticals noted that it may be used by patients as young as 12. In addition to the HFA propellant, the new version comes with a built-in spray indicator and a metal canister. The original Primatene Mist came in a glass container.
That product was taken off the market in 2011 because of the CFC propellant, as the U.S. completed the process of removing all CFC chemicals from consumer products. An international treaty in 1999 had banned CFCs worldwide to preserve the Earth's high-altitude ozone layer; as part of its implementation, the FDA ordered makers of asthma inhalers with CFC propellants in 2008 to take them off the market. All the major types were then reformulated with more environmentally friendly propellants, mainly HFA, although the switch generally led to higher prices and complaints from patients.
Amphastar had sought to reintroduce its reformulated Primatene in 2014. But an FDA advisory committee voted against recommending approval, citing safety problems with the new device, as well as concerns about allowing patients with a serious illness to medicate themselves without having to consult a healthcare professional. In 2016, the FDA told Amphastar to conduct a "Human Factor validation study to assess consumers' ability to use the product without the guidance of a doctor or pharmacist," and to make changes to the product's labeling, before it would approve the product.
In announcing the final approval on Thursday, top FDA officials said they were now satisfied that most patients would use the new Primatene Mist safely, while also acknowledging that risks still remain.
"In the OTC space, it's always important that the consumers understand how to safely and effectively use a new product. The scientific information we reviewed to approve the new version of OTC Primatene Mist shows there is a narrow population of those diagnosed with asthma that may benefit from having access to this type of OTC asthma inhaler," said FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, director of the agency's drugs division, in a statement.
"But the product has certain cautions," they continued. "Making sure that patients can understand and apply the instructions for use was a critical consideration for the FDA. The new product is only appropriate for those with a diagnosis of mild, intermittent asthma. Patients with more severe asthma should not rely on it. Instead, they should be working with their health care provider to ensure an appropriate treatment plan for their condition. You'll see that this risk is addressed in the instructions on how to use the product safely and a warning to seek medical care if the patient is using it regularly as overuse of the product is a risk."
Gottlieb and Woodcock urged providers who recommend Primatene Mist to let patients know the new version works differently from the original, and therefore they should pay close attention to the label information on dosing.