Issue link: https://www.e-digitaleditions.com/i/1073928
The approval makes Primatene Mist the only asthma inhaler available in the US without a prescription. However, patient advocacy groups have expressed serious concerns. Back Page from practitioners concerned with the product remaining on the mar- ket. They believed asthma patients could be harmed by self-medicating with an OTC product and that appropriate asthma care included regular care and supervised care by a health care provider, including the use of inhaled corticosteroids or other controller medications to reduce inflammation and the inci- dence of exacerbations." Supporting their decision The FDA statement noted those viewpoints were considered during the approval process. In addition, their statement said, "The scientific information we reviewed to approve the new ver- sion of OTC Primatene Mist shows there is a narrow popula- tion of those diagnosed with asthma that may benefit from having access to this type of OTC asthma inhaler. 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 Pri- matene Mist is used as directed." A variety of cautions The FDA statement also pro- vided a variety of cautions including, "Asthma is a serious health condition that requires careful assessment and ongoing follow-up with a health care pro- fessional. [Primatene Mist] is approved only for those who have been diagnosed with asthma by a health care provider. [It] is not a replacement for prescrip- tion asthma treatments." The statement indicated the follow- ing text is included in the patient instructions. "Patients with more severe asthma should not rely on it. Instead, they should be work- ing with their health care pro- vider to ensure an appropriate treatment plan for their condi- tion," along with a warning to seek medical care if the patient is using it regularly, as overuse of the product is a risk. Further, the statement said, "Even patients with mild asthma can have severe exacerbations so it's still impor- tant to consult a health care pro- vider about appropriate care and have their condition reassessed. All patients who experience severe exacerbations should go to the emergency room right away. Asthma symptoms and recom- mended treatment regimens can vary from person to person. In addition, symptoms can change over time, requiring changes in treatment. It's important that consumers discuss asthma diag- noses and treatments with their health care providers before using any new asthma product, including an OTC product and they should not stop the treat- ment currently being used with- The United States Food and Drug Administration (FDA) has approved Amphastar Pharmaceu- ticals' over-the-counter (OTC) Primatene ® Mist (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler using a non-chlorofluorocarbon (non- CFC) propellant, for the tempo- rary relief of mild symptoms of intermittent asthma in people ages 12 and older. The approval makes Primatene Mist the only asthma inhaler available without a prescription in the US. How- ever, a variety groups that support patients with asthma have serious concerns about the approval. A statement from the FDA In support of its approval, the FDA issued a statement from FDA Commissioner Scott Gottlieb, MD, and Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research (CDER). Past views on Primatene Mist The statement explained that, "When Primatene Mist came off the market, many people objected to the removal of the product. Among those were patients with mild asthma who had been using the product successfully. There was also concern for underserved populations who had no other access to asthma treatment. At the same time, [the FDA] also heard US FDA approves over-the-counter, non-CFC-based Primatene ® Mist; Patient advocacy groups object continued on page 23 24 February 2019 Inhalation