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Inhalation February 2019 23 the patented formulation of Pri- matene Mist is made with the same active ingredient, epineph- rine, which was used in the origi- nal Primatene Mist before it was removed from the market in 2011 to meet requirements of the Mon- treal Protocol. The product has other new features, including a built-in spray indicator and a metal canister that replaces the glass container used in the origi- nal Primatene Mist product. Amphastar expects Primatene Mist to be available in major drug stores across the US in early 2019. References Content for this article was based on and excerpted from: • Amphastar Pharmaceuticals, Inc. announces reintroduction of Primatene ® Mist, November 7, 2018. http://ir.amphastar. c o m /n e w s - r e l e a s e s /n e w s - r e le a s e - d e t a i l s /a mph a s t a r- pharmaceuticals-inc-announ ces-reintroduction. • Statement from FDA Commis- sioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evalua- tion and Research, on approval of OTC Primatene Mist to treat mild asthma, United States Food and Drug Administration, November 8, 2018. https:// w w w.fd a .gov/ Ne w sEvent s/ Ne w sroom / Pre s s A n nou nc e ments/ucm625338.htm. • FDA decision to OK Prima- tene Mist endangers asthma patients, Allergy and Asthma Network, November 9, 2018. http://www.allergyasthmanet work.org/news. Putting patients at risk The statement further says that, "Anyone with asthma should not consider Primatene Mist as a replacement for prescription asthma medications, including quick-relief albuterol inhalers and daily inhaled corticosteroids that prevent symptoms. If you have asthma and forgo or delay taking your prescribed asthma medica- tion to use Primatene Mist, you are putting yourself at risk for a more serious flare and potentially causing long-term lung damage or even death." The statement adds, "Whether symptoms are mild, moderate or severe, people with asthma are encouraged to see their primary care doctor or a board-cer- tified allergist or pulmonologist who can properly diagnose the disease and work with a healthcare team to outline an Asthma Action Plan that spells out how to treat asthma daily and what to do when symptoms worsen." Eroding patient/clinician relationships Representatives from several groups were quoted in the state- ment, including American Lung Association National President and CEO, Harold P. Wimmer, who identified an additional medical risk with the use of Pri- matene Mist saying, "The right asthma management plan can allow for a full and active life, and it requires strong communi- cation between the patient and treating healthcare provider. The availability of and the reliance on over-the-counter medication like Primatene Mist in lieu of effec- tive prescribed asthma medica- tions erodes that communication and relationship, and it may also put patients at risk for excessive cardiac stimulation." Available in early 2019 In a news release, Amphastar Pharmaceuticals explained that out talking to them first. This is especially important because some prescription asthma medi- cations are used to control the inf lammation that causes asthma symptoms to develop and these medications must be used on a regular basis to be effective." The statement closed saying, "… we cannot stress enough the importance of seeing a health care provider for any chronic condition to receive a proper diagnosis and be put on a treat- ment plan that works for each individual patient." Serious concerns from patient advocacy groups However, a joint statement against the approval was issued by multi- ple asthma patient advocacy groups and community stake- holders. The group includes the Allergy & Asthma Network, American Association for Respi- ratory Care, American College of Allergy, Asthma & Immunology (ACAAI), American College of Chest Physicians (CHEST), American Lung Association, American Thoracic Society and Association of Asthma Educators. Their statement, posted on the Allergy & Asthma Network's web- site, says the groups "believe the FDA's decision endangers people with asthma by suggesting asthma is a 'do-it-yourself ' disease treatable with OTC medications." The group statement also says that, "Primatene Mist does not treat asthma—instead it masks the symptoms that come from asthma. Furthermore, Primatene Mist's active ingredient is racemic epi- nephrine, which is not a recom- mended asthma treatment under the National Institutes of Health's 'Guidelines for the Diagnosis and Management of Asthma.'" Back Page continued from page 24 subscribe today inhalationmag.com