{"id":6124,"date":"2014-02-26T00:00:00","date_gmt":"2014-02-26T00:00:00","guid":{"rendered":"http:\/\/wordpress.dev\/?p=6124"},"modified":"2014-02-26T00:00:00","modified_gmt":"2014-02-26T00:00:00","slug":"us-fda-vote-no-primatene-hfa","status":"publish","type":"post","link":"https:\/\/www.achooallergy.com\/blog\/us-fda-vote-no-primatene-hfa\/","title":{"rendered":"No OTC Primatene Mist Replacement"},"content":{"rendered":"

Yesterday, a US Food and Drug Administration advisory panel voted not to recommend Primatene HFA<\/span> for over-the-counter sale. This is the latest in the attempt to bring a bronchodilator back to the over-the-counter market. There were two additional votes on the drug, and the mixed results could be reason for hope in seeing a new bronchodilator on the market in the future.<\/p>\n

_Primatene Mist - OTC BronchodilatorMany of you may recall seeing Primatene Mist<\/span> on drugstore and market shelves when you were younger. For me, it was a common occurrence as my cousin, who suffers from severe asthma, would often have this inhaler with him. After spending time in the backyard with my cousins and brothers playing football, he would pull out his inhaler, flip the top and use it if his asthma flared up.<\/p>\n

_In 2011 Primatene Mist<\/span> was phased out and removed from store shelves. These pocket-sized inhalers used chlorofluorocarbons (CFCs) to propel the epinephrine out and into the lungs of the asthma sufferer. As part of an overall move away from CFC-based propellants, the axe finally fell on Primatene Mist<\/span> in December of that year. Since then, the manufacturer, Armstrong Pharmaceuticals, has been attempting to gain OTC status for a replacement inhaler, the short-acting beta2-agonist (SABA) bronchodilator, Primatene HFA<\/span>. Currently, the only forms of this type of drug available are prescribed. If you have asthma, you might be familiar with their names, albuterol and levalbuterol. However, there is some need for an OTC alternative, particularly in case of emergencies or when people run out of their prescription at inopportune times.<\/p>\n

_In addition to ultimately voting no to OTC use, the 25 member advisory panel also voted on the efficacy and safety of the new inhaler. While there is still another ongoing clinical trial, the panel discussed the results of two other clinical trials that showed significant results. On a vote over the efficacy, 14 yes votes won out.<\/p>\n

_Lastly, the panel discussed and voted on the safety of the proposed drug. Like most drugs, Primatene HFA<\/span> did show some side effects, though even with the most severe side effect being tremors, all cases were mild. Other side effects were infrequent. A larger safety issue was likely found in the correct use of the inhaler. While the new inhaler uses an ozone-friendly propellant, the new formula is a suspension that can settle. Consequently, the inhaler must be primed four times before the first use and twice after two weeks of nonuse. It must also be washed and dried each day, and both of these present significant hurdles when it comes to ease-of-use and proper use. With regard to labeling, some members felt that patients may be led to believe that it is for daily use when only actually intended for intermittent use. All of these things resulted in 17 panel members voting no, in terms of safety.<\/p>\n

_The end result, for now, is that the new Primatene HFA<\/span> will not be in pharmacy and store shelves any time soon, but the drug does show promise. It does work, and there is a need for it. Undoubtedly, Armstrong will revisit the inhaler and attempt to address issues of misuse or mishandling.<\/p>\n

_Author: K. Gilmore<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Yesterday, a US Food and Drug Administration advisory panel voted not to recommend Primatene HFA for over-the-counter sale. This is the latest in the attempt to bring a bronchodilator back to the over-the-counter market. There were two additional votes on… <\/p>\n