New Version of Primatene Mist Inhaler Rejected by the FDA
Updated June 25, 2014.
Primatene Mist CFC Inhaler was an over-the-counter (OTC) inhaler used for the treatment of immediate asthma symptoms, but was removed from the market in late 2011 because the harmful effects of its propellant on the environment. Since that time, the only available OTC asthma medications were Primatene in tablet form and Asthmanefrin in nebulized solution form. All prescription asthma inhalers were required to switch to a different propellant, called hydrofluoroalkane (HFA), which doesn't have harmful effects on the environment.
Primatene Mist HFA OTC was recently submitted for FDA approval, but subcommittees on OTC Products and Allergy/Pulmonary Drugs rejected this proposal. The reasons cited for the rejection included the lack of a dose counter, frequent clogging of the inhaler, and the fact that inhaled epinephrine is not routinely recommended for the treatment of acute asthma symptoms.
While physician groups are happy with the FDA's decision to reject the approval of Primatene Mist, this decision may make it harder for people with asthma to obtain OTC medications for the treatment of their symptoms. This may lead to more visits to urgent care centers and emergency rooms, as well as hospitalizations for asthma. On the other hand, given the better availability of healthcare as a result of Obamacare, asthmatics should be able to see a healthcare provider for the purpose of asthma treatment, which for most asthmatics includes the use of an asthma controller therapy -- none of which are currently available OTC without a prescription.
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Primatene Mist CFC Inhaler was an over-the-counter (OTC) inhaler used for the treatment of immediate asthma symptoms, but was removed from the market in late 2011 because the harmful effects of its propellant on the environment. Since that time, the only available OTC asthma medications were Primatene in tablet form and Asthmanefrin in nebulized solution form. All prescription asthma inhalers were required to switch to a different propellant, called hydrofluoroalkane (HFA), which doesn't have harmful effects on the environment.
Primatene Mist HFA OTC was recently submitted for FDA approval, but subcommittees on OTC Products and Allergy/Pulmonary Drugs rejected this proposal. The reasons cited for the rejection included the lack of a dose counter, frequent clogging of the inhaler, and the fact that inhaled epinephrine is not routinely recommended for the treatment of acute asthma symptoms.
While physician groups are happy with the FDA's decision to reject the approval of Primatene Mist, this decision may make it harder for people with asthma to obtain OTC medications for the treatment of their symptoms. This may lead to more visits to urgent care centers and emergency rooms, as well as hospitalizations for asthma. On the other hand, given the better availability of healthcare as a result of Obamacare, asthmatics should be able to see a healthcare provider for the purpose of asthma treatment, which for most asthmatics includes the use of an asthma controller therapy -- none of which are currently available OTC without a prescription.
Read more:
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