CFC Use In OTC Epinephrine Inhalers Topic Of Upcoming NDAC Meeting
This article was originally published in The Tan Sheet
Executive Summary
FDA's Nonprescription Drugs and Pulmonary-Allergy Drugs advisory committees will discuss the availability of OTC epinephrine metered-dose inhalers (MDIs) and their environmental impact during a joint meeting scheduled for Jan. 24.
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Epinephrine study
"Nonprescription epinephrine CFC-MDI is more effective and safer than what many health care professionals believe," a study in the December Annals of Allergy, Asthma & Immunology concludes. Wyeth's Primatene Mist OTC metered-dose inhaler was "nearly" as effective as GlaxoSmithKline's prescription MDI Ventolin (albuterol) in "terminating an acute episode of airway obstruction but safer at higher doses," Leslie Hendeles, Health Science Center, University of Florida, et al., found. The randomized, cross-over study was conducted on two different nights at a clinical research center. The eight patients were administered albuterol upon waking from asthma symptoms on one night and epinephrine the next. "A study with a larger number of patients is required before epinephrine can be recommended as rescue therapy when prescription beta2-agonist MDI is not accessible," the authors state. The necessity of OTC chlorofluorocarbon-MDIs will be discussed at an advisory panel meeting Jan. 24 (1"The Tan Sheet" Dec. 5, 2005, p. 5)...
Epinephrine study
"Nonprescription epinephrine CFC-MDI is more effective and safer than what many health care professionals believe," a study in the December Annals of Allergy, Asthma & Immunology concludes. Wyeth's Primatene Mist OTC metered-dose inhaler was "nearly" as effective as GlaxoSmithKline's prescription MDI Ventolin (albuterol) in "terminating an acute episode of airway obstruction but safer at higher doses," Leslie Hendeles, Health Science Center, University of Florida, et al., found. The randomized, cross-over study was conducted on two different nights at a clinical research center. The eight patients were administered albuterol upon waking from asthma symptoms on one night and epinephrine the next. "A study with a larger number of patients is required before epinephrine can be recommended as rescue therapy when prescription beta2-agonist MDI is not accessible," the authors state. The necessity of OTC chlorofluorocarbon-MDIs will be discussed at an advisory panel meeting Jan. 24 (1"The Tan Sheet" Dec. 5, 2005, p. 5)...
Epinephrine study
"Nonprescription epinephrine CFC-MDI is more effective and safer than what many health care professionals believe," a study in the December Annals of Allergy, Asthma & Immunology concludes. Wyeth's Primatene Mist OTC metered-dose inhaler was "nearly" as effective as GlaxoSmithKline's prescription MDI Ventolin (albuterol) in "terminating an acute episode of airway obstruction but safer at higher doses," Leslie Hendeles, Health Science Center, University of Florida, et al., found. The randomized, cross-over study was conducted on two different nights at a clinical research center. The eight patients were administered albuterol upon waking from asthma symptoms on one night and epinephrine the next. "A study with a larger number of patients is required before epinephrine can be recommended as rescue therapy when prescription beta2-agonist MDI is not accessible," the authors state. The necessity of OTC chlorofluorocarbon-MDIs will be discussed at an advisory panel meeting Jan. 24 (1"The Tan Sheet" Dec. 5, 2005, p. 5)...