2005N-0374 Use of Ozone-Depleting Substance: Essential-Use Determination of Over the Counter Epinephrine Metered-Dose Inhalers
FDA Comment Number : EC2
Submitter : Mrs. Annette Zampelli Date & Time: 12/19/2005 01:12:42
Organization : Hershey Medical Center
Category : Health Professional
Issue Areas/Comments
I do not believe an extenstion to the makers of CFC epinephrine should be granted. I do not feel this is a safe medication and should never have been made available OTC. It is not approved for the treatment of asthma in the national guidelines. Having the option to purchase this medication OTC simply provides an opportunity for someone not to seek healthcare for the appropriate treatment of asthma and be at risk for sudden death. There continues to be too many people in our country dying annually of asthma due to lack of proper care. I feel part of the blame lies with this medication option. This is our chance to have the medication removed from the market, which may force non compliant asthmatics to seek the appropriate emergency medical care.