Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -193

Accepted - Volume 298

Comment Record
Commentor Dr. Patrick Gleason Date/Time 2003-03-10 15:32:02
Organization University of Minnesota
Category Health Professional

Comments for FDA General
Questions
1. General Comments To Whom it May Concern: I commend the FDA for opening discussion on the Ephedrine Alkaloids containing products. It is my professional opinion as a pharmacist who regularly counsels patients on their medications including herbal/natural products that patients are unaware of the risks associated with ephedrine alkaloids and herbal/natural products in general. Specifically, ephedrine alkaloids are known alpha-agonists, meaning they increase constriction of blood vessels increasing systemic vascular resistance and the work of the heart and in doing so raising blood pressure. The long-term consequences of chronic use appear to very high, therefore, a warning should accompany these products including but not limited to warning patients that increases in blood pressure can occur, risk of congestive heart failure or worsening current congestive heart failure, risk of stroke, and heart attack. I have on more than one occassion discourage use of ephedrine alkaloids for weight loss (as recommended by an herbalist) in patients with a history of heart attack and/or stroke. Lacking a warning, I am very concerned there are many patients out there that are taking ephedrine (ephedra) like products for reasons like weight loss that have medical contraindications to using a alpha agonist product. The efficacy of ephedrine products for weight loss have not been established, especially long-term therapy and the risks of alpha-agonists (ephedrine) are very clear in patients with cardiovascular disease. Therefore, at the mimimum a warning label should be required and the studies done to establish long-term safety and efficacy. Lastly, I would like to reiterate that patients are unaware of herbal/natural products risks and benefits unless the patient specifically seeks out a pharmacist or other medical professional who have spent the time to educate themselves about these products. Unfortunately, herbalist and health food store employees are incited to sell a product and experience dictates that patients do not receive even the major risks of these products from herbalists or other health food store employees. Thank you for your time considering the risks and benefits of ephedrine alkaloids. Most Cordially Submitted, Patrick P. Gleason, Pharm.D., BCPS Clinical Assistant Professor University of Minnesota




EC -193