Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1350

Accepted - Volume 326

Comment Record
Commentor Mr. Thomas Moverman Date/Time 2003-04-04 15:04:51
Organization Lipsig, Shapey, Manus & Moverman, P.C.
Category Other

Comments for FDA General
1. General Comments FROM: Thomas Moverman RE: EPHEDRINE [Cytodyne's Xenadrine RFA-1] CASE For about one month prior to and on July 17, 2002, Mrs. Anna B. ingested a dietary supplement made and sold by Cytodyne Corp., known as XENADRINE RFA-1. Mrs. B, a 46 year old women, was trying to lose weight. She resides in New York State with her husband and their four sons, ages 3 - 13 years old. Her routine medical care was provided by her ob/gyn who saw her for about two years, primarily for upper respiratory infections, colds and coughs. She had no prior known cardiovascular disease, neurological conditions or chronic illnesses. She used Cytodyne's product XENADRINE RFA-1 pursuant to the label directions and took 2 capsules twice a day for about one month. As a result of taking this ephedrine and caffeine-containing product, Mrs. B suffered cardiac arrest and ventricular fibrillation at home. She was discovered by her children who telephoned 911 and paramedics arrived at her home at about 10:10 A.M. on July 17, 2002. She was found to be pulseless and apnic on arrival of EMS. After use of an AED for defribillation, together with ALS care, she regained pulses and blood pressure. However, due to cerebral anoxia suffered prior to the cardiac resuscitation by the EMS personnel, she entered and is currently remains in an irreversible coma.

EC -1350