Docket Management
Docket: 00N-1269 - Labeling for Human Prescription Drug/Biologic Products
Comment Number: EC -13

Accepted - Volume 3

Comment Record
Commentor Mrs. M Bowman Date/Time 2001-04-27 14:32:10
Organization Mrs. M Bowman
Category Individual

Comments for FDA General
1. General Comments Read of potential for Allegra to be released as an over the counter medication. As it is, there is insufficient warning on the drug for patients. As advised by an allergist and pharmacist, the drug is a derivative of Seldane. Both act on certain transmitters. Both have caused severe problems with anxiety, inability to cope with every problems, and depression. My allergist has advised that these problems happen with a small percentage of patients; but the problem is that these side affects are not on the warning labels, and if this drug is made available over the counter, consumers won't understand the impact on their lives. Once Allegra had cleared my body, the depression, anxiety, and inability to cope disappeared and have not returned. This drug may be an effective treatment for allergies, but its impact cannot be understated. The side affects were about to send me to other specialists unnecessarily.

EC -13