Docket Management
Docket: 00N-1269 - Labeling for Human Prescription Drug/Biologic Products
Comment Number: EC -1

Accepted - Volume 2

Comment Record
Commentor Ms. Julana Powell Date/Time 2001-02-19 09:06:17
Organization Ms. Julana Powell
Category Individual

Comments for FDA General
1. General Comments I am writing to express my concerns regarding a specific type of medication the FDA recently took off the market. The medication is called Hismanal. I have an allergic condition called hives,and I've had this condition since I was approximately five years old. Every so often, usually in the fall/winter months they flare up. Years ago, when I was an undergrad in college, I took Hismanal along with Hydroxyzine. In the year 2000, last year, they began acting up (my hives) really bad. I went to my dermetologists and she informed me that Hismanal was taken off the market due to people taking it incorrectly and dying as a result. Please don't get me wrong, I sympathize with the loss of lives as a result of taking the medication incorrectly. But what about those individuals who read the instructions carefully,take the proper dosage, etc? I am one of those people. My hives have yet to go away. I failed to mention that after taking the Hismanal in the past, it worked so great, that it sometimes terminated my hives for months at a time. Boy was that a relief! Hives is so uncomfortable to me, that sometimes I wish I could just cut them off of my body. I don't want you guys to misinterpret that comment,I would never willingly inflict harm upon myself, I am in no way suicidal. Yet, you must understand the discomfort I go through day and night with my hives. I am currently taking the Hydroxyzine and Zrytec. However, after finding out I am pregnant, my doctor wants me to only continue taking the HCL. My question: I want to know if there is anyway, at least after my pregnacy or possibly even during it, if it's safe, if I could continue taking the Hismanal? As I stated before, I have had nothing but success with the aforementioned medication in the past. Could you guys please allow me to be able to receive the Hismanal for my hives? I really need help, and only the FDA has the power to help me. Thank you so much for you time. Julana

EC -1