From: EXECSEC
Sent: Thursday, December 07, 2000 9:04 AM
To: Dockets, FDA
Subject: FW: Lotronex


-----Original Message-----
From: Henney, Jane 
Sent: Thursday, December 07, 2000 7:57 AM
To: EXECSEC
Subject: FW: Lotronex





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From:  
Sent:   Thursday, December 07, 2000 7:56:42 AM
To:     WOODCOCKJ@CDER.FDA.GOV
Cc:     JHENNEY@OC.FDA.GOV
Subject:        Lotronex
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Dear Drs. Woodcock and Henney:
I have been informed that the FDA has requested that Lotronex be withdrawn from the market.  I have had a severe irritable bowel syndrome condition for about 3 1/2 years.  This condition started when I started taking Provochol which I stopped after a couple of months because of IBS.  Unfortunately, even though it got somewhat better it still continued.  I started taking Lotronex last June adding it to the Dicyclomine I was already taking twice a day for the condition.  Lotronex has given me back my quality of life.  I have none of the adverse events that I was told about and I would ask the FDA to reconsider its decision.  When my supply of Lotronex is gone I'm dreading going back to living like I did before.  Thank you for your consideration.