From: EXECSEC
Sent: Wednesday, December 06, 2000 7:22 AM
To: Dockets, FDA
Subject: FW: Lotronex Withdrawal



-----Original Message-----
From: Henney, Jane 
Sent: Tuesday, December 05, 2000 11:00 PM
To: EXECSEC
Subject: FW: Lotronex Withdrawal




> ----------
> From: 	
> Sent: 	Tuesday, December 05, 2000 10:59:45 PM
> To: 	jhenney@oc.fda.gov; senator@feinstein.senate.gov
> Subject: 	Lotronex Withdrawal
> Auto forwarded by a Rule
> 
I am a physician who is familiar with patients with Irritable Bowel Syndrome 
and whose wife has suffered with IBS for 35 years.  It is a severely 
disabling disease which significantly downgrades the quality of life of the 
patient.  For years we Doctors have told these patients that there is nothing 
we can do for them, and that they should learn to live with it, it is "all in 
their head", watch your diet, eat fiber, avoid stress, try Valium, etc.  None 
of this helped them.

When Lotronex was introduced, these patients finally had a medicine which has 
dramatically improved their life, and proved that IBS is not a disease that 
is "all in their head".  In my wife's case (and many others), her chronic 
abdominal pain and diarrhea have disappeared.  She can eat foods never before 
tolerated.  She can go through the day without the constant threat of 
explosive diarrhea.  She cried when she read that Lotronex was suddenly 
withdrawn by the FDA.

The possible side effects and precautions and drug interactions were carefu
lly explained to her and put in writing.  THERE ARE ALWAYS SOME FEW PATIENTS 
WHO ARE GOING TO ADVERSELY REACT TO ANY MEDICINE, EVEN ASPIRIN.  Should this 
mean that all IBS patients must be denied the overwhelming benefits only 
available to them from Lotronex?  My medical opinion is NO!  I see the near 
miraculous benefits of this drug to many patients.  As head of the FDA, you 
are aware mainly of the possible complications to a very few.

I ask that the FDA reconsider the total and sudden withdrawal of Lotronex 
from the market.  It is the ONLY drug available that can offer almost total 
relief from the chronic and disabling  disease of IBS.

Thank you for your attention.

Sincerely,