From: EXECSEC
Sent: Wednesday, December 06, 2000 12:37 PM
To: Dockets, FDA
Subject: FW: LOTRONEX..a revolutionary drug for the RIGHT patient in a
lower dosage



-----Original Message-----
From: Henney, Jane 
Sent: Wednesday, December 06, 2000 10:59 AM
To: EXECSEC
Subject: FW: LOTRONEX..a revolutionary drug for the RIGHT patient in a
lower dosage




> ----------
> From: 	
> Sent: 	Wednesday, December 06, 2000 10:58:06 AM
> To: 	JHenney@oc.fda.gov
> Cc: 	WoodcockJ@cder.fda.gov
> Subject: 	LOTRONEX..a revolutionary drug for the RIGHT patient in a lower dosage
> Auto forwarded by a Rule
> 
                                                                        
                                                                             
December 5, 2000

                                                                             


Dockets Management Branch
FDA
Department of Health and Human Services
Rm1-23  12420 Parklawn Drive
Rockville, MD. 20857

Dear  Dr. Henney  and Dr. Woodcock,

I am a CRNA working in the operating room at -----------------------------.  I have been a healthcare provider  since 1972 and have 
developed an excellent understanding  of  Pharmacology.

I  have had Irritable Bowel Syndrome for twenty years.  In that time, I have 
been on every available drug prescribed for this hypermotility disorder at 
one time or another.
In addition,  I have tried every conceivable dietary modification suggested 
to me by  the Gasroenterologists who have treated me, but to no avail.  I 
obtained little or no relief UNTIL I  TOOK LOTRONEX in MARCH,  2000.

Lotronex, the first medication of it's kind, RESTORED A QUALITY OF LIFE that 
I had not experienced in 20 years.  At first, I had some difficulty with 
constipation BUT I quickly found that reducing the dosage to 1 mg/day in 
combination with a high fiber diet and 8-10 8oz glasses of water a day 
completely eliminated this side effect and produced an extremely good result.

I am shocked and dismayed that the FDA asked Glaxo Welcome to remove this 
revolutionary drug  from the market without first attempting to make some 
adjustments in dosage and mandate  more effective patient and clinician 
education.  In addition, Use of this drug should be restricted to patients 
with  a long standing  and well documented cases of IBS by a 
gastroenterologist.

Lotronex is a very effective drug .  Use of it has freed me from the "life 
limiting" symtoms of  Irritable Bowel Syndrome and allowed me to be a more 
productive and functional individual.  

As a clinician, I am well aware of the "rare" but serious side effects 
reported in connection with the use of Lotronex.    As you know, many drugs 
have  "rare" but serious side effects but they remain on the market with 
appropriate warning information and modifications when necessary. 

In conclusion,  banning the use of Lotronex so quickly after it's approval is 
an enormous disservice to women with IBS.  Please consider  the 
reintroduction of this drug in a lower dosage  with appropriate high 
fiber/high fluid dietary modification.

Thank you very much                                 
                                                           Sincerely,