From: EXECSEC
Sent: Thursday, December 07, 2000 7:19 AM
To: Dockets, FDA
Subject: FW: LOTRONEX



-----Original Message-----
From: Henney, Jane 
Sent: Wednesday, December 06, 2000 4:41 PM
To: EXECSEC
Subject: FW: LOTRONEX




> ----------
> From: 	
> Sent: 	Wednesday, December 06, 2000 4:33:02 PM
> To: 	JHENNEY@OC.FDA.GOV
> Subject: 	LOTRONEX
> Auto forwarded by a Rule
> 
Dear Jane,

I am a former Lotronex patient.  I am curious as to whether or not the FDA
and/or Glaxo Welcome will be re-evaluating this drug to go back on the
market.  I was on this drug since the end of April.  I experienced slight
constipation in the beginning.  After I adjusted the medication, I was
great.  I had no flare ups, no urgency to use the bathroom.  I was well
informed as to the side effects and what I needed to be looking for (ex.
Bloody stool, can't move bowels for 2-3 days, etc.).  I was also seeing my
Gastro Dr. every three months.  I feel that this drug has helped many women,
now we are back to square one.  Since last Thursday, I have been on two
different medicines, due to side effects from them.  I don't know what other
drug is going to give me the normal life I had on Lotronex.  I would hope
that you would look into the drug a little more thoroughly.  I think that if
your Dr. monitors you very closely, there shouldn't be any problems.  I put
on Levsin/Levbid. I had blurred vision, problem urinating, light
sensitivity, headache, and very bad dry mouth.  I contacted my Dr.
immediately and she told me to stop and took me off the drug and gave me
something else.  I think that if the patients on Lotronex were monitored,
this would not have had to been taken off the market.

Unless you have lived with IBS, you cannot appreciate how much this drug has
made my life livable again.

Any consideration would be greatly appreciated.

Thanks,






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