From: EXECSEC
Sent: Monday, December 11, 2000 9:18 AM
To: Dockets, FDA
Subject: FW: Docket#OOP-1499/CP1--Lotronex



-----Original Message-----
From: Henney, Jane 
Sent: Saturday, December 09, 2000 10:18 PM
To: EXECSEC
Subject: FW: Docket#OOP-1499/CP1--Lotronex




> ----------
> From: 	Joann Price[SMTP:JAPRICE@POL.NET]
> Sent: 	Saturday, December 09, 2000 10:15:53 PM
> To: 	WoodcockJ@CDER.FDA.gov; JHenney@OC.FDA.gov
> Subject: 	Docket#OOP-1499/CP1--Lotronex
> Auto forwarded by a Rule
> 
Dear Drs. Woodcock and Henney,
I am very distressed at the FDA's request for the withdrawal of 
Lotronex.  I have several patients whose lives have literally been 
changed by this medication.  My patients have been calling me, very 
unwilling to give up this medication, since it has made such a 
tremendous difference in their lives.  There is no alternative for 
these patients.  I have nothing else to offer them.

Although it is disturbing some patients have had significant adverse 
reactions and there have been several deaths (although I understand 
there is no causal relationship established with Lotronex), almost all 
drugs with current FDA approval have been associated with serious side 
effects and deaths.  Again, THERE IS NO ALTERNATIVE FOR MY PATIENTS.  
Nothing has helped them in the past.

I would like to give you the history on one of my patients, Flora C., 
a 53 y.o. WF.  She has suffered with irritable bowel syndrome since 
1974.  She reported diarrhea and abdominal spasms lasting the entire 
morning, everyday, despite the use of Questran and Imodium.  This 
patient could not leave her home in the mornings due to the diarrhea. 
 She could not have taken a daytime job.  She could not come to 
doctor's appointments or do grocery shopping in the morning, etc.  
When she did schedule an afternoon doctor's appointment, she took 
Questran and Imodium, and she was still very fearful she would have 
diarrhea.  This patient was almost a prisoner because of the diarrhea 
and abdominal pain.  She has been on Lotronex since May 25, 2000 
without any side effects.  She recently stated she is "doing extremely 
well on" Lotronex.  She stated, "I HAVE MY LIFE BACK AND I AM SO 
GRATEFUL".  She stated Lotronex "has made all the difference in the 
world" for her, and she is "now able to live a normal life and leave 
her house without fear of episodes of diarrhea".

Another of my patients, Pat G., a 52 y.o. WF, had severe diarrhea with 
urgency and episodes of fecal incontinence.  Diarrhea awakened her 
from sleep.  She had this pattern for 2-3 years.  She had abdominal 
cramping with the diarrhea.  The urgency was so severe, she was 
fearful of being out of the house, since she would need to get to a 
bathroom immediately once the urge to defecate struck.  She has been 
on Lotronex since May 12, 2000.  Lotronex has been working extremely 
well for her, with no problems.  She stated she absolutely refused to 
give up the medication she has, and she is asking for an alternative.

Lotronex has almost miraculously changed the lives of these women, and 
I believe this drug should continue to be available to these women and 
to any other appropriate patient.  I believe the FDA has OVERREACTED 
to the adverse effects some patients have had.  Narcotics have killed 
people in overdoses and have a tremendous addictive potential, as well 
as many side effects.  Anesthetics kill patients.  Digoxin patients 
must be monitored carefully, and some have died due to digoxin.  The 
statins require monitoring of liver enzymes due to potential for liver 
damage.  Many people have suffered bleeding ulcers and death due to 
NSAIDS.  All these drugs, and many more, not only have serious adverse 
side effects, but cause deaths.  Many drugs have precautions in the 
labeling and require careful monitoring of serum drug levels or liver 
enzymes or renal function, etc.  Yet, all these drugs continue to be 
approved and used because they have benefits for patients.

I believe Lotronex has such significant--even life-changing--benefits 
for appropriate patients that it should be continued to be approved.  
There is also no alternative to Lotronex.  Perhaps more detailed 
labeling, both for physicians and for patients, could be instituted.  
I do not believe the use of this drug should be limited to 
Gastroenterologists.  I am a Gynecologist, and I see women, for whom 
this drug is appropriate.  Many appropriate patients who would benefit 
from Lotronex never get to a gastroenterologist.  (My two patients had 
suffered for 26 and 3 years, respectively, without ever having seen a 
gastroenterologist.)  Gynecologists who are responsible can read the 
insert and give the drug only to appropriate patients. Gynecologists 
can handle this responsibility.

I strongly urge the FDA to reconsider the withdrawal of Lotronex.  
This drug has improved patients' lives in an indescribable way, and 
there is no alternative.  The vast majority of patients who have used 
Lotronex have had no adverse events.  This is a very valuable 
medication which has made a tremendous difference in the lives of many 
patients.  I urge you, on behalf of the many patients whose lives have 
been transformed by Lotronex, to give approval for continued use of 
this medication.  Thank you so much for your careful consideration of 
this matter.

Sincerely,

Joann A. Price, M.D.
185 Hamilton Avenue
Watertown, CT 06795-2431