http://www.fda.gov/medwatch/safety/2000/safety00.htm#quick
New Safety Information Summaries 2000
Summaries of "Dear Health Professional" letters and other safety notifications of which MedWatch is aware. Listed in reverse chronological order...Current as of: September 27, 2000
Quick Reference: ( Click on the type of medical product to go directly to those products and then click on the product of interest to go to the summary for that product.)
NOTE: These summaries do not include all of the information contained in the letter or other notification; therefore, to see the full text, click on the underlined type of notification at the end of each summary.
The following categories are listed.
Biologics - Dietary Supplements - Drugs - Medical Devices - Other
1.) Click: "Drugs"
2.) SCAN through these drugs to see if you are currently taking any other drugs besides Lotronex.
[ NOTE: Propulsid ( Cisapride ) is listed. I remember having taken this drug at the time I was being treated for either GERD or H. Pylori ( or both at the same time ) a few years ago.]
3.) Click: " Lotronex ( alosetron hydrochloride ) Tablets " ( Posted 8/24/2000 )
4.) Click on each of the following to read:
August 24, 2000 - scroll down to: " Dear Health Care Professional " Letter
August 24, 2000 - scroll down to: " Dear Pharmacist " Letter
August 24, 2000: " LOTRONEX ( alosetron hydrochloride ) "
August 24, 2000: Patient Medication guide ( I posted this article today, September 29, 2000. )
August 30, 2000: Questions and Answers - BE SURE TO READ THIS!!!
August 24, 2000: FDA CREATES MEDICATION GUIDE FOR LOTRONEX ( I posted this article today, September 29, 2000. )
"The updated labeling for health professionals states that Lotronex treatment should not be started when women are constipated; and it informs prescribers that Lotronex is now contraindicated in women with:
1.) a history of INTESTINAL OBSTRUCTION, stricture, toxic megacolon, gastrointestinal perforation, and/or ADHESIONS;
2.) a history of ischemic colitis;
3.) active diverticulitis; or
4.) current Crohn's Disease or ulcerative colitis, or a history of such a disease."