MedWatch: The FDA Medical Products Reporting Program

From: Helen Dynda (olddad66@runestone.net)
Fri Sep 29 14:36:23 2000


Important Safety Information - 2000[] MedWatch: THE FDA MEDICAL PRODUCTS REPORTING PROGRAM

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."


Enter keywords:
Returns per screen: Require all keywords: