SINCE WE SEEM TO HAVE A BUNCH OF DRUGGIES HERE-KINDA REMIINDS ME OF THE ' 60 'S - I SEND THESE OUT FROM TIME TO TIME IF I THINK SOMEONE OUT THERE MIGHT BE INTERESTED.
BOOB > [Original Message] > From: CDER MEDWATCH LISTSERV <[EMAIL PROTECTED]> > To: <[EMAIL PROTECTED]> > Date: 3/30/2007 3:05:01 PM > Subject: FDA - MedWatch - Zelnorm (tegaserod maleate)- Product Market Withdrawal - Study Results Showed Patients on Drug Had Higher Risk of Serious Cardiovascular Adverse Events > > MedWatch - The FDA Safety Information and Adverse Event Reporting Program > > FDA notified healthcare professionals and patients that Novartis has > agreed to discontinue marketing Zelnorm, a drug used for the short-term > treatment of women with irritable bowel syndrome with constipation and > for patients younger than 65 years of age with chronic constipation. FDA > analysis of safety data pooled from 29 clinical trials involving over > 18,000 patients showed an excess number of serious cardiovascular > adverse events, including angina, heart attacks, and stroke, in patients > taking Zelnorm compared to patients given placebo. Patients taking > Zelnorm should contact their healthcare professional to discuss > treatment alternatives and seek emergency medical care if they > experience severe chest pain, shortness of breath, sudden onset of > weakness or difficulty walking or talking, or other symptoms of a heart > attack or stroke. Healthcare professionals should assess their patients > and transition them to other therapies as appropriate. > > Read the complete MedWatch 2007 Safety summary, including a link to the > FDA Public Health Advisory regarding this issue at: > http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zelnorm > > _________________________________________________________________ > > To ensure delivery of these timely alerts to your in-box and prevent rejection of the notice by a spam filter, please add our MedWatch address, [EMAIL PROTECTED], to your address book. > > Thank you for using FDA MedWatch as a trusted source for timely safety information on drugs, devices and diagnostics regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch and this e-mail notification process. They can learn more and subscribe to the e-list at http://www.fda.gov/medwatch. > > To send a comment or question to the MedWatch program: http://www.fda.gov/medwatch/feedback.htm > > To unsubscribe from this listserve: > https://list.nih.gov/cgi-bin/wa?SUBED1=medwatch&A=1
