> [Original Message] > From: CDER MEDWATCH LISTSERV <[EMAIL PROTECTED]> > To: <[EMAIL PROTECTED]> > Date: 3/26/2007 3:18:31 PM > Subject: FDA MedWatch-KETEK telithromycin) Dear Healthcare Professional letter issued re: safety related labeling changes > > MedWatch - The FDA Safety Information and Adverse Event Reporting Program > > Sanofi-aventis issued a Dear Healthcare Professional letter for KETEK > telithromycin). The label has been revised to add a boxed warning and > contraindication for myasthenia gravis patients. In addition, the > indications for the treatment of acute exacerbation of chronic > bronchitis and acute bacterial sinusitis have been removed from the > labeling. In prescribing KETEK, it is important for healthcare > professionals to inform and discuss with patients the four highlighted > toxicities: exacerbation of myasthenia gravis, hepatotoxicity, visual > disturbances, and loss of consciousness. A Medication Guide has been > developed that replaces the Patient Information section of the US > prescribing information for KETEK, to better inform and educate > patients. The Medication Guide must be provided by pharmacists to > patients when KETEK is dispensed. Healthcare professionals > should advise patients to read the medication guide prior to taking > KETEK. > > Read the complete MedWatch 2007 Safety summary, including a link to the > Dear Healthcare Professional letter and the previous February 12 FDA > MedWatch alert, at: > > http://www.fda.gov/medwatch/safety/2007/safety07.htm#Ketek > > _________________________________________________________________ > > 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
