> [Original Message] > From: CDER MEDWATCH LISTSERV <[EMAIL PROTECTED]> > To: <[EMAIL PROTECTED]> > Date: 2/12/2007 4:05:40 PM > Subject: FDA - MedWatch - Ketek (telithromycin) Changes to Prescribing information that Include the Removal of Two Previously Approved Indications, a BOXED WARNING, and a Patient Medication Guide > > MedWatch - The FDA Safety Information and Adverse Event Reporting Program > > FDA and Sanofi-Aventis notified healthcare professionals of revisions to > the prescribing information, including a BOXED WARNING and a new Patient > Medication Guide, for the antibiotic Ketek. Two of the three previously > approved indications, acute bacterial sinusitis and acute bacterial > exacerbations of chronic bronchitis, were removed from the prescribing > information because the balance of benefits and risks no longer support > approval of the drug for these indications. Ketek will remain on the > market for the treatment of community acquired pneumonia of mild to > moderate severity. In addition, warnings were strengthened for > hepatotoxicity (liver injury), loss of consciousness, and visual > disturbances. The BOXED WARNING states that Ketek is contraindicated in > patients with myasthenia gravis. The Patient Medication Guide, which > must be distributed to all patients, informs them about the risks of the > drug and how to use it safely. > > Read the complete MedWatch 2007 Safety summary, including links to the > FDA Press Release and Drug Information Page and the Manufacturer's > revised prescribing information and Medication Guide for Ketek regarding > this issue 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
