KETEK NEWS
The Nations Law Firm represents people who have been injured by dangerous medications, such as Ketek. If you or someone you know has used Ketek and has suffered from liver damage or other serious side effects, please contact our offices for a free consultation with one of our pharmaceutical attorneys.
FDA WARNS DRUG COMPANY FOR FAILING TO ACT ON KETEK FRAUD
Clinical Investigators accused of submitting tainted Ketek data
By Cindy L. Nations
October 26, 2007
This week the FDA sent a 9-page Warning Letter to drug company Sanofi-Aventis notifying them of "objectionable conditions" found during an FDA investigation into Ketek clinical studies. The drug company was accused of knowingly submitting clinical drug study data that was obtained by investigators who had committed "multiple and significant violations of FDA regulations ... that affected the integrity of data submitted." The warning letter gives Sanofi-Aventis 15 days to provide the FDA with a written response addressing the list of deficiencies and says, "FDA also plans to meet with your company."
Source: Law Offices of Howard L. Nations
www.howardnations.com
FDA SAFETY ALERT
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Ketek
Source: U.S. Food & Drug Administration
February 12, 2007
FDA PRESS RELEASE
FDA Announces Label and Indication Changes for the Antibiotic Ketek
The Food and Drug Administration (FDA) today announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by patients. The changes include the removal of two of the three previously approved indications -- acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis -- from the drug's label. (More ...)
Source: U.S. Food & Drug Administration
February 12, 2007
KETEK DRUG INFORMATION PAGE
http://www.fda.gov/cder/drug/infopage/telithromycin/default.htm
Source: U.S. Food & Drug Administration
February 12, 2007
FDA Patient Information Sheet
Telithromycin (marketed as Ketek)
July 21, 2006
http://www.fda.gov/cder/drug/InfoSheets/patient/telithromycinPIS.HTM
Ketek (Telithromycin) Revised Label
June 29, 2006
http://www.fda.gov/cder/foi/label/2006/021144s011lbl.pdf
FDA Public Health Advisory
June 29, 2006
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01401.html
FDA Public Health Advisory
January 20, 2006
http://www.fda.gov/cder/drug/advisory/telithromycin.htm
FDA Questions & Answers about Ketek
January 20, 2006
http://www.fda.gov/cder/drug/infopage/telithromycin/qa.htm
FDA MedWatch Safety Alert
January 20, 2006
http://www.fda.gov/medwatch/safety/2006/safety06.htm#Ketek
Brief Communication: Severe Hepatotoxicity of Telithromycin: Three Case Reports and Literature Review
Kimberly D. Clay, MD, MPH; John S. Hanson, MD; Scott D. Pope, PharmD; Richard W. Rissmiller, MD; Preston P. Purdum III, MD; and Peter M. Banks, MD
Annals of Internal Medicine Online
21 March 2006 | Volume 144 Issue 6 |
http://www.acponline.org/journals/annals/hepatotoxicity.htm
Editorial: Telithromycin
Michelle Turner, Pharm.D.; G. Ralph Corey, M.D.; Elias Abrutyn, M.D.
Annals of Internal Medicine Online
21 March 2006 | Volume 144 Issue 6 |
http://www.annals.org/cgi/reprint/144/6/447.pdf
