LegalView Reports on Potential Link Between Children TransWorldNews (press release), GA - Nov 12, 2008 Ketek has been linked to liver failure as well as several hospitalizations and deaths among patients. It is important for a patient of Ketek to discuss ...
LegalView Brain Injury Site Reports Department of Veteran Affairs ... PR-CANADA.net (press release), Montenegro - Aug 4, 2008 The prescription drug Ketek was allegedly linked to liver damage and to an increased risk of jaundice. In April 2008, the US Food and Drug Administration ...
LegalView Offers Mesothelioma Blog Readers Details of ... PR-CANADA.net (press release), Montenegro - Aug 4, 2008 Reports have tied the antibiotic with the possibility of severe liver damage among patients. Additional Ketek side effects may also be considered dangerous ...
The National Medicinal Drug Policy and the FDA Model The Island (subscription), Sri Lanka - Jul 28, 2008 In the meantime, "Ketek has now been linked to 18 deaths and at least 134 cases of liver damage, according to an independent analysis using FDA data. ...
LegalView Unveils Details of a Breakthrough Mesothelioma TransWorldNews (press release), GA - Jul 28, 2008 The antibiotic has been linked to severe liver damage among patients and has allegedly been the cause of nearly 18 deaths, according to FDA reports. ...
Doctor analyzes magazine's list of drugs to avoid KATU, OR - Jul 17, 2008 According the Men's Health article, Celebrex has been linked to increased risks of stomach bleeding, kidney trouble, and liver damage. ...
Source: Google News
The FDA and the Case of Ketek - DB Ross - New England Journal of Medicine, 2007 - content.nejm.org ... trial comparing the in- cidence rates of hepatic, cardiac, and visual ... to the US market,
the first death from Ketek-associated liverfailure ? in a ...
Telithromycin and Acute Liver Failure - DJ Graham - New England Journal of Medicine, 2006 - content.nejm.org ... the US market by the FDA because of the increased risk of acute liverfailure. ... C.
Medical officer safety review of NDA 21-144: teli- thromycin (Ketek), March 31 ...
[BOOK] Pocket Book of Infectious Disease Therapy - JG Bartlett - 2005 - books.google.com ... ANTIMICROBIAL AGENTS FOR SPECIFIC PATHOGENS 18 ANTIMICROBIAL DOSING REGIMENS IN
RENAL FAILURE ? 41 USE OF ANTIMICROBIAL AGENTS IN HEPATIC DISEASE 60 ADVERSE ...
Drug-induced liver injury in 2007. W Norris, AH Paredes, JH Lewis - Current Opinion in Gastroenterology, 2008 - co-gastroenterology.com ... with 96% reporting no symptoms consistent with hepatic failure. ... no or low risk of
developing liver toxicity ... box warning for telithromycin (Ketek; Sanofi-Aventis ...
Telithromycin Use and Spontaneous Reports of Hepatotoxicity. - DD Dore, JR DiBello, KL Lapane - Drug Safety, 2007 - drugsafety.adisonline.com ... Hepatic side-effects of antibiotics. ... Lawmakers demand answers about Ketek from FDA,
2006[online]. ... Results of a prospective study of acute liverfailure at 17 ...
Community acquired pneumonia POF CAP - Clin Evid, 2006 - clinicalevidence.bmj.com ... alert for Ketek (telithromycin): The FDA issued a safety alert about the risk of
serious liver injury and liverfailure from the use of Ketek (telithromycin). ...
drug hepatotoxicity. CY CHANG, TD SCHIANO - Alimentary Pharmacology & Therapeutics, 2007 - pt.wkhealth.com ... hepatotoxicity suggested that the type of hepatic injury observed ... 3% probability
of a severe (death or liver transplantation) outcome ... Telithromycin (Ketek) TOP. ...
[CITATION] Canada: May Be Tie Between Sanofi's Ketek, Liver Harm T Month, P Months
Source: Google Scholar
Antibiotic Ketek linked to two cases of liver failure and implicated in a third case of hepatitis
Three case reports of liver problems after taking the antibiotic Telithromycin ( Ketek ) are reported in Annals of Internal Medicine.
Researchers at Carolinas Medical Center in Charlotte, N. C., say that one of the patients died; one required and received a liver transplant; and the third recovered from drug-induced hepatitis after the antibiotic was stopped.
" These cases could represent an unusual clustering of a rare, idiosyncratic drug reaction at one medical center," said John S. Hanson, an author and hepatologist with the Liver Transplant Center at Carolinas Medical Center.
" However, the severity of liver injury in two of our patients warrants this report in the medical literature and will alert other physicians to this possible link with Telithromycin."
Hanson said that, despite the three reports, " At this point, there is not enough data to indicate major changes in prescribing habits."
All cases have been referred to the FDA's Adverse Event Reporting System ( AERS ).
Patients taking Ketek should report symptoms such as malaise, weakness, or jaundice to their prescribing physicians.
Telithromycin was approved by the U.S. Food and Drug Administration in 2004 to treat acute bacterial infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia.
Telithromycin, an antibiotic derived from the macrolide class of antibacterial agents, appears effective against some pneumonia strains resistant to other older antibacterials such as penicillin.
In the three cases described in the Annals of Internal Medicine article, liver problems were observed after the patients began taking Telithromycin. The reports do not prove that the antibiotic caused the liver impairment. But, in the article, the authors advise "caution in prescribing this drug pending further postmarketing surveillance data."
Patients in two of the three cases reported some use of alcohol, although no prior liver damage had been noted. Authors say that the relationship between Telithromycin and alcohol use "warrants further study."
