Ketek (Telithromycin) Breaking News & Warnings-
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Ketek has been linked to a variety of liver ailments that may lead to death. Below you can read breaking news stories regarding Ketek and its manufacturer, Sanofi-Aventis. If you or a loved one has suffered after using Ketek, fill out this simple form for a free lawsuit case evaluation from an experienced dangerous drug attorney.
Antibiotic Ketek (Telithromycin) Linked to Severe Hepatotoxicity
August 2006 (MedicineNews.net)
According to an article published in the Annals of Internal Medicine in 2006,
researchers at the Carolinas Medical Center in Carlotte, NC, reported that three
patients experienced serious liver toxicity following administration of
Ketek.
All three patients had previously been healthy and were not using
other prescription drugs.
FDA Completes Safety Assessment of Ketek New Safety Information to be Added to Product Labeling
June 29th, 2006 (www.fda.gov)
The warning, which Ketek’s manufacturer is adding to the drug’s labeling, results from FDA’s vigilant monitoring of all drugs after their introduction to the market. When the agency approved the drug in 2004, based on data in the marketing application, the risk of liver injury with Ketek was similar to that of other marketed antibiotics. A safety evaluation conducted one year after approval was consistent with this. However, as the product entered into wider use, FDA’s adverse event monitoring system received some reports of serious liver problems in patients taking Ketek, including some cases of acute liver failure leading to death or requiring liver transplantation.
Sanofi, FDA in talks on Ketek label after concerns
May 19th, 2006 (today.reuters.com)
French drug maker Sanofi-Aventis and U.S. regulators are discussing potential revisions to prescribing instructions on antibiotic Ketek after safety reviewers said a strong warning may be needed about cases of liver failure, the Food and Drug Administration said on Friday.
The company and the FDA confirmed the talks after the Wall Street Journal cited an internal FDA report linking Ketek to 12 cases of liver failure, including four deaths.
FDA probing death linked to new antibiotic
January 20, 2006 (msnbc.msn.com)
Other cases of severe liver damage reported in patients taking drug
WASHINGTON - Researchers reported Friday three cases of severe liver problems, including one death, in patients at a North Carolina hospital after they began taking a novel antibiotic.
Federal regulators said they were reviewing an unknown number of U.S. cases involving the drug, telithromycin, and were consulting with their counterparts overseas.
Sanofi Drug Linked to Patient Death, Liver Failure in Report
January 20, 2006 bloomberg.com
Jan. 20 (Bloomberg) -- Sanofi-Aventis SA's antibiotic Ketek, used to treat lung and sinus infections, may be linked to liver damage that resulted in the death of one patient and transplant surgery for another, according to a medical journal report.
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see also:
Ketek Tablets
Ketek Tablets - FDA AdvisoryThe Danger behind Ketek - A new FDA warning
Ketek Symptoms
Ketek Symptoms - Know if You are ExposedThe Danger behind Ketek - A new FDA warning
News & Warnings
Breaking Ketek (Telithromycin) News from Dangerous Drug AttorneysBreaking Ketek News & FREE Lawsuit Evaluation from Ketek Attorneys
