Ketek (Generic: Telithromycin)

At this time, Pulaski Law Firm, P.L.L.C. has successfully resolved or settled all cases wherein our clients who sustained injuries as a result of the ingestion of Ketek.

Problems associated with the antibiotic Ketek (Generic: Telithromycin) were first reported in January of 2006 when researchers released information about three cases of severe liver problems in patients at a North Carolina hospital. After being treated with Ketek, the patients began to suffer health complications and had to be hospitalized. The liver problems aggravated by the use of Ketek claimed the life of one of the patients, prompting a Federal investigation. Federal regulators reported they were examining an unknown number of U.S. cases involving Ketek and would be consulting with overseas counterparts.

Manufactured by Sanofi-Aventis, Ketek was approved in 2004 for the treatment of acute bacterial infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. After the reports of severe liver problems in patients taking Ketek, the FDA began to examine their databases for any other reports of similar liver problems in patients who were prescribed Ketek.

It is the opinion of Dr. John Hanson, a doctor at the liver transplant center at Carolinas Medical Center, that all doctors should be alerted to a possible link between liver damage and the use of Ketek. The Carolinas Medical Center in Charlotte, N.C., also struggled to treat patients suffering from complications with Ketek. One patient died, another had to receive a liver transplant, and the third contracted drug-induced hepatitis after being treated with Ketek. Fortunately, the patient was able to recover from hepatitis after treatment of Ketek was stopped.

FDA Action

After further investigations, the FDA was able to connect twelve cases of liver failure to the use of the antibiotic Ketek. Four patients of the twelve lost their lives due to the liver problems. The FDA confronted Sanofi-Aventis, the manufacturer of Ketek, to add a warning label to the drug. Back in 2001 and 2003, the FDA refused to approve Ketek due to the lack of safety information on the label of the drug. Although it was eventually approved, the U.S. government was wary of the decision after accusations arose questioning the validity of one of the manufacturer’s tests.

Ketek Lawyer, Ketek Attorney
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