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Ketek® Side Effects Lawsuit

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The popular antibiotic Ketek (Generic: Telithromycin) has been linked to severe liver injuries including Jaundice, Hepatitis, Liver Failure and Death among patients.

If you or a loved one have taken Ketek and developed a serious side effect, you should contact us immediately. You may be entitled to compensation and we can help.

What is the Problem?

Ketek a popular antibiotic manufactured by Sanofi-Aventis, was approved in 2004 for the treatment of respiratory and bacterial infections including, acute bacterial infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. The drug is known generically as telithromycin.

June 30, 2006 –  In an internal FDA memo, FDA investigators described 12 cases of liver failure among Ketek patients. Four patients died, and one required a liver transplant. One patient had taken a single dose of the drug before becoming ill.

January 20, 2006 – Researchers reported that in a North Carolina hospital, three patients that began taking Ketek and subsequently developed severe life-threatening liver problems and liver failure. The first patient required a liver transplant, the second contracted drug-induced hepatitis and unfortunately the third patient died in the hospital.

May 19, 2006 – The Food & Drug Administration released a report connecting Ketek to 12 cases of liver failure, which included four deaths.

Food & Drug Administration Ketek Warning

The FDA has issued safety warnings to the manufacturer of Ketek to add a warning label to the product advising consumers that there have been cases of liver failure linked to the drug.  In addition, there have been accusations that the manufacturers of Ketek submitted flawed information to the FDA regarding one of the manufacturers’ tests in order to get the drug approved. The FDA did not approve Ketek in 2001 and again in 2003 due to the lack safety information on the drugs label.

New England Journal of Medicine – The FDA and the Case of Ketek

In an excellent article published in the NEJM and written by David B. Ross, M.D., Ph.D., he discusses the lessons to be learned from an examination of the events surrounding the approval of Ketek.

Three years ago, the Food and Drug Administration (FDA) approved the drug Ketek (telithromycin), lauding it as the first of a new class of antimicrobial agents that circumvent antibiotic resistance. Since then, Ketek has been linked to dozens of cases of severe liver injury, been the subject of a series of increasingly urgent safety warnings, and sparked two Congressional investigations of the FDA’s acceptance of fraudulent safety data and inappropriate trial methods when it reviewed the drug for approval. As a former FDA physician who was involved in the Ketek review, I believe there are lessons to be learned from an examination of the events surrounding the approval of this product.

Read More: Link to Full Article

Do I have a Ketek Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Ketek lawsuits. We are handling individual litigation nationwide and currently accepting new Ketek side effect cases in all 50 states.

If you or a loved one have taken Ketek and developed a serious side effect, you should contact us immediately. You may be entitled to compensation and we can help.

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