Antibiotic Ketek to Carry New Warning Label

Drug maker Sanofi-Aventis has announced its antibiotic, Ketek, will carry a stronger, bold-type label warning of the risk of possible liver damage. The action comes amid growing concerns over the safety of Ketek.  A confidential FDA internal memo on Ketek obtained by ABC News detailed dozens of reports of liver failures, including four deaths in patients who had used Ketek.  The updated label warns patients to discontinue use of Ketek if they experience symptoms of hepatitis, such as fatigue, nausea or liver tenderness. Those with a previous history of hepatitis are advised not to take Ketek at all.

A Sanofi-Aventis statement on the warning label revision said, "This update is based on a rigorous analysis of the available data, including consultation with leading experts to ensure that we had the most informed understanding possible with respect to hepatic and myasthenia gravis adverse events. Based on the in-depth review of the clinical trial and post- marketing data, we continue to believe that the benefits of Ketek outweigh the risks when the drug is used as directed for its approved indications."

Since it was approved by the FDA in 2003 to treat respiratory infections, Ketek has proved to be a highly popular antibiotic, racking up sales of nearly $200 million just last year.  However, the drug has been dogged by controversy after it was learned that key safety tests during clinical trials contained fraudulent data.  The doctor who ran the clinic that enrolled the most patients for the study is serving five years in prison for falsifying patient data on Ketek.

Senator Charles Grassley (R-IA), who is currently investigating the FDA’s handling of Ketek, responded to the new warning label announcement with a statement saying, "There are questions about whether this drug should stay on the market, and there’s great legitimacy to those questions.  Ketek is another example where the FDA accommodated a drug maker and turned a blind eye to serious safety concerns."