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Ketek Labeling To Include Strong Liver Warning

-June 30, 2006

The FDA and Sanofi-Aventis, the makers of Ketek, have announced that this antibiotic's labeling will now include a strong warning about serious and potentially fatal Ketek liver side effects and other serious injuries. While developing serious Ketek side effects is rare, dozens of people have been seriously injured because of this medication.

The FDA has received at least 14 reports of acute liver failure caused by Ketek. Of these patients, four died due to Ketek liver failure side effects. A fifth patient required a liver transplant. At least 23 other patients have suffered serious liver injuries due to Ketek.

The FDA approved the antibiotic Ketek in 2004 to treat bronchitis, sinusitis, respiratory tract infection, and pneumonia.

According to both the FDA and Sanofi, Ketek's benefits still outweigh its potential risks for most patients. The FDA will continue to monitor Ketek safety and side effects reports to determine if any further action is warranted.

The new Ketek label warns patients and doctors to watch for the development of hepatitis symptoms. These can include:

  Malaise

  Fatigue

  Jaundice

  Anorexia

  Nausea

  Fatigue

Patients who develop these or other liver damage symptoms should cease Ketek treatment immediately and seek medical treatment, which should include a liver function test.

For some patients, Ketek risks outweigh the antibiotic's potential benefits. For example, patients with myasthenia gravis, an autoimmune disorder characterized by fatigue and weakness, should not use Ketek unless no other treatment is available. At least three patients with this condition have developed acute respiratory failure and died because of Ketek use.

This month, Sanofi decided to stop enrolling children in a Ketek study.

In a statement about the recent Ketek warning, Senator Charles Grassley commented: "There are questions about whether this drug [Ketek] 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."

If you or a loved one has suffered a Ketek injury, please contact us to learn more about seeking compensation for your losses and suffering.

 

 

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