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Ketek® and Liver Failure
According to a safety review conducted by the FDA, there have been 35 Adverse Event Reports (AERs) reports of serious liver toxicity associated with the use of Ketek®. Of these 35 cases that were reported to the FDA, 12 involved liver failure - resulting in 4 deaths – and 23 involved other serious liver injury. There are additional AER reports involving liver problems associated with Ketek® and, in May of 2006, it was suggested that a black box warning (the most serious type of warning) be added to the Ketek® label.
In the midst of these serious safety concerns, Ketek® was being tested in a pediatric population of 4,000 infants and children. The clinical trial was designed to test the efficacy of Ketek® to treat ear infections and tonsillitis. The infants and children ranged in age from 6 months to 13 years and were participating in one of 4 separate trial that were approved by the FDA.
If you or a loved one developed liver disease or failure, or symptoms of liver failure, during or after treatment with Ketek®, please click HERE for information about your potential legal rights.
Symptoms of Liver Disease or Failure
The liver is a vital organ that is located above the stomach in the upper right quadrant of the abdomen:
The liver consists of three main lobes and in its healthy, normal state appears dark red in color. A diseased liver often enlarges or shrink, depending on the nature of the disease.
There are many symptoms associated with the onset of liver disease or failure. Of these, the more common are:
- Jaundice – a yellowing of the skin and whites of the eyes resulting from abnormal levels of bilirubin (a marker of abnormal liver function) circulating in the body;
- Liver Enlargement - a swelling of the liver can produce a feeling of fullness or discomfort in the abdomen;
- Ascites – an accumulation of fluid in the abdomen which can cause shortness of breath and abdominal discomfort;
- Portal Hypertension – the portal vein supplies blood to the liver. Increased blood pressure (hypertension) in the portal vein is an indicator of liver disease.
- Encephalopathy – a deterioration of brain function that can be caused by the presence of toxins that accumulate in the body as a result of liver failure.
If you or a loved one developed liver disease or failure, or symptoms of liver failure, during or after treatment with Ketek®, please click HERE for information about your potential legal rights.
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