Liver Transplants
A liver transplant is the surgical removal of a diseased liver
and replacement with a healthy liver. A liver transplant is required
at end-stage liver disease, which involves reduced liver function,
muscle loss, encephalopathy, signs of portal hypertension fatigue,
poor blood clotting ability and jaundice. Many liver diseases
can necessitate a liver transplant. There are two main types
of liver disease: diseases caused by viruses (usually Hepatitis
B and C) and diseases caused by alcohol and those caused by problems
concerning the bile ducts (primary biliary cirrhosis and primary
sclerosing cholangitis).
Prior to liver transplant, a team evaluates potential liver recipients.
After the evaluation, a patient is placed on the liver transplant
waiting list with UNOS (United Network for Organ Sharing). The
wait depends on the patient blood type, size and general medical
condition.
Livers are obtained from several sources. Most often the liver is obtained from a seriously injured donor (a person diagnosed as "brain dead" but whose other organs and systems are functioning properly). There is a shortage of donor livers and unfortunately the waiting time is increasing every year. Perhaps hundreds of people die each year who might have survived had a healthly liver been available.
With cadaveric donor organs, the transplant center gets a
liver offer from UNOS for a specified patient. They notify the
patient in need and admit the person to the hospital. The donor
liver and patient are coordinated. During the 6-8 hour operation,
the diseased liver is removed and the healthy liver is put in
its place. After the operation, the patient must take medication
to prevent the body from rejecting the newly transplanted liver.
A person generally recovers in several weeks and patients usually
go on to lead healthy, normal lives.
How Does Rezulin Cause Liver Damage?
The drug was used to treat Type 2 diabetes, which usually comes on in adulthood and is the most common form of the disease. The Merck Manual -standard reference recognizes troglitazone the active ingredient in Rezulin (in 200-800 mg doses once a day) as capable of causing "serious hepatotoxicity."
Rezulin (troglitazone) is one of several anti-hyperglycemic drugs or "glitazones" which are known as thiazolidinediones. These drugs are insulin-sensitizers that improve insulin sensitivity in skeletal muscle and suppress hepatic glucose output. The only thiazolidinedione available in the United States is troglitazone -of which Rezulin is one type. According to the standard medical text, troglitazone "has potentially idiosyncratic hepatotoxicity."
These drugs have been known to be "an important cause of liver damage." Some drugs cause direct toxicity with predictable, dose-related injuries characteristic for the particular drug. Other drugs cause damage only in "susceptible" persons. Such reactions are characterized as idiosyncratic. Through the years, the distinction between the two types of reactions has become less clear. Thus, in situations previously thought to be allergic reactions in susceptible patients, there now appears to be damage directly to cell membranes as a result of drug toxicity.
Different types of drugs can produce a cholestatic reaction. Cholestasis (obstructive jaundice) is a clinical and biochemical syndrome that occurs when bile flow is impaired. Some drug induced liver damage is virtually indistinguishable from chronic hepatitis and may even progress to cirrhosis. Chronic liver injury that histologically mimics alcoholic liver disease is also capable of being produced by certain drugs. NASH (Non-alcoholic Steroidal Hepatitis) is among such injuries.
Within eight months after Rezulin was sold in the United States, the Food and Drug Administration (FDA) stated that the drug had been linked to illness and death from liver failure. At that point the FDA recommended frequent monitoring of liver function in patients taking Rezulin. These problems had been seen while the drug was being tested according to Dr. Anne Peters, an endocrinologist at the University of California at Los Angeles. Dr. Peters noted that the abnormal test results were so extreme they should have been regarded as a "red flag." Dr. Peters, and others, believed that Rezulin should have been marketed from the beginning with strong warnings and the requirement that those taking the drug have frequent tests of liver function. Instead, the drug was marketed without any recommendation for liver monitoring.
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