“Do not use Rezulin at all. It is too dangerous.”
-Sidney Wolfe, Public Citizen Health Research Group prior to the Rezulin recall, (USA Today, 3-7-00)

Launched in the U.S. in 1997, Rezulin was the first of thee thiazolidinediones or glitazones that help boost the effects of insulin and was seen as new hope for some diabetes patients. Approved in just six months on the FDA’s “fast track” Rezulin raised many serious concerns prior to its approval. The FDA required Rezulin’s label be changed four times up until the Rezulin recall on March 21, 2000. This FDA method has been widely criticized, especially since the doctors themselves do not even read the fine print warnings that drugs like Rezulin contained.

The controversial diabetes drug was shown to cause death and serious injuries to the liver and to the heart. Around two million people have used Rezulin and about 500,000 Americans were using Rezulin at the time of the recall. Public Citizen had been petitioning the FDA since July 1998 for the immediate ban of Rezulin because of liver problems.

On March 7, 2000, Public Citizen petitioned the FDA to immediately require class labeling for the diabetes drug Rezulin due to the inadequate, misleading, and potentially dangerous professional product labeling for Rezulin. Included in the Rezulin label change petition were safety concerns. Liver toxicity, effects on the heart, weight gain, edema, anemia, blood pressure lowering, plasma lipids, and hormone levels were all safety concerns Public Citizen had regarding the use of Rezulin. This petition was the last attempt Public Citizen made before the Rezulin recall on March 21, 2000.

Serious, life-threatening Rezulin side effects have been directly linked to the use of the diabetes drug. Warner-Lambert has been blamed in dozens of deaths from life failure and thousands of other liver damage cases from 1997-2000.

top

Liver Toxicity
In Great Britain, drug-induced instance of liver failure led to the Rezulin recall from the Great Britain market in December 1997, after the British government concluded that the risks of Rezulin therapy outweighed the potential benefits. The British government felt that “at present, no clear risk factors for the development of hepatic reactions have been identified which might allow the drug to be used safely in some patients.” Liver failures had been reported to the FDA in patients taking Rezulin, and as of March 1999, there were 43 reports of acute liver failure in the U.S., including 28 known deaths, leading Public Citizen to petition to ban Rezulin on July 27, 1998.

Liver damage that leads to liver failure and possibly death has been found to occur in Rezulin patients. Ninety cases of Rezulin failure that has been attributed to the diabetes drug have occurred. This number is assumed to be very conservative, including just 1-10% of the actual Rezulin fatalities due to underreporting according to experts. The ninety cases of Rezulin liver failure have resulted in 7 liver transplant survivors, 10 recoveries without a liver transplant, and 10 people continuing to suffer from liver failure.

The FDA’s top expert in assessing and preventing deaths related to the use of prescription drugs, Dr. David J. Graham, had concluded that Rezulin patients are 1,200 times more likely to suffer liver failure. Graham also added that at least 430 Rezulin patients had suffered liver failure that resulted in mostly death or organ transplant. Liver damage Rezulin can cause is especially dangerous because there are few specific indicators that a disease is present in the early stages in many cases. As the disease progresses, possible side effects may include:

• Coughing up or vomiting large amounts of blood
• Muscle wasting
• Jaundice
• Salivary gland enlargement
• Weakness
• Fatigue
• Weight loss
• Poor appetite
• Vomiting
• Abdominal pain
• Nausea
• Fever
• Dark urine
• Shrinking testicles or male breast enlargement
• Spider veins in the skin
• Hair loss
• Curling up of the fingers
• Redness of the palms
• Curling up of the fingers

Serious, life-threatening Rezulin side effects have been directly linked to the use of the diabetes drug. Warner-Lambert has been blamed in dozens of deaths from life failure and thousands of other liver damage cases from 1997-2000.

top

Liver Transplantation
A liver transplantation is a surgical replacement of the diseased liver with a healthy liver. Cirrhosis is one of the two main reasons a liver transplantation is necessary. An evaluation is completed and the patient is placed on the liver transplant waiting list with UNOS. The liver transplantation waiting time depends on the patient blood type, size, and general medical condition. Normally a liver is obtained from a person diagnosed as being brain dead but whose organs are still properly functioning. There is a continual shortage of liver donors due to the high incidence of liver disease, which has made the waiting time increase every year. Some people in need of a liver donor can get a portion of a family member or friend’s liver.

Liver transplantations take about 6-8 hours. Medication is immediately administered to keep the new liver from being rejected by the body. For most patients, their life can return to a normal and healthy life following a liver transplantation.

top

Liver Transplant Criteria
Liver patients who need transplants are ranked using sophisticated medical criteria instead of based on how long they’ve been on the waiting list under a system that was endorsed in 2000. This ensures the sickest patients receive a donor first. The scores used to determine which patients are in the most need of an immediate donor are based on a combination of the patient’s ability to form a blood clot, the ability to break down hemoglobin, and kidney function that can be affected by a failing liver that was developed by the Mayo Clinic. Because the number of patients waiting for a liver transplant continues to grow, there is a problem between supply and demand. In 1999, there were 4,698 liver transplants performed but 1,753 people died waiting. There are now more than 16,000 liver patients waiting to receive a healthy liver.

TransWeb is a nonprofit educational web site serving the world transplant community.

Serious, life-threatening Rezulin side effects have been directly linked to the use of the diabetes drug. Warner-Lambert has been blamed in dozens of deaths from life failure and thousands of other liver damage cases from 1997-2000.

top