Rezulin Site Summary

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Rezulin Recall

Notable Quotes

“The Times, citing Warner-Lambert emails and memos, said the company knew as early as 1993 of at least one case of a patient who showed liver damage after taking Rezulin.”

MSNBC, March 11, 2001

“I am writing to enlist your aid in convincing my superiors at FDA that Rezulin should be removed from the market because of its unacceptably high risk of causing liver failure.”

Dr. Robert Misbin, FDA medical officer and Rezulin reviewer
(CNN, 3-22-00)

“Easily more people have died between the time of our petition and when this belated…(FDA)…action was taken.”

Sidney Wolfe, Public Citizen director of the time it took the FDA to withdraw Rezulin and the July 1998 petition. (CNN, 3-22-00)

“The Echo Study was not properly conducted, according to the standard protocol. I was not made aware of the fact that the patients from this site, in particular, for whatever reason, whether it was due to technique or whatever, that they had increased left ventricular mass.”

Dr. Paresh Dandona, endocrinologist who served as Warner-Lambert’s principal investigator for the Buffalo Echo Study (studying Rezulin’s relation to heart damage).
(LA Times, 3-26-00)


Rezulin Causes Possible Heart Damage

Since Rezulin was approved on the fast track a complete clinical trial to determine possible heart damage caused by Rezulin was not completed. Instead, the Echo Study was put together to determine whether the use of Rezulin for 48 weeks would result in a change in the left ventricle. The endocrinologist who served as Warner-Lambert’s principal investigator for the Echo study in Buffalo, Dr. Paresh Dandona, said “The Echo Study was not properly conducted, according to the standard protocol. I was not made aware of the fact that the patients from this site, in particular, for whatever reason, whether it was due to technique or whatever, that they had increased left ventricular mass,” (LA Times, 3-26-00).

After the FDA approval of Rezulin on January 29, 1997, officials had negotiated a nonbonding pledge from Warner-Lambert to start a new study to assess Rezulin’s effect on patients who had preexisting heart disease evidence. Few patients were enrolled, and this study was never completed. Rezulin patients did die of heart failure, but doctors claimed many of these patients had preexisting heart problems. Guston Turner, a pharmacist from the FDA’s scientific investigations division had found inconsistencies in research measuring Rezulin’s effect on the heart. Turner felt that the FDA “should have delayed approval of Rezulin until all the questions were addressed.”

click here to read the Effects of Rezulin . . .

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Key Rezulin Terms

:: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z ::

Alkaline Phosphatase
An enzyme produced by liver (and other) cells. Elevated blood levels of this substance may indicate abnormal function of the liver, found to occur in Rezulin patients.

Antibody
A Y-shaped protein on the surface of B cells that is secreted into the blood or lymph in response to an antigenic stimulus, such as a bacterium, virus, parasite, or transplanted organ, and that neutralizes the antigen by binding specifically to it; an immunoglobin.

Bile
A bitter, alkaline, brownish-yellow or greenish-yellow fluid that is secreted by the liver, stored in the gallbladder, and discharged into the duodenum and aids in the emulsification, digestion, and absorption of fats.

Biopsy
The removal and examination of tissue for diagnosis.

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Cirrhosis
A chronic disease of the liver characterized by the replacement of normal tissue with fibrous tissue and the loss of functional liver cells. Cirrhosis of the liver has caused Rezulin patients to need liver transplants and has led to numerous deaths.

Detoxify
To change a harmful substance into a safer form.

Diabetes
Diabetes is a disease in which patients have high levels of sugar in their blood. When Rezulin diabetes drug was first introduced to the market it was approved to help treat Type-2 diabetes, which affects more than 15 million Americans. This type of diabetes usually develops in adulthood and is caused by the body’s inability to make enough, or to effectively use, insulin.

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Enzyme
A protein made in the body and capable of changing a substance from one form to another.

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Glucose
A simple sugar that is the end product of carbohydrate digestion and is found in the blood.

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Hypoglycemia
An abnormally low level of glucose in the blood. Medication-induced is a common occurrence during the treatment of Type-2 diabetes. Rezulin was approved to treat Type-2 diabetes.

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Immunosuppressive Drug Treatment
Medications given to prevent rejection of a transplanted organ. After the numerous cases of liver damage Rezulin caused, the need for a liver transplant became necessary.

Insulin
A hormone secreted by the beta cells in the pancreas that controls the metabolism and cellular update of sugars, proteins and fats. As a drug it is used principally to control Type-2 diabetes.

Intravenous or IV
Refers to giving medicines or fluids directly through the veins.

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Jaundice
A yellowing of the skin and eyes caused by excess bile products in the blood. This would occur due to liver damage.

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Liver
A large, reddish-brown, glandular vertebrate organ located in the upper right portion of the abdominal cavity that secretes bile and is active in the formation of certain blood proteins and in the metabolism of carbohydrates, fats, and proteins. The liver is the largest solid organ in the body, situated on the right side below the diaphragm.

Liver Enzymes
Substances produced by the liver and released into the blood; these are measured to assess liver function.

Liver Transplantation
The Rezulin side effects that prompted the Rezulin recall include serious cases of liver damage and failure. Rezulin patients that have suffered liver damages sometimes require a liver transplant in which a diseased liver is replaced with a segment of liver from a healthy human donor (usually a relative or close friend).

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Rejection
The failure of a recipient's body to accept a transplanted tissue or organ as the result of immunological incompatability; immunological resistance to foreign tissue. The possibility for a liver transplant to be rejected after a Rezulin transplant surgery can occur.

Retransplantation
Due to organ rejection or transplant failure, some Rezulin patients will need another liver transplant and has to return to the waiting list.

Rezulin
Rezulin, or troglitazone, is a prescription medication created by Warner-Lambert to treat Type-2 diabetes. Rezulin has had serious health risks, including liver failure resulting in deaths, prompting the FDA diabetes drug recall of Rezulin on March 21, 2000.

Rezulin Lawsuit
Numerous Rezulin lawsuits have been settled due to the serious and life-threatening conditions Rezulin has caused. To learn if you may have a case for the Rezulin side effects you, or someone you love, has experienced, contact us.

Rezulin Lawyer
To contact an expert Rezulin lawyer contact us so that you can learn what damages you are entitled to for the Rezulin side effects you have experienced.

Rezulin Recall
Approximately two million diabetes patients took Rezulin prior to the FDA recall on March 21, 2000. The FDA had reports of 63 Rezulin liver failure deaths.

Rezulin Side Effects
The Rezulin side effects the diabetes drug has been directly linked to are serious, life-threatening conditions, including liver damage and liver failure resulting in death or the need for liver transplants. Rezulin side effects also include cirrhosis of the liver.

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Status
Indicates the degree of medical urgency for a Rezulin patient awaiting a liver transplant.

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Transplant Surgery
Is the transfer of a tissue or an organ from one person to another, or from one site to another in the same person. The liver damage Rezulin has caused from the use of the diabetes drug has led to Rezulin patients needing liver transplants.

Waiting List
Rezulin liver damages have resulted in the need for liver transplants. An evaluation by the transplant physician allows a Rezulin patient to be added to the national waiting list by the transplant center. Lists are specific to both geographic area and organ type, such as the liver. Each time a donor becomes available, the UNOS computer generates a list of potential recipients based on factors that include genetic similarity, organ size, medical urgency and time on the waiting list. Through this process, a new list is generated each time an organ becomes available.

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