Liver Transplantation

Heart Damage

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 and possible Rezulin side effects. 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.

Warner-Lambert knew of the dangerous Rezulin side effects far before the FDA ordered the diabetes drug to be withdrawn. If you have suffered Rezulin side effects because of the negligent practices that Warner-Lambert used to manufacture and market Rezulin, CONTACT A REZULIN SIDE EFFECTS LAWYER.

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 side effects 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 be a Rezulin side effect in many 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 side effects 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 side effects patients had suffered liver failure that resulted in mostly death or organ transplant. Liver damage, like other similar Rezulin side effects, 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

Warner-Lambert knew of the dangerous Rezulin side effects far before the FDA ordered the diabetes drug to be withdrawn. If you have suffered Rezulin side effects because of the negligent practices that Warner-Lambert used to manufacture and market the diabetes drug, CONTACT A REZULIN SIDE EFFECTS LAWYER.

top of page

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.

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.

Warner-Lambert knew of the dangerous Rezulin side effects far before the FDA ordered the diabetes drug to be withdrawn. If you have suffered Rezulin side effects because of the negligent practices that Warner-Lambert used to manufacture and market the diabetes drug, CONTACT A REZULIN SIDE EFFECTS LAWYER.

top of page

Heart Damage

Cardiac effects were the most consistent toxicity finding in studies in rats, mice, and dogs. Effects on the heart included increased size and weight, atrial thrombosis, and fluid accumulation around the lungs. Heart failure has been reported to the FDA as a Rezulin side effect at a much higher rate than for Glucotrol (glipizide), an older diabetes drug from the sulfonylurea class (56 cases of heart failure in the first 19 months of use for Rezulin vs. 4 cases after 13 years of Glucotrol use).

In 1996, an FDA diabetes specialist Dr. Robert Misbin was most concerned with Rezulin side effects because of “its potential for cardiac toxicity”. Undisclosed documents showing that concerns were raised about liver conditions also show that concerns were raised on Rezulin side effects on the heart. Guston Turner, a pharmacist from the FDA’s scientific investigations division, found inconsistencies in research measuring the Rezulin side effect on the heart. Turner felt the FDA, “should have delayed approval of Rezulin until all the questions were addressed.”
Click here to contact a Rezulin Side Effects Lawyer

In the mid 1990s, FDA pharmacologists were surprised by the findings of Rezulin side effects in animals when given doses of the diabetes drug. The animals ended up with discolored and overweight hearts that were Rezulin side effect related. Rats, dogs, and monkeys had developed heart problems from Rezulin, enough of an issue to cause a former FDA medical officer, Dr. John L. Gueriguian, to recommend Rezulin’s rejection in the 1990s after studying the diabetes drug. Gueriguian found that “in rats, in dogs, in monkeys- I’ve never seen a class of drug that had such a consistent pattern of cardiopulmonary toxicity,” (LA Times, 3-26-00).

While these findings in animals may not indicate Rezulin side effects would have the same effect in humans, the possibility of Rezulin side effects worsening a delicate preexisting vulnerability of heart failure could occur if Rezulin did cause abnormal fluid retention and weight gain. Since Rezulin was approved on the fast track a complete clinical trial to determine possible heart damage caused by Rezulin side effects 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. One hundred fourteen Rezulin side effects patients completed the study and no one was found to suffer a heart failure. But the FDA looked at the data and found that 26% of the Rezulin side effects patients involved in the study dropped out, leading them to believe there were irregularities in the data.
Click here to contact a Rezulin Side Effects Lawyer

In January 1997, the FDA had Turner, a veteran agency pharmacist, complete the review of Rezulin in the remaining three weeks in Buffalo and Omaha. Based off of Turner’s findings, the director of the FDA’s endocrine-drug division, Dr. Solomon Sobel, wrote in an email on January 13, 1997 that it was “disturbing” that variations existed in how different Warner-Lambert consultants had interpreted the same echocardiogram data recorded at Omaha. In Buffalo, Turner found that the echocardiograms had indicated an increase in left-ventricular-wall thickness. Both cases had ended with a senior FDA official making concessions in Warner-Lambert’s favor.

Turner later said of the Echo Study on Rezulin, “the real problem there was whether there was any heart enlargement or not. They ignored it,” (LA Times, 3-26-00). Even 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 the Rezulin side effects on patients who had preexisting heart disease evidence. Few patients were enrolled, and this study was never completed. Rezulin side effects patients did die of heart failure, but doctors claimed many of these patients had preexisting heart problems.

Warner-Lambert knew of the dangerous Rezulin side effects far before the FDA ordered the diabetes drug to be withdrawn. If you have suffered Rezulin side effects because of the negligent practices that Warner-Lambert used to manufacture and market the diabetes drug, CONTACT A REZULIN SIDE EFFECTS LAWYER.

top of page