Rezulin Side Effects News

>Liver Toxicity
>Liver Transplantation

• An estimated 430 or more Rezulin side effects patients have suffered liver failure.
• Rezulin side effects patients have an increased risk of 1,200 times of having a liver failure due to the diabetes drug use.
• One out of every 1,800 Rezulin side effects patients could suffer a liver failure, and at the time of the Rezulin recall there had been an estimated 2 million Rezulin patients.
• Despite the FDA’s instructions and numerous Rezulin label updates for regular liver monitoring, getting liver tests does not guarantee a patient’s safety because Rezulin side effects can attack the liver without warning.

Approved on the FDA’s “fast track” in just six months, Rezulin raised many serious concerns prior to its approval. The FDA required strengthening Rezulin’s label four times 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 Rezulin side effects 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 the drug because of Rezulin side effects, including liver problems that began surfacing immediately upon its arrival. In the first six weeks there were 20 Rezulin side effects related deaths.

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 like, liver toxicity, effects on the heart, weight gain, edema, anemia, blood pressure lowering, plasma lipids, and hormone levels regarding the use of Rezulin. This petition was the last attempt Public Citizen made before the Rezulin recall on March 21, 2000.

Life-threatening Rezulin side effects have been directly linked to the use of the diabetes drug. Warner-Lambert has been blamed in dozens of Rezulin side effects deaths from liver failure and thousands of other liver damage cases from 1997-2000 due to negligent manufacturing and marketing as well as withholding important information regarding the safety of the drug. Contact us to speak directly with an expert Rezulin side effects lawyer.

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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.” Rezulin continued to be sold and marketed in the U.S. despite Great Britain’s recall, leading Public Citizen to petition to ban for the immediate removal of Rezulin on July 27, 1998.

Liver damage that leads to liver failure and possibly death has been found to occur in Rezulin side effects 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 patients had suffered liver failure that resulted in mostly death or organ transplant. Liver damage that Rezulin side effects 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

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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.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.

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

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

http://transweb.org/

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A 1998 Public Citizen survey found the FDA could require manufacturers to conduct phase IV studies as a condition of approval. According to the reports, at least one phase IV study was required for 195 of 306 new drugs approved by the FDA during the 1990s, but just 11 of the 195 Phase IV studies had been completed. This pertains to the safety of Rezulin because a complete clinical trial was not completed prior to the FDA approval of the diabetes drug due to the "fast track" method used on the drug. After Rezulin was approved, official 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.