Rezulin Side Effects

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 Side Effects Cause Possible Heart Damage

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 Rezulin side effects would cause a change in the left ventricle if taken for 48 weeks. 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 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. Guston Turner, a pharmacist from the FDA’s scientific investigations division had found inconsistencies in research measuring Rezulin side effects on the heart. Turner felt that the FDA “should have delayed approval of Rezulin until all the questions were addressed.”

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Rezulin Side Effects

Rezulin Liver Damage Symptoms

Cirrhosis of the Liver

Liver Transplantation

Heart Damage

Rezulin side effects have been directly linked to life threatening conditions of liver damage. By the time Rezulin was recalled there were reports of 90 cases of liver failure, ending in the deaths of 63 people. This number is probably low due to the underreporting that occurs, which is 1-10% of actual fatalities according to experts. The liver is the largest organ in the body that is essential to keep the body properly functioning. The liver removes or neutralizes poisons from the blood, makes proteins to regulate blood clotting, and produces bile to help absorb fats and fat-soluble vitamins. Without a functioning liver a person cannot live.

The evidence that Rezulin side effects causes liver damage was confirmed when on March 21, 2000, the FDA announced they were taking Rezulin off the market after Rezulin side effects caused 63 deaths. There are no symptoms of Rezulin liver damage in the early stages, making it difficult to detect, as well as causing Rezulin side effects to be even more dangerous. If you have suffered any dangerous Rezulin side effects, CONTACT US to speak with an expert Rezulin side effects lawyer.

Rezulin Liver Damage Symptoms

The ingestion of prescription drugs is a public health problem because of the drug-induced liver toxicity that they can cause. Liver damage leading to liver failure and the possibility of death continues to increase because of the products that contain chemicals that are processed and detoxify by the liver. The chemical processes can produce symptoms that injure liver cells in people that lead to instances of the Rezulin side effects of liver damage. Symptoms of liver damage can vary depending on what type of liver disease has resulted. When a Rezulin side effects patient gets cirrhosis of the liver the symptoms are not always apparent. The liver damage Rezulin side effects cause lead to instances of liver transplantation and death. Some of the more common Rezulin side effects of liver damage include:

• weakness
• fatigue
• poor appetite
• weight loss
• vomiting
• jaundice
• nausea
• fever
• abdominal pain
• dark urine
• shrinking testicles or male breast enlargement
• muscle wasting
• spider veins in the skin
• hair loss
• curling up of the fingers
• salivary gland enlargement
• redness of the palms
• coughing up or vomiting large amounts of blood

If you have experienced any of these Rezulin side effects, you are advised to get a liver function test and see your doctor. Please CONTACT US to speak directly with an expert Rezulin side effects lawyer.

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Cirrhosis of the Liver

Cirrhosis of the liver can occur when scar tissue replaces normal tissue in the liver, as the liver cells are injured. Rezulin side effects include this liver disease that causes blood flow through the liver to have problems. In many instances there are few specific indicators that the disease is even present during the early stages. As the scar tissue continues to replace healthy cells, liver functioning starts to fail and a person suffering these Rezulin side effects may experience:

• Fatigue
• Nausea
• Exhaustion
• Loss of appetite
• Weakness
• Weight loss

Cirrhosis of the liver continues to progress and sometimes other complications develop as well. This may include:

• Itching due to bile products deposited into the skin.
• Edema and ascites when the liver loses its ability to make the protein albumin.
• Jaundice when the diseased liver cannot absorb enough bilirubin.
• Bruising and bleeding may occur when the liver start stopping production of the proteins needed for blood clotting.
• Gallstones can develop if the cirrhosis prevents bile from reaching the gallbladder.
• Portal hypertension occurs if the cirrhosis slows the normal flow of blood through the portal vein and increases the pressure inside it.
• Toxins in the blood or brain can occur because a damaged liver cannot remove toxins from the blood and it leads to accumulation in the blood and then brain. Toxins can severely affect a person by dulling mental functioning, causing personality changes, coma, and death.
• Sensitivity to medication happens because cirrhosis slows the liver’s ability to filter medications from the blood. The liver doesn’t remove drugs from the blood at the usual rate so it acts longer and builds up within the body.
• Varices occur when the blood flow through the portal vein slows and blood from the intestines and spleen backs up into blood vessels in the stomach and esophagus. The blood vessels can become enlarged because they are not meant to carry that amount of blood and can burst.

Problems in other organs can occur because cirrhosis can cause immune system dysfunction that leads to infection.

If you have experienced any of these Rezulin side effects, you are advised to get a liver function test and see your doctor. Please CONTACT US to speak directly with an expert Rezulin side effects lawyer.

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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.

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.

If you have experienced any of these Rezulin side effects, you are advised to get a liver function test and see your doctor. Please CONTACT US to speak directly with an expert Rezulin side effects lawyer.

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Possible Rezulin Heart Damage

Rezulin side effects may cause heart problems or exacerbate a pre-existing heart condition. In 1996, an FDA diabetes specialist Dr. Robert Misbin was most concerned with “its potential for cardiac toxicity”. Undisclosed documents showing that concerns were raised about liver conditions also show that concerns were raised about the Rezulin side effects on the heart. An L.A. Times article from March 26, 2000 included Guston Turner, a pharmacist from the FDA’s scientific investigations division, who had found inconsistencies in research measuring Rezulin side effects on the heart. Turner felt that the FDA, “should have delayed approval of Rezulin until all the questions were addressed.”

In the mid 1990s, FDA pharmacologists were surprised by the Rezulin side effects in animals given doses of the diabetes drug. The Rezulin side effects in the animals included discolored and overweight hearts. Rats, dogs, and monkeys had developed heart problems from Rezulin side effects, 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 be the same in humans, the possibility of Rezulin worsening a delicate preexisting vulnerability to 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.

In January 1997, the FDA had Turner, a veteran agency pharmacist, complete the review of Rezulin side effects 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 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.

If you have experienced any of these Rezulin side effects, you are advised to get a liver function test and see your doctor. Please CONTACT US to speak directly with an expert Rezulin side effects lawyer.