Rezulin Side Effects

Public Citizen consumer group had been pushing for the Rezulin recall years before the FDA issued the recall. The advocacy group was concerned with the Rezulin side effects that had raised safety concerns even before the diabetes drug was ever approved. Some of these Rezulin side effects that raised concern included, liver toxicity, effects on the heart, weight gain, edema, anemia, blood pressure lowering, plasma lipids, and hormone levels. Warner-Lambert knew of the dangerous Rezulin side effects far before the FDA ordered the diabetes drug to be withdrawn.

If you have taken Rezulin and would like more information regarding the Rezulin side effects and the recall of this drug, contact us to speak with a Rezulin side effects attorney. You may be entitled to a large compensation for the damages and suffering that have resulted from taking the diabetes drug. Some Rezulin side effects include:

Liver Toxicity

Liver Transplantation

Heart Damage

Liver Toxicity
Great Britain was the first country to issue a Rezulin recall. This action came in December 1997, after repeated reports of liver failure was directly linked to being one of the Rezulin side effects. The British government had concluded that the risks of Rezulin outweighed the potential benefits. In addition, the government felt that there were no instances that Rezulin could be safely administered in any patients due to the high risk of potential liver damage. The U.S.'s FDA continued to allow the drug to be sold on the U.S. market, despite deadly Rezulin side effects, and by March 1999, there had been 43 reports of acute liver failure, including 28 reported deaths. Public Citizen had already petitioned the FDA for the immediate removal of Rezulin from the market on July 27, 1998, but the FDA had not taken action.

Rezulin side effects patients were experiencing liver damage leading to liver failure and possibly death. Liver damage is dangerous for what can result from it and how hard it can be to catch it early due to the few specific symptoms. In the ninety cases of Rezulin liver failure, there were 7 liver transplant survivors, 10 recoveries without a liver transplant, and 10 people continuing to suffer from liver failure. It has been found that Rezulin patients are 1,200 times more likely to suffer a liver failure, and at least 430 Rezulin side effects patients had suffered liver failure that largely resulted in either death or organ transplant.

As liver failure progresses, side effects can include any of the following:

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

Warner-Lambert tried to downplay the known Rezulin side effects by claiming their diabetes drug was low risk upon FDA approval. If you would like more information on the Rezulin recall, contact a Rezulin Attorney concerning possible Rezulin side effects.

top

Liver Transplantation
Due to Rezulin side effects of liver damage that resulted, liver transplantations became necessary. A liver transplantation is a surgical replacement of the diseased liver with a healthy liver. If a liver transplant is necessary, an evaluation is completed and the Rezulin side effects patient is placed on the liver transplant waiting list with UNOS. The waiting time depends on the Rezulin patient's blood type, size, and general medical condition.

Livers are normally obtained from a person diagnosed as being brain dead but whose organs are still properly functioning. When a Rezulin side effects patient needs a liver transplant it is very hard due to the continual shortage of liver donors due that have resulted from a high incidence of liver disease. Every year the waiting time for a liver has increased as a result of this. Rezulin patients who are unable to get a portion of a family member or friend's liver will have to wait. 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 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.

The actually surgical procedure for a liver transplantation takes about 6-8 hours. Following the procedure, medication is immediately administered to keep the new liver from being rejected by the body. Most Rezulin liver transplant patients will be able to return to a normal life.

If you would like more information on Rezulin side effects and the recall of the diabetes drug, contact us to speak with a Rezulin attorney.

top

Heart Damage
Cardiac effects as a result of taking Rezulin were the most consistent toxicity finding in studies in rats, mice, and dogs. Rezulin side effects of the heart included increased size and weight, atrial thrombosis, and fluid accumulation around the lungs. Although Rezulin was FDA approved on the "fast track" because of its "breakthrough" status, the heart failure reported to the FDA for Rezulin was 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, FDA diabetes specialist Dr. Robert Misbin voiced that his largest concern was Rezulin's "potential for cardiac toxicity". Later, undisclosed documents were found showing concerns were raised not only about Rezulin liver conditions, but that concerns were raised for Rezulin's potential to affect on the heart. A pharmacist from the FDA's scientific investigations division, Guston Turner, felt the FDA, "should have delayed approval of Rezulin until all the questions were addressed" due to the inconsistencies in research measuring Rezulin's effect on the heart (LA Times, 3-26-00).

Animals given doses of the diabetes drug in the mid 1990s surprised FDA pharmacologists when the animals ended up with Rezulin side effects including discolored and overweight hearts. 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).

These Rezulin animal studies may not indicate Rezulin side effects would be the same in humans, but the possibility of Rezulin worsening a delicate preexisting vulnerability to heart failure could. Rezulin's "fast track" status did not allow complete clinical trials to be completed to determine the risk of Rezulin side effects causing heart damage. The Echo Study instead replaced complete clinical trials, 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 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 taken Rezulin and would like more information regarding Rezulin side effects and the drug recall, contact us to speak with a Rezulin attorney. You may be entitled to a large compensation for the damages and suffering that have resulted from Rezulin side effects.

top