Diabetes Drug Recall

The FDA approved Rezulin in January 1997. Warner-Lambert made $2.1 billion in Rezulin sales before the diabetes drug recall was issued in March 2000. Suspected of causing 391 deaths, including hundreds of liver damage cases, Rezulin manufacturer has found themselves in the middle of countless Rezulin lawsuits and investigations.




An FDA study found:

-An estimated 430 or more Rezulin patients have suffered liver failure.

-Rezulin 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 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 can attack the liver without warning.

About Diabetes

Type-Two Diabetes

Rezulin was created to treat type-two diabetes, which accounts for over 80% of diabetes cases. In type-two diabetes the body’s insulin production may be low, but the body’s cells resist insulin’s sugar-regulating effects. Most people with type-two diabetes do not have any signs or symptoms for many years, which can lead to unsuspected complications. When Rezulin was approved, it was the first of the thiazolidinediones or glitazones that help boost the effects of insulin and was seen as new hope for some diabetes patients. Drugs that are considered to be “breakthrough” status are sometimes able to speed through the FDA approval process, as Rezulin did. Normally taking years to become approved, Rezulin took just six months.

Type-Two Diabetes Symptoms

Type-two diabetes symptoms may go unrecognized for some time, including increased thirst, frequent urination, blurring of vision, abdominal discomfort, unusual fatigue, unexplained weight loss, tingling of the hands or feet, and poor healing of infections.
Early diagnosis and treatment of type 2 diabetes can help prevent serious problems that are hard to catch due to the gradual onset of the disease.

Type-Two Diabetes Treatment

People with type-two diabetes are usually recommended to combine a healthy diet and oral medication. Rezulin was supposed to help reduce the amount of insulin injections needed by some patients.

For those with type-2 diabetes, a combination of healthy diet and oral medications is standard, although insulin therapy may also be required; several new oral medications have recently become available.

Diabetes Resources

American Diabetes Association is a nonprofit health organization providing diabetes research, information and advocacy. The mission of the organization is to prevent and cure diabetes and to improve the lives of all people affected by diabetes.

http://www.diabetes.org/main/application/commercewf

Diabetes Public Health Resource is the official site of the Diabetes Division of the federal Centers for Disease Control and Prevention.

http://www.cdc.gov/diabetes/

National Institute of Diabetes & Digestive & Kidney Diseases.

http://www.niddk.nih.gov/health/diabetes/diabetes.htm

American Liver Foundation is the only national, voluntary non-profit health agency dedicated to preventing, treating and curing hepatitis and all liver diseases through research, education and support groups.

http://liverfoundation.org/

Liver Transplant Resource

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

http://transweb.org/

Rezulin Lawyer Resource

Rezulin Newsletter provides Rezulin diabetes drug recall information from expert Rezulin lawyers due to the number of serious side effects that have resulted from the direct use of the drug.


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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.

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