Rezulin^® (also known as Noscal and troglitazone) was manufactured by the Warner Lambert Company (which was later purchased by Pfizer Inc.).  It was developed to treat Type 2 or adult-onset diabetes and was approved for that use in early 1997.  Rezulin works by lowering blood sugar levels by helping the body better respond to insulin (it was not a replacement therapy for insulin).  Insulin, assisted by Rezulin, removes sugar from the blood and helps transport it to the cells for energy production.  Improperly treated, diabetes can result in heart and kidney failure and blindness.

The FDA approved Rezulin^® on a 'fast track' basis despite links to several liver-related deaths.  To obtain this expedited approval, it has been alleged that Warner Lambert misled the FDA by inaccurately reporting the risks of Rezulin^®.  If this is true, and the manufacturer intentionally misrepresented the benign nature of the drug's risks, there would be a violation of federal law which prohibits the deliberate concealing of important facts related to a drug's safety.  There is also concern that Warner Lambert hid facts related to a Rezulin-related death

The greatest concern with Rezulin^® use is liver damage and failure.  There are few visible symptoms of early stage liver damage/disease and there is no pain associated with the disease at early stages.  At more advanced stages, yellowing of the skin and eyes will occur.  Nausea will also ensue.  Ultimately, the liver may fail to function properly, if at all.  When the liver ceases to function, the result is death unless there is a successful liver transplant.

Early in its use, the FDA required the manufacturer to replace warning labels so that consumers could be made aware of discovered harmful impacts.  The most important label change was related to the potential for liver damage.  An FDA Advisory Committee also recommended (not required) that Rezulin^® use be prohibited for persons whose diabetes could be properly regulated with insulin or less harmful drugs.  Eventually, the FDA sought to remove Rezulin from the market, however, for a little more than two years Warner Lambert prevented the withdrawal.  Rezulin was ultimately withdrawn from the United States market on March 21, 2000.  Specifically, the recall cited unacceptable risk of use to diabetes patients from liver damage or failure.  Before the drug was recalled, Warner Lambert had generated approximately $2.0 billion in revenue but at the cost of more than 375 Rezulin-related deaths.

Troglitazone, the active ingredient in Rezulin^®, has not been widely studied in pregnant women.  It is not known therefore, whether infants were exposed to the drug during breast-feeding.  Studies have been conducted only in adult patients, including some elderly subjects.  Thus, there is no specific data regarding harm to fetuses, infants, or children from Rezulin use.

Rezulin^® use may cause or exacerbate many health-related conditions and/or symptoms:

If you need assistance with a Rezulin^®-related injury please contact us.

NAME	DESCRIPTION
Warner Lambert Company	The manufacturer of Rezulin®.  Warner Lambert was purchased by Pfizer Inc. to become the second largest pharmaceutical in the world.
Food and Drug Administration	The U.S. Food and Drug Administration. (FDA)
Why Drugs Get Pulled of the Market?	FDA article on why drugs are withdrawn from the market.
Rezulin Information from the FDA	Searchable database from the FDA Center for Drug Evaluation and Research (CDER).
Rezulin tablets / Troglitazone	New Drug Application for Rezulin.   pdf document
Rezulin Withdrawn from the Market in 2000	FDA notice on the removal of Rezulin from the market - March 21, 2000.
FDA Changes to Rezulin Use in 1999	FDA New Labeling and Use Changes for Rezulin - June 16, 1999.
Document sent to FDA to Oppose Rezulin Withdrawal	Opposition to the Withdrawal of Rezulin - Received by FDA on March 19, 1999.   pdf document
Patient Testing and Labeling Strengthened for Rezulin - 1997	FDA Talk Papers - Rezulin regulation becomes more restrictive - December 1, 1997.
FDA Rezulin Warning from 1997	FDA Warning about Rezulin - February 24, 1997.   pdf document
Information on Rezulin from the Drug Advisory Committee	FDA Endocrinologic and Metabolic Drugs Advisory Committee on Rezulin.
Medline from the National Institutes of Health (NIH)	Medline is provided by the National Institutes of Health, National Library of Medicine
Information on Rezulin from Medline(Locate on List as Troglitazone)	Information from Medline about Rezulin.
Rezulin -     Troglitazone (Systemic) USP DI	Information from Medline about Troglitazone.
InteliHealth -     Rezulin Information     Troglitazone Information	Searchable directory from InteliHealth, an Aetna Company.
Rezulin - Rhabdomyolysis Associated With Troglitazone	Report on Rezulin user who experienced muscle atrophy.
American Family Physician - Removal of Rezulin	Explains the removal of Rezulin from the US market - discusses liver toxicity.
WebMD Reports of more Rezulin Deaths	1999 WebMD article reviews the rising death toll associated with Rezulin use.