Rezulin Risk Factors

There are more than 15 million Americans with Type-2 diabetes and of them, approximately one million have taken Rezulin since it first became publicly available.

The effects of Rezulin range from mild changes in liver tests to complete liver failure due to liver toxicity. The Food and Drug Administration's studies discovered at least 38 known cases of acute liver failure among Rezulin patients. Several patients suffering from liver toxicity in the reported cases underwent liver transplant procedures, five survived without a transplant, and 28 of these Rezulin patients died.

Both the FDA and Warner Lambert issued warnings that patients using Rezulin should be regularly tested (approximately once a month) to determine liver health. Yet several patients who took the recommended precautions still died of severe liver toxicity that appeared just weeks after they had successfully passed a liver test.

Rezulin News Timeline

1997
January - Rezulin is approved by the FDA to treat Type II diabetes.
November - The FDA issues a warning about Rezulin (troglitazone). Recommended prescribing information is changed by the drug's manufacturer; new warning label information is added.
December - Approximately 150 adverse events associated with Rezulin have been reported to the FDA.
1998
June - The FDA and Rezulin manufacturer Parke-Davis agree to again tighten restrictions on the use of Rezulin.
July - Parke-Davis sends a letter to heathcare professionals warning to test for liver abnormalities and updating them on the changes in recommended use.
2001
March - Resulin sales are discontinued.

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Last Updated: May 11, 2010. 11:08:31 am.