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Rezulin
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Rezulin (Troglitazone) is used to treat a certain type of diabetes mellitus (sugar diabetes) called type 2 diabetes. It may be used with
insulin, or with a type of oral diabetes medicine called a sulfonylurea, or with a sulfonylurea and metformin.
The FDA has asked the manufacturer of Rezulin to remove the product from the market. The drug's manufacturer, Parke-Davis / Warner-Lambert, has agreed to the FDA's request. The FDA took this action after its review of recent safety data on Rezulin and two similar drugs, rosiglitazone (Avandia) and
pioglitazone (Actos), showed that Rezulin is more toxic to the liver than the other two drugs. Data to date show that Avandia
and Actos, both approved in the past year, offer the same benefits as Rezulin without the same risk.
- California
Court Denies Class Certification to Rezulin Plaintiffs, Pfizer Inc., January
17, 2002
- Letter
from Parke-Davis to Pharmacists re: Withdrawal of Rezulin Tablets (PDF)
Mar 22, 2000
- Rezulin to be
Withdrawn from the Market From the Food and Drug Administration. Mar 21,
2000
- Press
Release: Warner-Lambert Voluntarily Discontinues the Sale of Rezulin (PDF)
Mar 21, 2000
- Presentation
of the Data and Rationale for Regulatory Action Regarding the Withdrawal from
the U.S. Market of Rezulin for the treatment of type 2 diabetes mellitus
(RTF) Transcript from Meeting No. 74 of the Endocrinologic and Metabolic Drugs
Advisory Committee. May 19, 2000
- Letter
from John B. Buse, MD, PhD, CDE, to U.S. Food and Drug Administration re:
Citizen's Petition to Require Class Labeling for Rezulin and Other Diabettes
Drugs Mar 15, 2000
- Rezulin
Drug Approval Documents Includes approval letter, medical reviews, clinical
pharmacology biopharmaceutics reviews, and administrative documents for the
use of Rezulin in combination with metformin and sulfornylurea in patients
with type 2 diabetes. Sep 16, 1999
- Letter from
Parke-Davis to Healthcare Professionals re: Modification to Rezulin Prescribing
Information Jun 17, 1999
- Rezulin Label
and Patient Information (PDF) Jun 17, 1999
- FDA Talk Paper:
New Labeling and Use Changes for Rezulin Significant new changes to the
labeling and recommended uses for Rezulin because of further evidence of serious
and sometimes fatal liver injury in patients treated with Rezulin. Jun 16,
1999
- Letter
from U.S. Food and Drug Administration to Sidney M. Wolfe, MD, Denying Public
Citizen's Health Research Group's Petition to Remove Rezulin from the Market
(PDF) May 26, 1999
- Discussion
of Experience Since Approval for Marketing of the Benefits and Risks of Troglitazone;
Discussion of Triple Therapy Involving Troglitazone with Sulfonylurea and
Metformin in the Treatment of Type 2 Diabetes Mellitus (1/5) (PDF) Transcript
from Meeting No. 72 of the Endocrinologic and Metabolic Drugs Advisory Committee.
Mar 26, 1999
- Discussion
of Benefits and Risks of Troglitazone (2/5) (PDF) Mar 26, 1999
- Discussion
of Benefits and Risks of Troglitazone (3/5) (PDF) Mar 26, 1999
- Discussion
of Benefits and Risks of Troglitazone (4/5) (PDF) Mar 26, 1999
- Discussion
of Benefits and Risks of Troglitazone (5/5) (PDF) Mar 26, 1999
- Letter
from Andrea Dunaif, MD, to the U.S. Food and Drug Administration Against Public
Citizen Health Research Group's Petition to Remove Rezulin from the Market
(PDF) Mar 23, 1999
- Letter
from Edward S. Horton, MD, to the U.S. Food and Drug Administration Against
Public Citizen Health Research Group's Petition to Remove Rezulin from the
Market (PDF) Mar 19, 1999
- Letter
from Robert R. Henry, MD, to U.S. Food and Drug Administration Against Public
Citizen Health Research Group's Petition to Remove Rezulin from the Market
(PDF) Mar 11, 1999
- Letter
from Lawrence D. Kelley, MD, to the U.S. Food and Drug Administration Against
Withdrawal of Rezulin (PDF) Mar 8, 1999
- Letter
from Leann Olansky, MD, to U.S. Food and Drug Administration Against Public
Citizen Health Research Group's Petition to Withdraw Rezulin from the Market
(PDF) Mar 1, 1999
- Letter
from Kathleen A. Alm, M.D. to U.S. Food and Drug Administration in Support
of Rezulin (PDF) Feb 22, 1999
- Letter from
Parke-Davis to Healthcare Professionals re: Monitoring Liver Function and
Modifications to Monotherapy Prescribing Information Jul 28, 1998
- Letter from
Parke-Davis to Healthcare Professionals re: Monitoring Patient Liver Enzymes
and Bilirubin Levels Dec 1, 1997
- FDA Talk Paper:
Patient Testing and Labeling Strengthened for Rezulin Dec 1, 1997
- FDA Talk Paper:
Rezulin Labeling Changes Manufacturer changing prescribing information
and adding new warning information to the labeling bcause of reports of liver
injury associated with the use of Rezulin. Nov 3, 1997
- Letter from
Parke-Davis to Healthcare Professionals re: Change in Prescribing Information
Lists new warnings, precautions and adverse reactions because of liver injuries
arising from the use of Rezulin. Oct 28, 1997
- Rezulin
Drug Approval Documents Includes approval letter, medical reviews, and
administrative documents for the use of Rezulin in combination with sulfonylureas
in the treatment of type II diabetes, as a monotherapy in type II diabetes,
and in a 300 mg tablet dosage form. Aug 4, 1997
- Letter from U.S.
Food and Drug Administration to Parke-Davis re: False and Misleading Promotional
Materials for Rezulin Tablets Feb 24, 1997
- FDA Talk Paper:
FDA Approves Rezulin for Diabetes Patients Poorly Controlled on Insulin Therapy
Jan 30, 1997
- Troglitazone
for Diabetes Mellitus (1/4) (PDF) Transcript of Meeting No. 65 of the
Endocrinologic and Metabolic Drugs Advisory Committee. Dec 11, 1996
- Troglitazone
for Diabetes Mellitus (2/4) (PDF) Dec 11, 1996
- Troglitazone
for Diabetes Mellitus (3/4) (PDF) Dec 11, 1996
- Troglitazone
for Diabetes Mellitus (4/4) (PDF) Dec 11, 1996
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