The Troglitazone story

• Warner Lambert / Parke Davis / Pfizer (U.S.)
• GlaxoWellcome (GlaxoSmithKline etc.) (U.K.)

Warner-Lambert / Parke-Davis / Pfizer

• Research protocols
• Dear Doctor letters
• Rezulin package inserts
• Press releases
• Annual report
• Correspondence

Research protocols

Balagtas C, Loi CM, Radke-Mitchell L, Randinitis E, Valiquett T. (1995)
A 12-week double blind, placebo-controlled, multicenter, dose-response study of troglitazone (CI-991) in patients with noninsulin-dependent diabetes mellitus (NIDDM).
Protocol 991-031. RR 720-03368, 1-88. 23 March.
Parke-Davis Pharmaceutical Research Division of Warner-Lambert Company.

Faja BW, Ghazzi M, Huang S, Loi CM, Randinitis E. (1996)
An open-label, positive-controlled, 48-week, multicenter study of troglitazone (CI-991) in patients with noninsulin-dependent diabetes mellitus to assess potential effects on cardiac mass and function.
Protocol 991-042. RR 720-03523, 1-77. 24 June.
Parke-Davis Pharmaceutical Research Division of Warner-Lambert Company.

Faja BW, Mathias N, Nelson D. (1996)
A double-blind, placebo-controlled, 26-week, multicenter study of troglitazone (CI-991) in patients with noninsulin-dependent diabetes mellitus (NIDDM) requiring insulin.
Protocol 991-068. RR 72003628, 1-65. 22 July.
Parke-Davis Pharmaceutical Research Division of Warner-Lambert Company.

Baron B, Valiquett T, Venable T. (1996)
A randomized, double-blind, placebo-controlled multicenter study of the effect of CI-991 on glycemic control in insulin-treated noninsulin-dependent diabetes mellitus patients.
Protocol 991-040. RR 720-03729, 1-70. 23 July.
Parke-Davis Pharmaceutical Research Division of Warner-Lambert Company.

Radke-Mitchell L, Valiquett T, Huang S. (1997)
A 6-month, double blind, placebo-controlled, multicenter study of troglitazone (CI-991) in patients with noninsulin-dependent diabetes mellitus (NIDDM).
Protocol 991-032. RR 720-03608, 1-67. 14 January.
Parke-Davis Pharmaceutical Research Division of Warner-Lambert Company.

Baron B, Mathias N, Nelson D. (1997)
A 20-week, double blind, randomized study of troglitazone (CI-991) in patients with noninsulin-dependent diabetes mellitus.
Protocol 991-057. RR 720-03774, 1-39.
Parke-Davis Pharmaceutical Research Division of Warner-Lambert Company.

Ghazzi M, Radke-Mitchell L, Venable T, Loi CM. (1997)
A 12-month, double blind, randomized, active-control, multicenter study of troglitazone/glyburide combination in patients with noninsulin-dependent diabetes mellitus (NIDDM) who are sulphonylurea failures.
Protocol 991-055. RR 720-03526. 20 January.
Parke-Davis Pharmaceutical Research Division of Warner-Lambert.

Radke-Mitchell L, Foyt H. (1997)
A study to compare the efficacy, safety and tolerability of oral GR92132X with oral glibenclamide in the treatment of noninsulin dependent diabetes mellitus for a period of 12 month (interim report [6-month data].
Glaxo Protocol THZB3009. RR 720-03879, 1-28. 21 May.
Parke-Davis Pharmaceutical Research Division of Warner-Lambert Company.

Schneider P, Harris A, Maggs D. (2000)
A multicenter, 24-week, double blind, randomized, placebo-controlled, parallel-group study to reduce insulin injection frequency to once daily (QD) with the addition of troglitazone (CI-991) in type 2 diabetes mellitus patients.
Protocol 991-111. RR 995-00100, 1-64. 18 May.
Parke-Davis Medical Research Department of Warner-Lambert Company.

Radke-Mitchell L, Foyt H. (1997)
A double blind parallel-group study to compare the efficacy, safety and tolerability of oral GR92132X (100, 200, and 600 mg) with oral metformin (titrated to response up to 3000 mg) in the treatment of patients with noninsulin dependent diabetes mellitus.
Glaxo Protocol THZB3002. RR 720-03878, 1-34. 3 June.
Parke-Davis Pharmaceutical Research Division of Warner-Lambert Company.

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Dear Doctor letters

Important drug warning. Morris Plains, NJ: Parke-Davis, 28 October 1997

Dear Healthcare Professional. Morris Plains, NJ: Parke-Davis, 1 December 1997

Important drug warning. Morris Plains, NJ: Parke-Davis, 28 July 1998

Important prescribing information. Morris Plains, NJ, 17 June 1999

Important drug warning; product withdrawal. Morris Plains, NJ: Warner-Lambert Company, Medical & Scientific Affairs, 22 March 2000.

Important drug warning. Morris Plains, NJ: Warner-Lambert Company, Medical & Scientific Affairs, 22 March 2000.

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Rezulin package inserts

Rezulin (troglitazone) tablets. Morris Plains, NJ: Parke-Davis, February 1999.

Parke-Davis Pharmaceuticals Ltd. Rezulin ® (Troglitazone) tablets. Morris Plains, NJ, June 1999. 15pp.

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Press releases

Warner-Lambert pleased by FDA Advisory Committee recommendation on rezulin. Washington, D.C.: Warner-Lambert, 26 March 1999.

Rezulin: fiction vs fact. Washington, D.C.: Warner-Lambert, 26 March 1999.

New facts about rezulin. Washington, D.C.: Warner-Lambert, 26 March 1999.

Risk-benefit assessment of rezulin. Washington, D.C.: Warner-Lambert, 26 March 1999.

The postmarketing surveillance system. Washington, D.C.: Warner-Lambert, 26 March 1999.

The incidence of liver effects in rezulin clinical trials and postmarketing surveillance. Washington, D.C.: Warner-Lambert, 26 March 1999.

Warner-Lambert responds to recent media reports relating to REZULIN, its therapy for type 2 diabetes. Morris Plains, NJ: Warner-Lambert, 24 February 2000.

Warner-Lambert voluntarily withdraws REZULIN. Morris Plains, NJ: Warner-Lambert, 21 March 2000.

Texas verdict finds Warner-Lambert not liable in Rezulin trial. New York: Pfizer, 19 February 2003.

California court of appeal affirms denial of class certification to Rezulin plaintiffs. New York: Pfizer, 31 March 2003.

Pfizer will seek to set aside a New York Rezulin verdict. New York: Pfizer, 3 April 2003.

West Virginia Supreme Court of Appeals reverses order denying class certification to Rezulin plaintiffs. New York: Pfizer, 4 July 2003.

California verdict finds Warner-Lambert not liable in Rezulin trial. New York: Pfizer, 27 May 2004

Pfizer reaches agreement to settle Rezulin lawsuit in Illinois. New York: Pfizer, 2 July 2004.

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Annual report

Pfizer Annual Report 2001 (Section on Products Liability Matters)

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Correspondence

Taylor, Mary E (Senior Director, Worldwide Regulatory Affairs, Warner-Lambert/Parke-Davis Research and Development). Correspondence to John Jenkins (Acting Director, Division of Metabolic & Endocrine Drug Products, Food and Drug Administration) regarding Parke-Davis handling of data generated at the study site (Parke-Davis study 991-042) of Dr Janet McGill, 14 March 2000.

King, KF (Senior Vice President Worldwide Regulatory Affairs, Warner-Lambert/Parke-Davis). Correspondence Dr Lumpkin, Center for Drug Evaluation and Research, FDA, 20 March 2000.

King, KF (Senior Vice President Worldwide Regulatory Affairs, Warner-Lambert/Parke-Davis). Correspondence to Jane Henney, FDA, 20 March 2000 re allegations made by the Public Citizen’s Health Research Group to the FDA on 14 March 2000.

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GlaxoWellcome (GlaxoSmithKline etc)

Dear Doctor Letter. Important new safety information. Greenford, Middlesex: GlaxoWellcome, 31 October 1997.

Dear Doctor Letter. Suspension of availability of troglitazone (Romozin).Greenford, Middlesex: Glaxo Wellcome, 29 November 1997.

Dear Doctor letter. Troglitazone (Romoxin TM) Important new safety information. Greenford, Middlesex: Glaxo Wellcome, 29 November 1997.

Troglitazone not approved for re-introduction in the UK. London: GlaxoSmithKline, 22 March 1999.

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