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Troglitazone Side Effects

Applies to troglitazone: oral tablet

Hepatic

During clinical trials, 1.9% of patients experienced reversible elevations in alanine transaminase (ALT) greater than 3 times the upper normal limit. Approximately 5% of patients had ALT levels greater than 1.5 times the upper limit of normal. Hyperbilirubinemia was found in 0.7% of patients (however, this incidence was less than that of patients receiving placebo).[Ref]

Hepatic side effects including severe idiosyncratic hepatocellular injury have been reported. Troglitazone has been removed from the market by its manufacturer after the FDA found that the risk of severe liver toxicity associated with the use of troglitazone was unacceptably high compared with the relatively low risk of hepatotoxicity associated with the use of two similar and safer alternatives, rosiglitazone and pioglitazone.

Hepatotoxicity associated with the use of troglitazone has usually been reversible. Hepatic failure leading to liver transplant or death has very rarely been reported.

It is recommended that clinicians choose alternative therapy and that patients who are taking troglitazone discontinue troglitazone therapy after consulting with their prescribing health care provider.[Ref]

General

Troglitazone is generally well tolerated with the incidence of adverse effects similar to placebo. Headache, asthenia, dizziness, back pain and nausea are reported slightly more frequently than placebo in clinical trials.[Ref]

Endocrine

Endocrine side effects including hypoglycemia may occur when troglitazone is used in combination with other hypoglycemic agents such as insulin or sulfonylureas. However, it has not been reported with troglitazone monotherapy.[Ref]

Hematologic

Hematologic effects include small decreases in hemoglobin, hematocrit, and neutrophil counts. These effects typically occur in the first four to eight weeks of therapy and may be related to an increase in plasma volume.[Ref]

Metabolic

Metabolic side effects including small changes in lipid levels may occur in patients receiving troglitazone.[Ref]

References

1. NeuschwanderTetri BA, Isley WL, Oki JC, Ramrakhiani S, Quiason SG, Phillips NJ, Brunt EM "Troglitazone-induced hepatic failure leading to liver transplantation - A case report." Ann Intern Med 129 (1998): 38-41

2. Neuschwander-Tetre BA, Isley WL, Oki JC, et al. "Troglitazone-induced hepatic failure leading to liver transplantation: a case report." Ann Intern Med 129 (1998): 38-41

3. Gitlin N, Julie NL, Spurr CL, Lim KN, Juarbe HM "Two cases of severe clinical and histologic hepatotoxicity associated with troglitazone." Ann Intern Med 129 (1998): 36-8

4. Watkins PB, Whitcomb RW "Hepatic dysfunction associated with troglitazone." N Engl J Med 338 (1998): 916-7

5. "Product Information. Rezulin (troglitazone)." Parke-Davis, Morris Plains, NJ.

6. Matsumoto K, Miyake S, Yano M, Ueki Y, Tominaga Y "Increase of lipoprotein (a) with troglitazone." Lancet 350 (1997): 1748-9

It is possible that some side effects of troglitazone may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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