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Rezulin Labeling Updated to Recommend More Frequent Patient Monitoring
JAMA. 1998;279:9.
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Updated labeling for troglitazone (Rezulin, Parke-Davis, Morris Plains, NJ) includes a new recommendation that liver enzyme levels should be measured in patients initially, then monthly for the first 6 months of treatment, every other month for the next 6 months, and periodically thereafter. The new labeling also makes the warning regarding potential liver toxicity more prominent and updates the effectiveness information to state that monotherapy should be discontinued if effective results are not achieved after a 6- to 8-week trial.
The labeling updates the changes made in November 1997 (JAMA. 1997;278:1728) that incorporated a new warning on idiosyncratic hepatocellular injury and a recommendation for liver function tests, but at a less intensive schedule than is now being recommended. At the time of the previous recommendation, the agency stated that it was aware of approximately 35 postmarketing reports of liver injury among US and Japanese patients taking the drug, . . . [Full Text of this Article]
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
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Troglitazone Treatment Increases Plasma Vascular Endothelial Growth Factor in Diabetic Patients and Its mRNA in 3T3-L1 Adipocytes
Emoto et al.
Diabetes 2001;50:1166-1170.
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