The FDA, after reviewing safety data for troglitazone (Rezulin), recommended that the drug be removed from the market immediately. Rezulin has been associated with at least 61 patient deaths from hepatic failure. In a previous edition of Drug Therapy (Volume IX, Issue 4), we described the results of a scientific advisory committee hearing on the safety profile of Rezulin. At that time, the committee recommended increased monitoring of liver function during initiation of therapy. Based on the number of events since, it would appear the committee’s recommendations went unheeded.
Based on available evidence, Actos and Avandia appear to have a reduced incidence of hepatic dysfunction associated with their use. However, hepatic toxicity is still a possibility with the use of both. Here’s a synopsis of prescribing information for both for single drug therapy of Type II diabetes:
| Drug | Initial Dose | Maximum Dose | Monitoring |
| Actos (pioglitazone) | 15mg daily Price to Consumer* $80-90 for 30-day supply |
45mg daily Price to Consumer* $140-150 for 30-day supply |
Hepatic monitoring at baseline and every 2 months for the first year, periodically thereafter. |
| Avandia(rosiglitazone) | 4mg daily Price to Consumer* $70-80 for 30-day supply |
8mg daily Price to Consumer* $120-130 for 30-day supply |
Hepatic monitoring at baseline and every 2 months for the first year, periodically thereafter. |
*Prices based on survey of on-line pharmacy providers
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Clinicians are urged to follow FDA and manufacturer-recommended monitoring of patients initiated on Actos or Avandia therapy. Rapid identification of hepatic dysfunction and discontinuation of therapy are essential to limit patient injury. |