BlackBoxRX
 
We highly recommend enabling Javascript while using the BlackBoxRX site.

Pioglitazone, Rosiglitazone

Congestive Heart Failrue and Rosiglitazone Only: Myocardial Infarction

Congestive Heart Failure

  • Thiazolidinediones, including pioglitazone and rosiglitazone, cause or exacerbate congestive heart failure in some patients.
  • After initiation of these drugs, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema). If these signs and symptoms develop, the heart failure should be managed according to the current standards of care. Furthermore, discontinuation or dose reduction of these drugs must be considered.
  • These drugs are not recommended in patients with symptomatic heart failure. Initiation of these drugs in patients with established NYHA Class III or IV heart failure is contraindicated.

Rosiglitazone Only: Myocardial Infarction

  • A meta-analysis of 52 clinical trials (mean duration 6 months; 16,995 total patients), most of which compared¬†rosiglitazone to placebo, showed rosiglitazone to be associated with a statistically significant increased risk of myocardial infarction. Three other trials (mean duration 46 months; 14,067 total patients), comparing rosiglitazone to some other approved oral antidiabetic agents or placebo, showed a statistically non-significant increased risk of myocardial infarction, and a statistically non-significant decreased risk of death. There have been no clinical trials directly comparing cardiovascular risk of rosiglitazone and pioglitazone, but in a separate trial, pioglitazone (when compared to placebo) did not show an increased risk of myocardial infarction or death.

 


FDA and Industry Communications

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts

Pioglitazone

Rosiglitazone

Additional Information

Updated January 2018