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Label Changes for:

Avandaryl (rosiglitazone maleate/glimepiride) Tablets

February 2011

Changes have been made to the BOXED WARNING, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2011

 

Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin hydrochloride), and Avandaryl (rosiglitazone maleate/glimepiride) Tablets

 

BOXED WARNING

WARNING: CONGESTIVE HEART FAILURE AND MYOCARDIAL INFARCTION
  • A meta-analysis of 52 clinical trials (mean duration 6 months; 16,995 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with a statistically significant increased risk of myocardial infarction. Three other trials (mean duration 46 months; 14,067 total patients), comparing Avandia 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 Avandia and Actos (pioglitazone, another thiazolidinedione), but in a separate trial, Actos (when compared to placebo) did not show an increased risk of myocardial infarction or death

WARNINGS AND PRECAUTIONS

Cardiac Failure
  • Heart Failure in Observational Studies of Elderly Diabetic Patients Comparing Avandia to Actos ...
Adverse Cardiovascular Events
  • Meta-Analysis of Major Adverse Cardiovascular Events in a Group of 52 Clinical Trials (updated)
Fractures
  • ...Other studies suggest that this risk may also apply to men, although the risk of fracture among women appears higher than that among men.

ADVERSE REACTIONS

  • The use of Avandia in combination with insulin may increase the risk of myocardial infarction.
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