Medication Guide App

Label Changes for:

Duetact (pioglitazone hydrochloride and glimepiride) fixed-dose combination Tablets

August 2011

Changes have been made to the PRECAUTIONS sections of the safety label.

Actos (pioglitazone hydrochloride) Tablets

Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) Tablets 

Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride extended-release) Tablets

Duetact (pioglitazone HCl plus glimepiride fixed-dose combination) Tablets

 

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009 and August 2011

 

August 2011 

 

Actos (pioglitazone hydrochloride) Tablets

WARNINGS AND PRECAUTIONS

Urinary Bladder Tumors
  • Interim results from this study suggested that taking ACTOS longer than 12 months increased the relative risk of developing bladder cancer in any given year by 40% which equates to an absolute increase of 3 cases in 10,000 (from approximately 7 in 10,000 [without ACTOS] to approximately 10 in 10,000 [with ACTOS])

 

Actoplus Met (pioglitazone hydrochloride and metformin hydrochloride) fixed-dose combination Tablets

Actoplus Met XR (pioglitazone hydrochloride and metformin hydrochloride extended-release) fixed-dose combination Tablets

Duetact (pioglitazone hydrochloride and glimepiride) fixed-dose combination Tablets

 

PRECAUTIONS

General

Pioglitazone hydrochloride

  • Interim results from this study suggested that taking ACTOS A duration of therapy longer than 12 months increased the relative risk of developing bladder cancer in any given year by 40% which equates to an absolute increase of 3 cases in 10,000 (from approximately 7 in 10,000 [without ACTOS] to approximately 10 in 10,000 [with ACTOS]) 

 

September 2009 

 

MEDICATION GUIDE

  • Conversion of approved patient package insert to a Medication Guide.

REMS

  • FDA became aware of reports of congestive heart failure in patients being treated with pioglitazone-containing products in both the clinical trial and post-marketing setting.  
  • FDA determined products containing pioglitazone pose a serious and significant public health concern requiring distribution of a Medication Guide.
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