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U.S. Department of Health and Human Services

Safety

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Pioglitazone hydrochloride

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 

Summary View

 

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 

Summary View

 

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.