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.
