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Takeda Responds to U.S. Food and Drug Administration Update to Safety Review of ACTOS (pioglitazone HCl)
Date:6/15/2011

0;Takeda is working with FDA to make appropriate updates to the prescribing information.

Takeda encourages patients with questions to speak with their health care providers. Takeda has consistently emphasized the importance of physician education and patient safety in communications involving ACTOS, and has prioritized communicating the appropriate use of ACTOS in patients with type 2 diabetes.

ACTOS has been an effective and appropriate treatment option, along with diet and exercise, to improve blood sugar (glucose) control for many people living with type 2 diabetes and has been prescribed for more than 10 million patients to date. Since its launch, more than 100 million ACTOS prescriptions have been written globally.

About ACTOS (pioglitazone HCl) Indications and Usage

ACTOS (pioglitazone HCl) is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis.

Important Safety Information

Warning: Heart Failure

ACTOS is not for everyone. ACTOS can cause or worsen heart failure. Heart failure means that the heart does not pump blood well enough. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness. Certain patients with symptoms of heart failure should not start taking ACTOS. Patients should not take ACTOS if they have severe heart failure.

Patients should not take ACTOS if they are allergic to any of its ingredients.

ACTOS may cause liver problems. Patients should talk to their doctor immediately if they experience unexplained nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes as these could be symptoms of liver damage.

Women are at higher r
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SOURCE Takeda Pharmaceuticals North America, Inc.
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