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Takeda Responds to Announcement about Suspension of Rosiglitazone Marketing Authorization in Europe and Restrictions in the U.S.
Date:9/23/2010

ng with type 2 diabetes. The PROactive trial demonstrated that although there was no statistically significant difference between ACTOS and standard-of-care alone for the primary endpoint, there was no increase in mortality or total macrovascular events with ACTOS. This safety information has been included in both the FDA-approved product label and EMA-approved Summary of Product Characteristics (SPC) since 2007, providing patients and health care professionals with additional relevant information regarding the CV safety profile of ACTOS.

Takeda is the inventor and developer of ACTOS, which was launched commercially in 1999. ACTOS, as labeled, is an effective and appropriate treatment option for many people living with type 2 diabetes. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new or worsen heart failure. In clinical trials using ACTOS in monotherapy, the most common adverse events (greater than or equal to 5%) were upper respiratory tract infection, headache, sinusitis, myalgia, tooth disorder, aggravated diabetes mellitus and pharyngitis. Please see additional important safety information continued below.

About ACTOS® (pioglitazone HCl) Indications and Usage

ACTOS is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS has been studied as a monotherapy and in combination with sulfonylurea, metformin, or insulin. ACTOS should always be used according to Health Care Provider directions and its Complete Prescribing Information.

Important Safety Information

ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause new, or worsen, heart failure. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness.

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SOURCE Takeda Pharmaceutical North America, Inc.
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