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Takeda Responds to FDA Advisory Committee Recommendation
Date:7/14/2010

nd other public health matters. The FDA frequently convenes its panel of outside experts to provide guidance and recommendations; however, the recommendations of the committee are not a final decision. The FDA will evaluate the committee's decision and their final recommendations will follow.

Takeda remains committed to ACTOS and to the millions of people living with type 2 diabetes. Takeda is the inventor and developer of ACTOS, which was launched commercially in the U.S. in 1999. ACTOS, as labeled, is an effective and appropriate treatment option for many people living with type 2 diabetes. Since its launch, more than 100 million ACTOS family prescriptions have been written, covering more than 10 million patients. 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.

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.

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.

ACTOS is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis.

ACTOS may cause low blood sugar when taken in combination with insulin
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SOURCE Takeda Pharmaceuticals North America, Inc.
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