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Takeda Receives FDA Complete Response Letter for the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes
Date:9/4/2009

etic ketoacidosis. ACTOS has not been studied in children and is not recommended for children under the age of 18. ACTOS may be taken alone or with a sulfonylurea, metformin, or insulin.

Important Safety Information About ACTOS

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

Do not take ACTOS if you have active liver disease. Your doctor should perform a blood test to check for liver problems before you start ACTOS and periodically thereafter. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin.

If you are of childbearing age, talk to your doctor before taking ACTOS, as it could increase your chance of becoming pregnant. Talk to your doctor if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood sugar. Some people taking ACTOS may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, anemia, and weight gain. Patients with diabetes should have regular eye exams. If you experience vision problems, consult your doctor immediately. Some patients have experienced visual changes while taking ACTOS.

Some people, particularly women, are at higher risk of having bone fractures while taking ACTOS. Other side effects may include cold-like symptoms, headache, sinus infection, muscle pain, tooth disorder, and sore throat.

Please visit the Takeda Pharmaceuticals North America, Inc. Web site at

SOURCE Takeda Pharmaceutical Company Limited
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2. Takeda Provides Update on the Investigational Fixed-Dose Combination of alogliptin and ACTOS(R) (pioglitazone HCl)
3. Takeda Receives FDA Complete Response Letter for Alogliptin, an Investigational Treatment for Type 2 Diabetes
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