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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

isk of having broken bones (fractures) while taking ACTOS.

When taking ACTOS with insulin or other anti-diabetic medications (especially sulfonylureas), hypoglycemia may occur. Lightheadedness, shakiness, dizziness, or hunger may mean that a patient's blood sugar is too low. Patients should talk to their doctor if low blood sugar is a problem for them.

Some patients have experienced visual changes while taking ACTOS. If patients experience vision problems, they should consult their doctor immediately. Patients should have their eyes checked regularly.

If a patient is of childbearing age, but does not have regular monthly periods, she should talk to her doctor before taking ACTOS, as it could increase her chances of becoming pregnant.

The most common side effects of ACTOS include cold-like symptoms, headache, sinus infection, muscle pain, and sore throat.

Patients should tell their doctor about all the medicines, vitamins, and supplements they take. ACTOS and some other medicines can affect each other. Patients may need to have their doses of ACTOS or certain other medicines changed.

It is not known if ACTOS can harm an unborn, or nursing, baby. A patient should talk to her doctor if she is pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

Individuals are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For complete prescribing information, including warning about heart failure, and Medication Guide, please visit www.ACTOS.com.

Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Tak
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SOURCE Takeda Pharmaceuticals North America, Inc.
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