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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

p>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 or other oral antidiabetic drugs. 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 people taking ACTOS may experience flulike symptoms, mild-to-moderate swelling of legs and ankles, anemia, and weight gain.

If a patient is of childbearing age, they should talk to their doctor before taking ACTOS, as it could increase their chance of becoming pregnant. Patients should talk to their doctor if they are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.

A patient should not take ACTOS if they have active liver disease. A doctor should perform a blood test to check for liver problems before a patient starts ACTOS and periodically thereafter. Patients should talk to their doctor immediately if they experience nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes.

Patients with diabetes should have regular eye exams. If a patient experiences vision problems, they should consult with their 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.

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.

Takeda encourages those with questions to speak with their health care provider. For the U.S. Complete Prescribing Information, including warnings about heart failure and M
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SOURCE Takeda Pharmaceutical North America, Inc.
Copyright©2010 PR Newswire.
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