Takeda Responds to U.S. Food and Drug Administration Update to Safety Review of ACTOS (pioglitazone HCl)

DEERFIELD, Ill., June 15, 2011 /PRNewswire/ -- Following an announcement today from the U.S. Food and Drug Administration (FDA) regarding an update to its safety review of ACTOS, Takeda Pharmaceuticals North America, Inc. (Takeda) is confident in the therapeutic benefits of ACTOS and its importance as a treatment for type 2 diabetes. The company remains committed to ACTOS and ACTOS-containing medications, and to the millions of people living with the disease.

Takeda is dedicated to patient safety, and to ensuring that patients and physicians have accurate information regarding ACTOS. Takeda is committed to ongoing clinical research to understand and investigate potential safety concerns, and, working with appropriate regulatory agencies, is currently supporting a ten-year epidemiological study, started in 2002 by the University of Pennsylvania (U. of Penn.) and Kaiser Permanente Diabetes Registry, Northern California (KPNC), investigating the questions raised about ACTOS and bladder cancer. Takeda has been working with the FDA and European Medicines Agency (EMA) and has provided them with interim data from this study on a regular basis. Takeda is committed to supporting this study through its conclusion at the end of 2012 and will report on the final results upon completion.  

In the interim analysis of this epidemiologic data, published in Diabetes Care April 2011, the primary endpoint showed that treatment with ACTOS was not associated with a statistically significant increase in the incidence of bladder cancer. The investigators reported that "short-term use of pioglitazone was not associated with an increased incidence of bladder cancer, but use for more than two years was weakly associated with increased risk."  

Based on its recent data review, FDA has informed the public that "...use of the diabetes medication ACTOS (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer."  Takeda is working with FDA to make appropriate updates to the prescribing information.

Takeda encourages patients with questions to speak with their health care providers. Takeda has consistently emphasized the importance of physician education and patient safety in communications involving ACTOS, and has prioritized communicating the appropriate use of ACTOS in patients with type 2 diabetes.

ACTOS has been an effective and appropriate treatment option, along with diet and exercise, to improve blood sugar (glucose) control for many people living with type 2 diabetes and has been prescribed for more than 10 million patients to date. Since its launch, more than 100 million ACTOS prescriptions have been written globally.

About ACTOS (pioglitazone HCl) Indications and Usage

ACTOS (pioglitazone HCl) is a prescription medication used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis.

Important Safety Information

Warning: Heart Failure

ACTOS is not for everyone. ACTOS can cause or worsen heart failure. Heart failure means that the heart does not pump blood well enough. Patients should talk to their doctor immediately if they experience unusually fast weight gain, fluid retention (swelling), shortness of breath, or unusual tiredness. Certain patients with symptoms of heart failure should not start taking ACTOS. Patients should not take ACTOS if they have severe heart failure.

Patients should not take ACTOS if they are allergic to any of its ingredients.

ACTOS may cause liver problems. Patients should talk to their doctor immediately if they experience unexplained nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine, or yellowing of the skin or eyes as these could be symptoms of liver damage.

Women are at higher risk 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 Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology, and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

SOURCE Takeda Pharmaceuticals North America, Inc.