Navigation Links
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 or call 1-800-FDA-1088.

For complete prescribing information, including warning about heart failure, and Medication Guide, please visit

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

SOURCE Takeda Pharmaceuticals North America, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Takeda to Acquire Nycomed
2. Amylin and Takeda Voluntarily Suspend Clinical Activities in Obesity Trial
3. Intra-Cellular Therapies and Takeda Enter into Worldwide Collaboration to Develop and Commercialize Compounds for Schizophrenia
4. Handa Pharmaceuticals Announces Submission of Its First-to-File ANDA for Takedas DEXILANT®
5. Takeda Submits New Drug Application in the U.S. for Azilsartan Medoxomil Plus Chlorthalidone, an Investigational Fixed-Dose Combination for the Treatment of Hypertension
6. Takeda Enters Into Global Strategic Partnerships With Covance and Quintiles
7. Takeda Completes Settlements With All Defendants in U.S. Patent Litigation Involving ACTOS® (pioglitazone HCI), ACTOplus met® (pioglitazone HCl and metformin HCl) and duetact® (pioglitazone HCl and glimepiride)
8. Takeda Responds to Announcement about Suspension of Rosiglitazone Marketing Authorization in Europe and Restrictions in the U.S.
9. Arthritis Foundation and Takeda Launch First-Ever National Gout Public Service Announcement (PSA) Campaign, Urging People Living With Gout to Keep Enjoying Lifes Simple Pleasures
10. Orexigen® Therapeutics and Takeda Enter Into Partnership to Commercialize Contrave® in North America
11. Takeda Responds to FDA Advisory Committee Recommendation
Post Your Comments:
(Date:11/26/2015)... , November 26, 2015 3D ... by 2022, according to a new report by Grand View ... Kidney Disease (CKD) which demands kidney transplantation is expected to ... cost effective substitute for organ transplantation. --> 3D ... by 2022, according to a new report by Grand View ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 ... has announced the addition of the  ... in the Global Cell Surface Testing ... Opportunities" report to their offering.  ... the addition of the  "2016 Future ...
(Date:11/26/2015)... Nov. 26, 2015 Research and Markets ( ... "Advanced Wound Care Market by Type (Dressings, Therapy Devices, ... (In-Patient Facility, Out-Patient Facility), and Geography - Global Forecast ... --> --> The purpose ... and forecast of the global advanced wound care market. ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... November 26, 2015 , ... Indosoft Inc., developer and distributor of the ... to improve system efficiency and reliability. , The new Q-Suite 6 platform is based ... system avoids locking itself into a specific piece of software for many key components ...
(Date:11/25/2015)... ... November 25, 2015 , ... Medical Solutions, one of the ... stellar workplace culture with the company’s Cincinnati office being named a finalist among ... was named a finalist in Cincinnati Business Courier’s 13th annual Greater Cincinnati Best ...
(Date:11/25/2015)... , ... November 25, 2015 , ... For the first ... “ Two Organizations, One Beat ” campaign. The partnership between the two groups began ... aid in MAP International’s cause. , MAP International was founded in 1954 and is ...
(Date:11/25/2015)... ... November 25, 2015 , ... Wimbledon Health Partners, the industry ... Wimbledon Athletics Facebook page to educate the public, parents and school athletic ... 2,000 people under the age of 25 die from sudden cardiac arrest every ...
(Date:11/25/2015)... ... November 25, 2015 , ... Beddit® has launched a new ... systems. The new app features a more intuitive SleepScore™ that rates sleep quality on ... slept. The SleepScore is created by a proprietary algorithm. Beddit analyzes the data to ...
Breaking Medicine News(10 mins):