Navigation Links
Takeda Responds to U.S. Food and Drug Administration Update to Safety Review of ACTOS (pioglitazone HCl)
Date:6/15/2011

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." 
'/>"/>

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

Page: 1 2 3 4

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:
*Name:
*Comment:
*Email:
(Date:8/22/2014)... , Aug. 22, 2014 Research ... "Global and Chinese Particulate Respirators Industry Report 2014" ... Global and Chinese Particulate Respirators Industry Report 2014 is ... of the global particulate respirators industry with a focus ... basic overview of the industry including definitions, classifications, applications ...
(Date:8/22/2014)... DUBLIN , August 22, 2014 ... of Hospital TVs Today Lincor announced general ... Patient Engagement solution that delivers a range of education, ... sets.      (Logo: http://photos.prnewswire.com/prnh/20140822/702945) , ... in defining point of care patient engagement to bedside ...
(Date:8/22/2014)... 2014 /PRNewswire/ - SQI Diagnostics Inc. (TSX-V: SQD), ... proprietary technologies and products for advanced microarray diagnostics, ... Master Service Agreement to contract with a UK-based ... During the initial phase of this agreement, SQI ... prototype of one of the customer,s assays, operational ...
Breaking Medicine Technology:Global and Chinese Particulate Respirators Industry Report 2014 2Lincor Unveils Next Generation TV-based Patient Engagement Solution 2SQI Diagnostics Contracted to Automate Pathogen Detection Assays 2SQI Diagnostics Contracted to Automate Pathogen Detection Assays 3
(Date:8/22/2014)... DC (PRWEB) August 22, 2014 Paying ... little easier in the coming year for four nurse ... the National League for Nursing Foundation for Nursing ... – will share $28,000, $10,000 more than in 2013, ... Ann Kerr Endowment and Elizabeth Isaac Marcil Endowment Funds, ...
(Date:8/22/2014)... August 22, 2014 Eagerly embracing intended ... fertility destination, and now offers the top male infertility ... infertility specialists. The fertility network of IVFinMexico.com ... to world-class reproductive care, female and male infertility, advanced ... to the standards so eminently set by company CEO ...
(Date:8/22/2014)... 2014 (HealthDay News) -- An intensive effort to sterilize feral ... shelter in Florida and euthanized, a new study reveals. ... slow their intake into animal control," Dr. Julie Levy, a ... of Veterinary Medicine, said in a university news release. ... a big impact," she explained, "so we wanted to pick ...
(Date:8/22/2014)... A national leader in home delivery of medical supplies, ... grow. , Headquarters for the provider of sterile-use catheters and ... 8516 N.W. Expressway in Oklahoma City. , Rapid growth ... places to work by OKCBiz magazine – demanded more space ... the past two years, and staff count grew 30 percent ...
(Date:8/22/2014)... Home Care Assistance of Centennial , ... is proud to announce the next installment in its ... feature Dr. Suzanne Steinbaum, attending cardiologist and Director of ... York City, National Spokesperson for the American Heart Association’s ... the issues surrounding women and heart disease, what heart ...
Breaking Medicine News(10 mins):Health News:NLN Foundation for Nursing Education Announces 2014 Faculty Scholarship Awards 2Health News:NLN Foundation for Nursing Education Announces 2014 Faculty Scholarship Awards 3Health News:Mexico Now Offers Top Program for Couples Suffering from Male Infertility 2Health News:Mexico Now Offers Top Program for Couples Suffering from Male Infertility 3Health News:Mexico Now Offers Top Program for Couples Suffering from Male Infertility 4Health News:Neutering Project Curbed Feral Cat Population 2Health News:Fast-growing 180 Medical Moves Into New 60,000-square-foot Office in Oklahoma City 2Health News:Home Care Assistance of Centennial to Host Webinar on Heart Health, Featuring Dr. Suzanne Steinbaum 2Health News:Home Care Assistance of Centennial to Host Webinar on Heart Health, Featuring Dr. Suzanne Steinbaum 3
... FRANCISCO, Jan. 28 Rodan + Fields Dermatologists, the,clinical skincare ... and Kathy Fields, M.D., is pleased to,announce the recent addition ... "Rodan + Fields is the most exciting ... retail, we should expect their future to,be bright," says Henry. ...
... The International Medical Interpreters Association (IMIA) unveiled ... its organization. "Our revised bylaws do not stipulate ... distributed among different states and this initiative will ... President.The organization will now have a key representative ...
... Jan. 28 Dr. Michael Forster of the ... of the University of Southern California,s ... may not be a key to living longer. ... researchers were recently published in several scientific journals ...
... 28 The Frost & Sullivan ,2009 European ... Award, is presented to VTS Medical Systems, LLC, ... needs of European hospitals with its value-added products ... ergonomically designed VividImage(R) series, the company is set ...
... 28 Cardiogenesis Corporation (Pink Sheets: CGCP), ... ischemic cardiac disease and the market leader ... sponsored an educational symposium titled "Advancements in ... attended by over 40 cardiothoracic surgeons.The Program ...
... Resubmission Within 60 Days-MISSISSAUGA, ON, Jan. 28 /PRNewswire-FirstCall/ ... drug development company focused on the research and ... the skin using its topical and transdermal drug ... completed all of the studies that will support ...
Cached Medicine News:Health News:Direct Selling Luminary, Robert M. Henry, Partners With Rodan + Fields(R) Dermatologists as Strategic Business Advisor 2Health News:International Medical Interpreter Association Appoints IMIA State Representatives 2Health News:UNT Health Science Center Researchers Discover Eating Less May Not Increase Life Expectancy 2Health News:UNT Health Science Center Researchers Discover Eating Less May Not Increase Life Expectancy 3Health News:Frost & Sullivan Bestows Product Line Strategy Leadership Award to VTS Medical Systems, LLC 2Health News:Frost & Sullivan Bestows Product Line Strategy Leadership Award to VTS Medical Systems, LLC 3Health News:Frost & Sullivan Bestows Product Line Strategy Leadership Award to VTS Medical Systems, LLC 4Health News:Cardiogenesis Announces Successful Educational Symposium at Society of Thoracic Surgeons Meeting in San Francisco 2Health News:Cardiogenesis Announces Successful Educational Symposium at Society of Thoracic Surgeons Meeting in San Francisco 3Health News:Cardiogenesis Announces Successful Educational Symposium at Society of Thoracic Surgeons Meeting in San Francisco 4Health News:Nuvo Research Announces Successful Completion Of All Pennsaid(R) Studies 2Health News:Nuvo Research Announces Successful Completion Of All Pennsaid(R) Studies 3Health News:Nuvo Research Announces Successful Completion Of All Pennsaid(R) Studies 4
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: