Navigation Links
FDA Reviewing Preliminary Safety Information on Actos (pioglitazone)
Date:9/17/2010

SILVER SPRING, Md., Sept. 17 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced it has begun a safety review of the diabetes drug Actos (pioglitazone), after receiving preliminary results from a long-term observational study designed to evaluate the risk of bladder cancer associated with use of this drug.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

The preliminary results are based on five-year data from an ongoing, 10-year observational study by the manufacturer, Takeda Pharmaceuticals North America Inc., San Diego. These early results showed no overall association between Actos exposure and risk of bladder cancer. However, there was an increased risk of bladder cancer in patients with the longest exposure to Actos and in those with the highest cumulative dose of the drug.

At this time, the FDA's review is ongoing. The agency has not concluded that Actos increases the risk of bladder cancer.

Actos (pioglitazone) is used to control blood sugar in patients with type 2 diabetes mellitus. It is in the class of drugs known as peroxisome proliferator-activated receptor (PPAR) agonists. The only other drug in this class is Avandia (rosiglitazone).  The FDA has no clinical information associating Avandia with bladder cancer in patients receiving that drug.  

Patients should talk to their health care professional if they have concerns about Actos. They should not stop taking the drug unless told to do so by their health care professional.

For more information

Ongoing Safety Review of Actos (pioglitazone) and Increased Risk of Bladder Cancer

http://www.fda.gov/Drugs/DrugSafety/ucm226214.htm

Media Inquiries: Karen Riley, 301-796-4674; karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA




'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Reviewing Biomoda Submission for Cancer Screening Study
2. Trubion Announces Preliminary Analysis of Phase IIb Results With TRU-015 in Rheumatoid Arthritis
3. Genomic Health Announces Preliminary Results From a Study of Oncotype DX(TM) in Node-Positive Breast Cancer Patients
4. Preliminary Results of Randomized Pilot Study Show Comparable Efficacy for OrbusNeichs Genous(TM) Bio-engineered R Stent(TM) and Boston Scientifics Taxus(R) Stent in Patients at High Risk of Restenosis
5. Sunesis Pharmaceuticals Reports Preliminary SNS-595 Activity in Ovarian Cancer Clinical Trial at AACR-NCI-EORTC International Conference
6. Pharmion and MethylGene Report Preliminary MGCD0103 Clinical Data at the 2007 AACR-NCI-EORTC International Conference
7. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
8. Vion Pharmaceuticals To Present Preliminary Data on its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) at the American Society of Hematology Meeting
9. Pixantrone Versus Doxorubicin in CHOP-R Therapy for First-line Treatment of Aggressive Non-Hodgkins Lymphoma Preliminary Results Presented at American Society of Hematology (ASH) Annual Meeting
10. Anthera Announces Preliminary Positive Results From Once-Daily A-002 Phase II Cardiovascular Trial
11. Morria Biopharmaceuticals Plc Announces Preliminary Safety and Tolerability Results From Its Phase I Clinical Study of MRX-4 in Allergic Rhinitis Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... 2016  The Senior Care Pharmacy Coalition (SCPC) ... Chairman Jason Chaffetz (R-UT) and Ranking ... hearing , "Developments in the Prescription Drug Market," ... questions about abusive pharmacy benefit manager (PBM) pricing ... Ranking Member Elijah Cummings (D-MD) are diligent, serious ...
(Date:2/4/2016)... , Feb. 4, 2016  Montoya Love is recognized ... the field of Pharmaceuticals. Montoya is the Regulatory Systems ... Manufacturing and selling ... Becton Dickinson provides healthcare institutions, clinical laboratories and ... fifty countries across the globe. ...
(Date:2/4/2016)... -- Mettler-Toledo International Inc. (NYSE: MTD ) today ... the highlights: , Sales in local currency ... year.  Reported sales decreased 3% as currency reduced sales ... earnings per diluted share as reported (EPS) were $4.44, ... EPS was $4.65, an increase of 10% over the ...
Breaking Medicine Technology:
(Date:2/6/2016)... ... February 06, 2016 , ... With the FCPX LUT: Summer ... to their footage. A LUT is a Lookup Table that contains a mathematical formula ... indicated by the table. By manipulating each pixel, LUT's can change each color range ...
(Date:2/6/2016)... , ... February 06, 2016 , ... ... of eating disorder treatment helps to reduce the frequency and level of relapse. ... Recovery Phase: Re-Establishing Healthy Identity and Purpose,” will explore the critical tasks of ...
(Date:2/5/2016)... ... , ... Love is in the air at King Kullen! The local grocer ... This staple for Valentine’s Day is a must-have, and can be picked up with ... only are long-stem roses available, but also other flower bouquets, elegantly wrapped and ready ...
(Date:2/5/2016)... ... February 05, 2016 , ... Today, the Whole-Food Warrior ... that the much-anticipated feature with author Jahnavi Foster, specialist in healthy vegetarian cuisine, will ... , Each week, on his weekly Whole-Food Warrior TV show, Frank Davis highlights Whole-Food ...
(Date:2/5/2016)... ... 05, 2016 , ... The event is being held on April 7, 2016 ... Minn. Triumph Over Parkinson’s will fund nearly $100,000 for research for the care and ... Parkinson’s disease and is the architect of this informative event to raise awareness and ...
Breaking Medicine News(10 mins):