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:2/8/2016)... Feb. 8, 2016  Unilife Corporation ("Unilife" or "Company") (NASDAQ: ... injectable drug delivery systems, today announced that it will release ... December 31, 2015 after market close on February 9, 2016. ... call to discuss these financial results.    About ... --> About Unilife Corporation ...
(Date:2/8/2016)... NORTHBROOK, Ill. , Feb. 8, 2016  Astellas Pharma ... today announced the promotion of James Robinson as ... the company,s operations in North and South America ... president, Astellas Pharma US, representing the commercial organization in ... assumed in 2013. Masao Yoshida , who ...
(Date:2/8/2016)... Palatin Technologies, Inc. (NYSE MKT: PTN), ... for the treatment of diseases with significant unmet ... the United States Patent and Trademark Office (USPTO) ... Patent Application Serial Number 14/313,258 (the ,258 application).  ... female sexual dysfunction using the formulation and dose ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... ... Remember the old saying “rub some dirt on it”? Perhaps you should try ... Clay” the health benefits of integrating clay into a daily diet are numerous, as ... motivational speaker, Perry A~ has since dedicated her life to learning about the benefits ...
(Date:2/8/2016)... , ... February 08, 2016 , ... ... wide variety of organizations. DocuSyst provides a cloud hosted environment for FileHold ... installations include integration with various 3rd party applications using the FileHold web services ...
(Date:2/8/2016)... ... 2016 , ... GrassrootsHealth published data from its D*action public ... in the GrassrootsHealth cohort with substantially higher vitamin D levels than a cohort ... states Carole Baggerly, Director of GrassrootsHealth, “the safety and benefits of vitamin ...
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... TopConsumerReviews.com recently ... in Mole removal products. , Moles are derived from a cluster of melanin when ... all the wrong places and create a lifetime of embarrassment. Historically, mole removal ...
(Date:2/8/2016)... ... , ... Guruji Mahendra Kumar Trivedi is offering 3 days of accelerated personal ... birthday on February 10th. During this time, people can achieve better health, greater ... people from over 40 different countries as an “ordinary man with an extraordinary gift.” ...
Breaking Medicine News(10 mins):