Navigation Links
Xanodyne Agrees to Withdraw Propoxyphene From the U.S. Market
Date:11/19/2010

ve propoxyphene from the market.  Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug's cardiac effects would be relevant in weighing its risks and benefits.

In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway.

In July 2009, the FDA decided to permit continued marketing, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The agency now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (EKG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Xanodyne Announces Planned President & CEO Succession
2. Ferring Acquires LYSTEDA(TM) From Xanodyne Pharmaceuticals, Inc.
3. Xanodyne Announces Renewed Focus on Pain Management Market
4. Xanodyne Expands U.S. Sales Force and Launches Zipsor(TM) (diclofenac potassium) Liquid Filled Capsules
5. Xanodyne Raises $50 Million in Equity Financing to Support Emerging Product Portfolio
6. Boston Scientific Agrees to Sell Neurovascular Business to Stryker
7. Abbott Laboratories Agrees to Withdraw Its Obesity Drug Meridia
8. Warner Chilcott Agrees to Terminate Existing Co-Promotion Agreement and Acquire U.S. Rights to Enablex® Overactive Bladder Treatment for $400 Million in Cash
9. Forest Pharmaceuticals Agrees to Guilty Plea for Violating FDA Laws
10. Graymark Healthcare Agrees to Sell Pharmacy Division to Walgreens Creating Pure Play Sleep Apnea Company
11. Fox Insurance Agrees to Pay Delinquent Medicare Part D Claims After Action by Senators Baucus, Grassley, CMS and NCPA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , January 15, 2014 BreedIT Corp ... exclusive worldwide distributor of highly sophisticated agro-breeding solutions for ... 7, 2014, the Company,s board of directors appointed chemistry ... as its new member of the board. ...
(Date:1/15/2014)... Jan. 15, 2014  In an unprecedented effort to curb the spread ... and other transport vehicles, an advanced and portable UV germicidal lamp ... the first time. In order to prevent EMS ... pathogens, West Palm Beach Fire Rescue is ...
(Date:1/15/2014)... WOONSOCKET, R.I. , Jan. 15, 2014 MultiCell ... has filed a U.S. provisional patent application concerning composition ... formulations to achieve targeted tumor cell death.  ... very small noncoding double stranded RNA molecules (VSRNAs) which ...
Breaking Medicine Technology:BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 2BreedIT (OTC: BRDT) Appoints Chemistry and Pharmaceutical Industry Expert Dr. Ben-Zion Weiner to Its Board of Directors 3Superbugs No Longer Ride In Rescue Vehicles 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 2MultiCell Technologies Files Patent Application Covering New Class of RNA Therapeutics 3
(Date:7/10/2014)... The benefits of medical imaging far outweigh the ... Right Way, with The Right Radiation Dose. However, overuse ... Mayo Clinic is leading a collaborative effort to ensure ... published online in the Journal of Patient Safety ... Joint Commission, the Intersociety Accreditation Commission, and the Centers ...
(Date:7/10/2014)... For decades, health-conscious people around the globe have ... figuring this was one of the paths to good ... clinical trials of antioxidant supplements have repeatedly dashed the ... their cancer risk. Virtually all such trials have ... In fact, in several trials antioxidant supplementation has been ...
(Date:7/10/2014)... Men who experience hot flashes are unlikely to ... from their silent suffering if they are willing ... a Baylor University case study., After seven weeks of ... hot flashes following prostate cancer surgery showed a drastic ... impressive improvement in sleep quality, according to the study., ...
(Date:7/9/2014)... MA -- Vasectomy was associated with a small increased ... advanced or lethal prostate cancer according to a new ... researchers found that the association remained even among men ... of lethal cancer cannot be explained by diagnostic bias. ... date to look at the link between vasectomy and ...
(Date:7/9/2014)... cancer, researchers have uncovered mutations in a cell-signaling pathway ... knowledge may expand treatments for patients because drugs targeting ... are in clinical trials. , Reporting July 9 in ... (TCGA), including researchers at Washington University School of Medicine ... studied tumors from 230 patients with lung adenocarcinoma. , ...
Breaking Medicine News(10 mins):Health News:Mayo Clinic calls for standardization of safe imaging protocols for children 2Health News:How antioxidants can accelerate cancers, and why they don't protect against them 2Health News:Men's hot flashes: Hypnotic relaxation may ease the discomfort men don't talk about 2Health News:Men's hot flashes: Hypnotic relaxation may ease the discomfort men don't talk about 3Health News:Men's hot flashes: Hypnotic relaxation may ease the discomfort men don't talk about 4Health News:Vasectomy may increase risk of aggressive prostate cancer 2Health News:Lung cancer study hints at new treatments 2
... CHICAGO, June 24 Bally Total Fitness Holding,Corporation today ... its Chief Executive Officer, effective July 1. Mr. Sheehan ... Directors., Mr. Sheehan, age 46, served as the ... serving as Chief Operating Officer, Mr. Sheehan,served as Executive ...
... control symptoms better, studies show , , TUESDAY, June 24 ... delivery system for an older drug appear to hold ... In the first study, patients taking the drug SLV308 ... tremors and slowness of movement. The results also indicate ...
... announced today Reproductive Health Matters , May 2008 ... Promoting Sexual and Reproductive rights". Under conditions of global ... growing numbers of refugees and internally displaced persons (IDPs) ... right to have rights,. By the end of ...
... Devices known as brain-machine interfaces could someday be ... prosthetic limbs with just their thoughts. Now, University of ... devising a way for computerized devices not only to ... with the brain as it learns. , Instead of ...
... but doing little to ... within the facility, CHICAGO, June 24 The American ... survey asking 1,000 women,their opinions on medical spas. Findings revealed ... customers of these facilities.,Yet half of those women are compromising ...
... The Rehabilitation Institute,of Chicago and MediCom Worldwide, Inc. ... July 18th and 19th. The meeting will be ... University in Chicago., This year, the conference ... scientific agenda will focus on the latest information,issues, ...
Cached Medicine News:Health News:Bally Total Fitness Announces New Chief Executive Officer 2Health News:New Hope for Parkinson's Patients 2Health News:May 2008 issue on conflict and crisis settings: Promoting sexual and reproductive rights 2Health News:Researchers develop neural implant that learns with the brain 2Health News:Researchers develop neural implant that learns with the brain 3Health News:Millennials' Medspa Influence 2Health News:3rd Annual Conference on Pain Jointly Sponsored By Rehabilitation Institute of Chicago and MediCom Worldwide, Inc. 2
Elisa strip reader...
Iems Incubator/Shaker expansion module for 2 module incubator/shaker. high performance microplate incubator and orbital shaker. It's superior temperature control and efficient orbital shaking reduce ...
... Millennium 2000 is a unique microprocessor controlled ... microplates in either 96 or 384 well ... via the control panel and all are ... visible under the clear protective cover. The ...
Modular flow cytometer with all options....
Medicine Products: