Navigation Links
Xanodyne Agrees to Withdraw Propoxyphene From the U.S. Market

SILVER SPRING, Md., Nov. 19, 2010 /PRNewswire-USNewswire/ -- Xanodyne Pharmaceuticals Inc., which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed generic manufacturers of Xanodyne's decision and they will be removing their propoxyphene-containing products from the market as well.


The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.  

"FDA is pleased by Xanodyne's decision to voluntarily remove its products from the U.S. market," said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER). "These new heart data significantly alter propoxyphene's risk-benefit profile. The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."

The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.

Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxyphene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

Since 1978, the FDA has received two requests to remove 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.

"With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart," said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. "However, long-time users of the drug need to know that these changes to the heart's electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away."

Xanodyne is based in Newport, Ky.

For more information:

Propoxyphene-Containing Products

Media Inquiries: Karen Riley, 301-796-4674,

Consumer Inquiries: 888-INFO-FDA

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

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:
(Date:11/25/2015)... , Nov. 25, 2015  Amgen (NASDAQ: AMGN ... Application (BLA) with the United States ... 501, a biosimilar candidate to Humira ® (adalimumab). ... application submitted to the FDA and represents Amgen,s first ... Sean E. Harper , M.D., executive vice president of ...
(Date:11/25/2015)... , Nov. 25, 2015 AAIPharma ... planned investment of at least $15.8  Million to ... Wilmington, NC . The expansion will ... to meet the growing demands of the pharmaceutical ... site expansion will provide up to 40,000 ...
(Date:11/25/2015)... N.Y. , Nov. 25, 2015  Henry Schein, ... and services to office-based dental, medical and animal health ... (GNYDM) Meeting the Henry Schein ConnectDental® Pavilion , ... broadest array of open solutions designed to help any ... Click here for a schedule of experts ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... , ... A team of Swiss doctors has released a report on mesothelioma ... posted the findings on the website. Click here to read the details now. ... patients who were treated with chemotherapy followed by EPP surgery. Among the 106 patients ...
(Date:11/27/2015)... , ... November 27, 2015 , ... Lizzie’s Lice Pickers ... company is offering customers 10% off of their purchase of lice treatment product. In ... full price. According to a company spokesperson. “Finding lice is a sure way to ...
(Date:11/27/2015)... ... ... No.1 Herpes-only dating community in the world, revealed that over 50% of its members are ... people under the age of 50 – or 67% of the population - are infected ... HSV-1 infection . , "The data shocks us highly!" said Michelle Li, Co-Founder of ...
(Date:11/27/2015)... ... ... A simply groundbreaking television series, "Voices in America", which is hosted by Hollywood legend, ... that are presently affecting Americans. Dedicated to providing the world with a wide variety ... consumers focus on, one episode at a time. , In the latest installment ...
(Date:11/27/2015)... ... 2015 , ... CBD College is proud to announce that on ... accreditation to its Diagnostic Medical Sonography program. CBD College is honored to join this ... colleges and universities in the state of California make the cut. CBD College is ...
Breaking Medicine News(10 mins):