On 11/19/2010 Xanodyne Pharmaceuticals Inc. that markets Darvon (Darvon N 100 mg), which is also known as Darvon N 100, and Darvocet, the brand version of the prescription pain drug propoxyphene, has agreed to remove the drug from the United States market at the request of the US FDA. The FDA has also advised the generic makers of propoxyphene-containing drugs of Xanodyne’s decision and asked that they voluntarily remove their products as well.
The FDA sought market removal of propoxyphene immediately after obtaining new clinical data showing that the medicine puts patients at risk of potentially critical or even fatal cardiovascular rhythm abnormalities. As a result of these data, combined with other information, which include new epidemiological data, the agency concluded that the risks of the medication outweigh the advantages.
“The FDA is satisfied by Xanodyne’s decision to voluntarily withdraw its drugs from the US market,” said John Jenkins, M.D., director of the Office of New Drugs in the Food and Drug Administration’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 Food and Drug Administration is notifying health care professionals to avoid prescribing propoxyphene to their patients, and patients who are at this time using the drug need to contact their health care professional as soon as possible to discuss switching to another pain management remedy.
What is the problem with Darvon?
Darvon is used to treat mild to moderate pain. It is also used for pain before, during, and after surgery. It was the 12th most prescribed drug in 2004 with almost 23 million prescriptions written. In February 2006, the Public Citizen urged the FDA to ban both Darvon and Darvocet, a popular painkiller that combines Propozyphene and Acetaminophen. Over 10,000 deaths, at least 2,110 of those being accidental overdoses, have been reported after the use of Darvon and Darvocet.
Side Effects of Darvon
There are a variety of side effects associated with Darvon. Our firm is pursing the following types of serious, life-threatening side effects:
- Accidental Overdose
- Cardiac Emergency
Do I Have a Darvon Lawsuit?
The Schmidt Firm, PLLC is currently accepting Darvon and Propxyphene side effect cases in all 50 states. If you or somebody you know has taken Darvon and suffered a serious side effect, you should contact our firm immediately for a free case consultation. Please click here to contact our Dangerous Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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