Darvon Quick Reference Guide
Generic Name
• Propoxyphene
• Acetaminophen
Date Approved by the FDA
• July 26, 2002
Manufacturer
• Aaipharma LLC
• Xanodyne Pharmaceuticals
Status
• Removed from market
Approved Use
• Relief of pain
Serious side effects
• Cardiac disorders
• Arrhythmia
• Bradycardia
• Cardiac/respiratory arrest
• Congestive arrest
• Congestive heart failure (CHF)
• Tachycardia
• Myocardial infarction (MI)
• Suicide
• Death
• Lightheadedness
• Dizziness
• Sedation
• Nausea
• Vomiting
What are Darvon and Darvocet?
Darvocet, originally developed by Eli Lilly & Co. but now marketed by Xanodyne Pharmaceuticals, is a combination of propoxyphene and acetaminophen. Darvon, also marketed by Xanodyne Pharmaceuticals, contains propoxyphene alone. Both products are used to treat mild to moderate pain.
Who takes them, and for what conditions?
People that need relief from mild to moderate pain with or without fever. Darvon and darvocet are commonly prescribed as part of a treatment regimen to manage arthritis pain and other painful conditions.
If you or a loved one have taken Darvon and/or Darvocet and have experienced side effects, call us at 1-888-341-1405 or contact us online for a consultation.
Darvon and Darvocet causing Fatal Heart Rhythms
In January 2009, an FDA advisory panel recommended that the FDA remove Darvon, Darvocet and similar products from the market.
Instead of removing the products from the market, the FDA allowed continued marketing of Darvocet and other propoxyphene products but required that a new warning is added to the drug label concerning the risk of a fatal overdose. While the new warning did not include mention of heart rhythm problems, the FDA required Xanodyne to conduct a new safety study on the effects of propoxyphene on the heart.
In November 2010, the FDA recommended that the manufacturer removes these products from the market based on data from the required safety study. The results of the study showed that when propoxyphene was taken at therapeutic doses, there were significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval. These changes can increase the risk for serious abnormal heart rhythms. Because it is not possible to monitor for the risk of a fatal cardiac arrhythmia, the FDA to asked that Darvocet, along with Darvon, be withdrawn from the market. The FDA also said it was asking the manufacturers of generic propoxyphene-containing products to remove those products from the market.
What can you do?
If you or someone you love took Darvon or Darvocet and suffered from abnormal heart rhythm injury or other serious side effects, you have valuable legal rights. Please call our toll-free number ( 1-888-341-1405) to discuss your case with one of our Darvon or Darvocet injury lawyers.
Trust our Massachusetts Darvon & Darvocet injury attorneys to help
Contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts drug and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.
