Home Page >> Emerging Issues >> Darvon and Darvocet
Darvon and Darvocet
In February 2009 an advisory committee to the U.S. Food and Drug Administration (FDA) recommended that the FDA recall Darvon (generic name propoxyphene), a popular painkiller also sold in combination with acetaminophen under the brand name Darvocet (generic drug name propoxyphene and acetaminophen). On its website, the FDA reports more than 3,000 cases of serious problems with Darvon and Darvocet, with most involving suicides, addiction and overdoses. However, the agency has called for a black box warning on the drugs.
On July 7, 2009 the FDA rejected the committee's recommendations to withdraw the pain killers from the market and called for a boxed warning of overdose risk on packages of Darvon, Darvocet and other painkillers containing the drug propoxyphene.
At the same time, the FDA also denied a petition from the consumer advocacy Public Citizen requesting a phased withdrawal of propoxyphene. However, the FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. The agency states that findings from this study, as well as other data, could lead to additional regulatory action.
The FDA advisory panel originally investigated the safety of Darvon and Darvocet in 2006 after Public Citizen petitioned that a Darvon and Darvocet recall be issued to phase the drugs off the market. Public Citizen reported more than 2,000 accidental deaths linked to Darvon and Darvocet since 1981 and further added that Darvon and Darvocet are physically addictive and are no more effective than other safer painkillers, like ibuprofen and acetaminophen.
Public Citizen filed a lawsuit against the FDA in 2008, alleging that the agency was violating the law by failing to act on the Darvon and Darvocet recall petition it filed two years earlier.
Darvon, initially developed by Eli-Lilly and now marketed by two companies--Xanodyne Pharmaceuticals of Kentucky and Qualitest/Vintage Pharmaceuticals of Alabama--was first approved for use in the United States in 1957. Darvon is commonly combined with a dose of acetaminophen and marketed by Xanodyne under the name Darvocet. Both drugs are classified as narcotic pain relievers. Darvocet is one of the most commonly prescribed drugs in the US for treating patients with mild to moderate pain, with more than 20 million prescriptions written in 2007.
The FDA warns the following: Do not use propoxyphene [Darvon] if you have a history of suicidal thoughts or actions. Propoxyphene should never be taken together with a sedative (such as Valium or Xanax) or an antidepressant if you are also drinking large amounts of alcohol. Propoxyphene may be habit-forming and should be used only by the person it was prescribed for.
Side effects that you should report to your doctor or health care professional as soon as possible:
- allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
- breathing difficulties, wheezing
- confusion
- fainting spells
- hallucinations
- severe stomach pain
- yellowing of the skin or the whites of the eyes
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
- dizziness
- drowsiness
- headache
- nausea
- vomiting
Darvon and Darvocet Overdose Legal Help
If you or a loved one has suffered from an overdose or tried to commit suicide, you may qualify for damages or remedies that may be awarded in a possible class action lawsuit. Please click the link below to submit your complaint and we will have a lawyer review your Darvon and Darvocet complaint.
At LawyersandSettlements.com, it is our goal to keep you informed about important legal cases and settlements. We are dedicated to helping you resolve your legal complaints.
Last updated on Aug-5-09
|
DARVON DARVOCET OVERDOSE ARTICLES AND INTERVIEWS
FDA Strengthens Warnings on Darvon and Darvocet
 Rockville, MD: The US Food and Drug Administration (FDA) announced that it has required the manufacturers of products containing propoxyphene (the generic name of Darvon) to strengthen the warnings about the risk of overdose with such products. The warning applies to pain medications, including Darvon and Darvocet. [ Read More ]
YOUR DARVON DARVOCET OVERDOSE STORIES
Publish your Darvon Darvocet Overdose experience here for our readers to learn from.
|
|
Search 10,000 recent cases and settlements
|
