Darvon and Darvocet

The FDA has announced that Darvocet and Darvon have been pulled from the market after a recent study showed Darvocet pills and Darvon medication included serious Darvocet side effects, including potentially fatal heart rhythm abnormalities. As well, Darvon and Darvocet overdose have been linked to thousands of deaths each year, although Darvon and Darvocet heart issues were mainly what prompted a Darvon recall and subsequent Darvon and Darvocet lawsuits.

Darvon (Propoxyphene) and Darvocet (Acetaminophen and Propoxyphene) are in a class of drugs called narcotic analgesics or opioids and are prescribed to reduce pain, such as chronic arthritis. In November 2010, Xanodyne Pharmaceuticals Inc, the manufacturers of Darvon and Darvocet, withdrew the pain killers from the market after the FDA said that propoxyphene puts patients at risk of potentially serious or fatal heart rhythm abnormalities.

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 pills are 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. In 2009, about 10 million people were prescribed some form of the drug.

Propoxyphene was first approved by the FDA in 1957 as a prescription pain medication. Since 1978 the agency had two requests to remove Darvon and Darvocet. In January 2009, the Public Citizen's Health Research Group reported that from 2007, 503 deaths were linked by medical examiners to propoxyphene use and that the drug had caused 2,000 accidental deaths in America since 1981.

Darvon was originally introduced by Eli Lilly in the 1950s, and is now marketed by two companies--Xanodyne Pharmaceuticals of Kentucky and Qualitest/Vintage Pharmaceuticals of Alabama. It was first approved for use in the United States in 1957. Darvon became one of America's most popular prescription drugs in the early 1970s, averaging about 39 million prescriptions per year. During that time, research groups began linking Darvon with thousands of deaths and the Health Research Group demanded a federal ban on the drug.

2006: An FDA advisory panel investigates the safety of Darvon and Darvocet after Public Citizen petitions that a Darvon and Darvocet recall be issued to phase the drugs off the market. Public Citizen reports more than 2,000 accidental deaths linked to Darvon and Darvocet since 1981 and further adds that Darvon and Darvocet are physically addictive and are no more effective than some non-prescription painkillers such as ibuprofen and acetaminophen.

2008: Public Citizen files a lawsuit against the FDA, alleging that the agency is violating the law by failing to act on the Darvon and Darvocet recall petition the group filed two years earlier.

January 30, 2009: During testimony before an FDA advisory committee, Sidney Wolfe, M.D., director of Public Citizen's Health Research Group, cites information from the Federal Drug Abuse Warning Network (DAWN) from 2007 that showed 503 deaths linked by medical examiners to propoxyphene use. As many as two-thirds of those deaths were ruled accidental.

February 2009: An advisory committee to the FDA recommends a Darvon (generic name propoxyphene) recall, which was also sold in combination with acetaminophen under the brand name Darvocet (generic drug name propoxyphene and acetaminophen). On its website, the FDA reported more than 3,000 cases of serious problems with Darvon and Darvocet, with most involving reported Darvocet side effects of suicide, addiction and overdose.

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

July 2009: The FDA rejects the committee's recommendations to withdraw the pain killers from the market and calls for a boxed warning of overdose risk on packages of Darvon, Darvocet and other painkillers containing the drug propoxyphene. According to an FDA news release, (July 14, 2009), propoxyphene can treat pain effectively when it is used at recommended doses but can cause fatal overdose if not used according to guidelines. The FDA requires the manufacturers of Darvon and Darvocet to strengthen the warnings on the drugs' labels and to provide a medication guide alerting patients to the importance of following directions for using the medications.

At the same time, the FDA also denies a petition from the consumer advocacy Public Citizen requesting a phased withdrawal of propoxyphene. Public Citizen argues that the drug is more dangerous than acetaminophen alone but no more effective at treating post-operative pain than acetaminophen.

However, the FDA requires a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. The agency stated that findings from this study, as well as other data, could lead to additional regulatory action.

November 2010: Xanodyne Pharmaceuticals Inc. agrees to withdraw the medication from the US market at the request of the FDA. 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.

The FDA says in a statement that the drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks.

The FDA reported that data from the new study show that propoxyphene causes significant changes to the electrical activity of the heart, even when taken at recommended doses.

These changes, which can be seen on an electrocardiogram (ECG, or 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 Darvon or Darvocet 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. According to Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER, once patients stop taking propoxyphene, the risk of heart damage will go away.

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.

Darvon or Darvocet 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

Darvon or Darvocet 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

The FDA is urging patients currently taking Darvon, Darvocet or other generic versions of propoxyphene to consult with their physicians as soon as possible about switching to an alternative medication.

Darvon and Darvocet Legal Help

If you or a loved one has suffered heart rhythm abnormalities and other heart problems while taking Darvocet, Darvon, or any other form of propoxyphene, you should contact a drug recall attorney.

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 Apr-10-14