Please note that the lawyers at Saiontz & Kirk, P.A. are no longer taking on new cases involving Darvocet. The content on this page is provided for informational purposes only.

The popular painkillers Darvon and Darvocet were pulled from the market in November 2010, after the FDA determined that side effects of propoxyphene, the active ingredient in both drugs, place users at a risk for serious and potenitally life-threatening heart problems.

However, information has been available for decades that should have caused the drug makers to withdraw Darvocet and Darvon from the market or at least warn about the potential risk of Darvon and Darvocet problems.

New cases are no longer being accepted by Saiontz & Kirk, P.A. This page is maintained for informational purposes only.


1957: The FDA approved propoxyphene, which is the active ingredient in Darvon. The medication was introduced in an attempt to find a less addictive, yet equally effective alternative to codeine. However, the medication is actually not as potent as codeine and may be no more effective than two aspirin.

1973 – 1975: Darvon sold as many as 39 million prescriptions a year during this period, making it one of the most commonly prescribed pain killer in the United States.

1976: Approval for Darvocet was received, which combined the active ingredient in Darvon (propoxyphene) with acetaminophen (the active ingredient in Tylenol). Darvocet quickly grew to become a top selling medication as well.

1978: The consumer interest group Public Citizen filed the first petition with the FDA for a Darvon and Darvocet ban to be issued or for tight restrictions to be placed on the medication. The petition was based in part on potential Darvocet heart risks, a lack of effectiveness and a number of Darvon and Darvocet deaths associated with the medications.

Despite information that should have led to Darvon and Darvocet being pulled more than 30 years ago, the drugs were allowed to stay on the market with stronger warnings that advise not to prescribe propoxyphene to suicidal or addiction prone patients, and warning patients not to exceed the recommended dosage and to limit alcohol use on Darvon and Darvocet.

2005: The British government ordered a phased Darvon and Darvocet withdrawal from the market due to the increased risk of health problems from the medications. However, the medication continued to be marketed in the United States.

Because a recall was not also issued in the United States at this time, an additional 120 million prescriptions of Darvon and Darvocet were allowed to be filled in this country, which likely resulted in approximately 2,000 deaths according to some estimates.

2006: The consumer group Public Citizen once again filed a petition for a Darvon and Darvocet recall to be issued due to potential health problems, nearly 30 years after their first petition was filed. The petition cited a high level of toxicity, a substantial number of both accidental and intentional deaths on Darvocet and Darvon and the medications general ineffectiveness as a pain killer.

At that time, Public Citizen pointed out that Darvon and Darvocet heart events were marked by prolongation of the QRS complex on an electrocardiogram, which can increase the risk for abnormal heart rhythm. They also noted that 76% of the deaths from Darvocet and Darvon overdose were a result of cardiac toxicity.

2007: 21.3 million prescriptions for propoxyphene medications were filled, making Darvocet one of the most prescribed generic drugs in the United States. Prescriptions for Darvon/propoxyphene alone (i.e. no acetaminophen, aspirin, caffeine, etc.) represented only 2.5% of the total prescriptins

2008: A Darvon and Darvocet lawsuit was filed against the FDA by Public Citizen because the regulatory agency never responded to their petition to remove the drugs from the market. The consumer group challenged the unreasonable delay, indicating that users were continuing to be exposed to a risk of problems from Darvocet and Darvon.

2008: Darvon and Darvocet side effects were involved in more than 15,000 emergency room admissions during the year, as users continued to take the medication without being informed about the risk of heart problems.

January 2009: FDA convened an advisory panel to review the efficacy and safety of Darvocet and Darvon. The panel of independent experts voted 14-12 in favor of pulling Darvocet and Darvon from the market due to the mounting number deaths associated with the drugs.

July 2009: Despite the recommendation of their advisory panel that Darvon and Darvocet be removed from the market, the FDA denied Public Citizen’s petition and allowed the medications to remain available.

The FDA did require the manufacturers to provide new warnings about the potential Darvon and Darvocet health risks and required the manufacturers to finally conduct studies to evaluate the potential risk of Darvon and Darvocet heart problems and the effect of propoxyphene on the heart.

August 2009: Public Citizen petitioned the FDA to reconsider the denial of their 2006 petition.

November 2009: Singapore’s Health Sciences Authority (HSA) requested suspension of propoxyphene sales

February 2010: New Zealand’s Ministry of Health released a statement that all propoxyphene-based pain killers would be removed from the market.

October 2010: Preliminary results from the Darvon and Darvocet heart study required by the FDA were submitted, finding that even when used as recommended, propoxyphene causes significant changes to the electrical activity of the heart in otherwise healthy volunteers. As a result the study was prematurely terminated when the results indicated an “unnecessary and significant risk of illness” as a result of abnormal heart rhythms from Darvocet, including death.

November 2010: The FDA announces that Darvon and Darvocet will be pulled from the market after the agency recommended withdrawing propoxyphene painkillers.

The decision to recall Darvocet, Darvon and generic equivalents came after the agency reviewed clinical data that suggests users are at a risk of potentially life-threatening heart problems from Darvocet and Darvon. When taken at approved doses, patients are at risk for cardiac toxicity, which can cause serious or potentially life-threatening Darvon and Darvocet heart rhythm problems.

The FDA finally concluded that the risks of heart problems from Darvocet and Darvon outweigh any benefits provided for pain relief at approved doses.


As a result of the manufacturers’ failure to investigate the link between Darocet and heart problems for decades, users who suffered a heart arrythmia, heart attack or sudden cardiac death while taking the medication may be entitled to financial compensation through a lawsuit.

New cases are no longer being accepted by Saiontz & Kirk, P.A. This page is maintained for informational purposes only.