Our Law Firm (and I) Named to the Darvocet MDL Plaintiffs' Leadership

The Propoxyphene Multi District Litigation (MDL) is based in Kentucky and was recently established. The United States District Court Judge recently issued an  Order Appointing Counsel to Leadership Positions and the Court accepted our application.

You may read the Order here (PDF). 

December 7, 2010 Darvocet Legal Recall News and Updates

Some folks are asking why did it take 30 years to pull Darvocet/Darvon off the market? As Dr. Sidney Wolfe, a drug expert at Public Citizen in Washington, D.C.,has said to many reporters: "Propoxyphene has been one of the top 50-selling drugs for at least 40 years," and its sales have generated huge profits for drug companies. Yet its dangers have been well known for most of that time.

Estimates are that several thousand people died as a result of taking the drug, countless others developed serious medical problems, and millions wasted money on an expensive painkiller that didn't work.
Over the years, many experts called for the removal of propoxyphene, but those calls were routinely ignored. Public Citizen petitioned the FDA to ban the drug in 1978 and again in 2006; finally, the group sued the FDA in 2008.

Six years ago, the drug was banned in the United Kingdom based on data that it didn't work and, at doses only slightly above those often prescribed, leads to accidental overdoses. 

In 2004, British health authorities ordered a phased withdrawal of the drug, known in the U.K. as co-proxamol. It was withdrawn gradually rather than immediately because the narcotic has addictive properties and patients require adequate time to switch to other painkillers.

From the BBC in 2004: A popular painkiller is being withdrawn from the UK market over concerns about links with suicide. Co-proxamol, used by thousands for conditions such as back pain, will be phased out over the next year or two. Data showed fatal overdoses due to co-proxamol are the second most frequent means of suicide with prescribed drugs in England and Wales, accounting for up to 400 deaths each year.The risk of death associated with co-proxamol overdose seems to be higher than for either tricyclic antidepressants or paracetamol. http://news.bbc.co.uk/2/hi/health/4221829.stm

 

According to British health authorities, the drug was banned because “each year there are 300- 400 fatalities following deliberate or accidental drug overdose involving propoxyphene/acetaminophen in England and Wales alone. Approximately one-fifth [60-80] of these deaths are considered to be accidental.” The British government further stated that the drug’s effectiveness “is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.... It has not been possible to identify any patient group in whom the risk-benefit [ratio] may be positive.”  http://healthfully.org/dnd/id8.html

Finally in 2008 the UK banned it outright. Interestingly, the UK's role seemed to be to reduce suicides, as opposed to concerns about heart conditions. 

Read more here: http://blogs.wsj.com/health/2010/11/24/without-darvon-and-darvocet-whats-a-pain-sufferer-to-do/

Read more: http://www.sacbee.com/2010/12/05/3229146/pain-drug-propoxyphene-should.html#ixzz17PgVpHLH

Read more: http://www.sacbee.com/2010/12/05/3229146/pain-drug-propoxyphene-should.html#ixzz17Pg2ZvtN

12/1/10 Darvocet Legal: FDA Drug Safety Podcast for Healthcare Professionals: FDA recommends against the continued use of propoxyphen

Good stuff in this transcript from the FDA's podcast:

Welcome, my name is Mary Kremzner, a pharmacist in the Division of Drug Information. On November 19, 2010, the Food and Drug Administration issued a Drug Safety Communication recommending against continued prescribing and use of the pain reliever propoxyphene because new data show that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA has requested that companies voluntarily withdraw propoxyphene from the United States market.
Propoxyphene is an opioid pain reliever used to treat mild to moderate pain. It is sold under various names as a single-ingredient product, for example Darvon, and as part of a combination product with acetaminophen, named Darvocet.


FDA's recommendation is based on all available data including data from a new study that evaluated the effects that increasing doses of propoxyphene have on the heart. The results of the new 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, which can be seen on an electrocardiogram, or EKG, can increase the risk for serious abnormal heart rhythms. FDA has concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses.

In July 2009, FDA announced an ongoing safety review of propoxyphene, which included evaluating its potential effects on the heart.


Following receipt of a Citizen Petition requesting the withdrawal of propoxyphene-containing products from the United States market, FDA convened an Advisory Committee meeting on January 30, 2009. After presentations by FDA, the petitioner, and the company reviewing the efficacy and safety data from the propoxyphene drug applications, the literature and postmarketing safety databases, the committee voted by a narrow margin of 14-to-12 against the continued marketing of propoxyphene products. Those who voted for propoxyphene to remain on the market advised requiring improved labeling, particularly with warnings about use in elderly patients and about use with concomitant opioids or alcohol. Finally, there was general agreement that additional information about the cardiac effects of propoxyphene would be relevant in further weighing the risk and benefit. As a result, under new authorities given to FDA by the Food and Drug Administration Amendments Act, the agency required the drug manufacturer to conduct a thorough QT study to formally evaluate the effects of propoxyphene on cardiac electrophysiology. In order to determine a safe supratherapeutic dose to incorporate into the Thorough QT study, FDA required the drug manufacturer to first conduct a multiple-ascending dose study or MAD.

The MAD study was a randomized, double-blind, placebo-controlled sequential multiple-ascending dose study of propoxyphene for 11 days. The study was conducted in healthy volunteers. The first cohort of study subjects was dosed with a total daily dose of 600 mg of propoxyphene (the maximum labeled dose) and the second cohort was dosed with a total daily dose of 900 mg. Additional doses were planned, however the study was placed on clinical hold due to safety concerns. Study subjects were monitored with telemetry and intermittent EKG recordings, comparable to the monitoring that would occur during a Thorough QT study.

The drug manufacturer has submitted to FDA the results from the 600 mg and 900 mg cohorts.
Significant QTc interval prolongations were observed with the propoxyphene 600 mg and 900 mg dose levels. With the 600 mg daily dose, at steady state on Treatment Day 11, the largest mean change of QTc was 29.8 milliseconds, which occurred 7 hours after the last dose; with the 900 mg dose the largest mean change was 38.2 milliseconds, which occurred 2 hours after the last dose. It is recognized in the International Conference on Harmonisation, or ICH, E14 Guideline1 that drugs that prolong the mean QT/QTc interval by >20 milliseconds have a substantially increased likelihood of being proarrhythmic. In addition, a dose-dependent prolongation of PR and QRS intervals was observed in the study.
Because the elderly and patients with renal insufficiency have a reduction in the clearance of propoxyphene and its cardioactive metabolite, norpropoxyphene, through the kidneys, these populations can be especially susceptible to proarrhythmic effects of the drug.
At this time, FDA recommends that Healthcare Professionals:

1. Stop prescribing and dispensing propoxyphene-containing products to patients.
2. Contact patients currently taking propoxyphene-containing products and ask them to discontinue the drug.
3. Inform patients of the risks associated with propoxyphene.
4. Discuss alternative pain management strategies other than propoxyphene with your patients.
5. Be aware of the possible risk of cardiac conduction abnormalities, for example prolonged QT, PR, and QRS intervals, in patients taking propoxyphene and assess patients for these events if they present with any signs or symptoms of arrhythmia.
6. Report any side effects with propoxyphene to FDA's MedWatch program at www.fda.gov/medwatch.

Darvon and Darvocet/Propoxyphene News November 19, 2010

The FDA  has asked that propoxyphene, (brand names Darvon and Darvocet, Xanodyne Pharmaceuticals) be removed from the US market. The decision will also affect generic manufacturers and the makers of propoxyphene-containing products.

The FDA has told medical professionals to stop prescribing propoxyphene. Patients who are taking the stated medications should not sinply stop taking it, ut should contact their doctor soon as possible to discuss switching to another pain-management therapy.

Propoxyphene is an opioid typically used to treat mild to moderate pain. It was first approved by the FDA in 1957. It is sold by prescription under various names alone or in combination with acetaminophen. Since 1978, the FDA has received two requests to remove propoxyphene from the market.

In January 2009, an FDA advisory committee voted 14 to 12 against the continued marketing of propoxyphene products. At that time, the committee called for additional information about the drug's cardiac effects.

Talk to us if you believe that you or a loved one was injured because of this medication. The call is confidential and free.

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