Darvocet Recall Came Too Late For a Generation

The company that manufacturers Darvon and Darvocet (which also contains acetaminophen), Xanodyne Pharmaceuticals, Inc., has agreed to comply with the FDA’s demands, and generic makers of the drug are expected to do the same. At the time the market withdrawal request was issued, an estimated 10 million patients nationwide were taking a pain medication containing propoxyphene. It is likely that hundreds, if not thousands, of Darvocet lawsuits will be filed against not only Xanodyne, but other manufacturers of the drug. Xanodyne Pharmaceuticals, the manufacturer of the name-brand versions of Darvon and Darvocet, has opposed consolidation of the litigation, arguing that much of the evidence and discovery in the cases will focus on the individual health of each plaintiff. In addition, the company points out that many of the cases involve generic versions of Darvocet or Darvon, which is available from a number of different drug makers.

Darvocet, the Deadly Painkiller

On November 19, 2010 Xanodyne Pharmaceuticals Inc. the manufacturers of Darvon and Darvocet, the brand name version of the prescription pain medication propoxyphene, agreed to recall the medicine from the US market at the request of the FDA. The FDA sought the removal of propoxyphene after receiving new data showing that the medicine puts individuals at a higher risk of possibly extreme or even fatal heart rhythm, one of the many deadly side effects of Darcovet. The FDA is notifying health care professionals to discontinue prescribing propoxyphene to their patients, and patients who are currently using the medication to get in touch with their health care professional as soon as possible to talk about switching to a different pain management treatment.

Darvocet Death Affects 22-Year-Old

One of many Darvocet lawsuits filed in state and federal courts was that of Tammy and John Gilbert of Ohio, who unfortunately lost their daughter to the once-popular painkiller in 2009 after she was prescribed the drug for a torn ligament in her knee. At the time, Darvocet was a routinely prescribed medication for mild to moderate pain, and the list of risks associated with the medication that came on the prescription bottle and in an insert with the drug reassured the Gilberts that the drug would be safe. However, this was not the case.
Kara Nicole Gilbert, a 22-year-old with no family or personal history of heart problems, was found dead in her apartment eight days after starting the medication, of acute cardiac failure with evidence of pulmonary edema. Her parents have filed a wrongful Darvocet death lawsuit against Xanodyne Pharmaceuticals, the makers of the medication, in hopes of receiving compensation for the suffering they have endured after the loss of their only child. Although there is nothing that will bring their daughter back to life, a settlement will help with medical bills and other costs associated with the loss.
Kara Gilbert’s death was particularly tragic since Darvocet and other propoxyphene-based painkillers have been under investigation for decades due to the observed potential for fatality and other side effects associated with their use. The medication was banned in 2005 in the United Kingdom, and consumer advocacy groups began petitioning the United States’ Food and Drug Administration for a recall as early as the 1970s. However, regulations have been in place that prevent the Food and Drug Administration from requiring the monitoring of drugs once they are approved for the pharmaceuticals market. However, what the FDA was able to do was ask Xanodyne to conduct a study on their product – after which the company initiated a voluntary recall of Darvocet, having determined that the risks of the medication far outweigh any benefits to consumers.

Darvon and the Heart

Darvocet heart arrhythmia is the common name by which people reference the most serious of Darvon side effects. It is also referred to as irregular heartbeat. Over 850,000 Americans are hospitalized each year for irregular heartbeat of some type.
Pharmaceutical drugs normally come with a list of potential side effects. And Darvon was not an exception to the rule. The list of potential side effects listed for Darvon use upon its release included: nausea, general weakness, lightheadedness, abdominal pain, skin rashes, minor visual disturbance, euphoria, hallucinations, headache, dysphoria, constipation, vomiting, sedation and dizziness.

Even more side effects after Darvocet's release

And just as most pharmaceutical drugs come with a list of potential side effects upon their release…most pharmaceutical drugs’ list of potential side effects increase drastically “after release.” The extended list of potential side effects associated with Darvon and Darvocet after their release to the public included: stomach disorders, kidney disorders, lowered blood pressure, liver disorders, rash and itch, psychiatric disorders, nervous system disorders, disorders of metabolism and nutrition, elevated heart rate, confusional state, immune system disorders such as hypersensitivity, symptoms of drug withdrawal, heart and respiratory arrest (cardiac arrest), respiratory arrest, drug dependence, heart attack, coma, dizziness, vomiting, convulsion, eye disorders, heart rhythm disorders, diarrhea, accidental death, accidental and intentional overdose and suicide.
Propoxyphene is the active ingredient in Darvon and Darvocet. Evidence from independent studies has indicated that the propoxyphene can interfere with the electrical activity of the heart; even when the heart is otherwise healthy. The interference with the electrical activity of the heart can result in heart arrhythmia, heart rate abnormalities, irregular heart rates and other cardiac related issues that can cause fatality through heart attack. Estimated Darvocet related deaths are in the thousands according to experts in the field.
Darvocet and all related drugs were pulled by the FDA after 53 years in use in the US market as a common, mild painkiller. The eventual recall came after the FDA reevaluated the seriousness of the Darvon/Darvocet side effects.

Darvon Side Effects Lead to Recall

Plaintiffs across the country have been filing lawsuits related to Darvon and Darvocet, popular propoxyphene-based painkillers that were pulled from the market in the United States in November of 2010 after more than half a century in circulation. The recall came after studies found that Darvon, Darvocet, and other propoxyphene products can cause heart problems and accidental death in patients, even at standard prescribed doses.
As one of the most popular painkillers on the market, and intended for mild to moderate pain, propoxyphene products have been prescribed to millions of patients since their introduction to the market in 1953. Since then, thousands may have been affected by the adverse side effects of the medication – experts estimate that Darvocet side effects have led to the accidental deaths of some 2,500 people in the United States alone, and its high lethality lends another use to the drug – as an assistant to suicide.
Although the Food and Drug Administration first received a petition for a ban of the drug due to its serious side effects in 1978, an advisory board did not vote for a ban until 2009 – and it was not carried out until late 2010, putting countless lives at risk by delaying the verdict and allowing more prescriptions to go into circulation. Since side effects of Darvon and Darvocet are coming under public scrutiny more recently, patients across the United States have filed lawsuits related to the drug, hoping to receive some form of compensation for the side effects they have suffered and the costs incurred due to medical treatment and missed wages.
Because Darvocet and Darvon have been on the market for over half a century, and the FDA’s ban is relatively recent, it is not yet known how many people were affected by the side effects – there have been claims that 5% of drug related deaths in a 10-year period have been related to Darvon and Darvocet.

Darvocet Death: Suicides and Accidental Overdoses

Cornelius Kellehar died on November 2, 2010 of sudden heart problems, three months after he was prescribed Darvon and Darvocet for undisclosed health reasons. Darvon and Darvocet are both propoxyphene-based medications used in the treatment of mild to moderate pain, and before they were banned in late 2010 were among the most widely prescribed medications in the United States. The Food and Drug Administration approved propoxyphene products for use in 1957, and they have consistently been among the most popular painkillers since.
However, Kellehar’s case is not the only one like it. Darvon and Darvocet have been linked to thousands of accidental overdoses, and since ten million people were prescribed a propoxyphene product in the year 2009 alone, the risk has been very real and very high for many people. Although consumer advocacy groups have been petitioning for a ban on the drug since 1978, the Food and Drug Administration did not take action against the product until late last year. The drug has been banned in the United Kingdom since 2005 and Europe since 2009.
Experts estimate that in the five years between the United Kingdom’s propoxyphene ban and its ban in the United States as many as 2,000 people could have died as a result of complications from taking Darvon and Darvocet. This number climbs to 10,000 when we take into account who have taken propoxyphene drugs since their introduction in the 1950s. And Darvocet is known to be deadly – propoxyphene is one of the most common medications used in assisted suicides and doctor-assisted euthanasia.
However, Cornelius Kellehar, not unlike thousands of other victims of accidental deaths related to Darvon and Darvocet, did not intend to end his life. His widow, Mary Ann Kellehar, has hired a lawyer and is seeking compensation for a wrongful death that never should have been allowed to happen.

Class Action Lawsuit Filed Against Xanodyne Pharmaceuticals Inc

Given the situation below, what would you do?
You have taken a drug that was supposed to relieve your pain. It contains a mix of a narcotic pain reliever and acetaminophen. You did your research on those components, so you thought you knew the risks going in. However, after taking the drug, you begin to suffer from arrhythmia and heart attacks.
What Would You Do?
File a class action lawsuit. At least, that’s what Linda Gallagher of New Orleans did. According to her, Xanodyne Pharmaceuticals Inc., knowingly and willingly put the lives of millions of people at risk with Darvocet. All for a profit.
It turns out that she has a very solid case on her hands. In November, the FDA finished a study that found that even recommended doses of Darvocet could cause dangerous heart electrical changes that may lead to arrhythmia and Darvocet-induced heart attack.
What’s more is that Europe had been warning about these Darvocet related side effects for years.
If this class action lawsuit were to become successful, those involved could receive not only compensatory damages, but also punitive damages. A substantial payout indeed. The courts would do this in order to show pharmaceutical companies that they do not take kindly to the type of negligent behavior that Xanodyne has taken part in.
What Should You Do?
So, you are a user of Darvocet and the drug has affected you. The question is no longer “what would you do,” but “what should you do?” The best course of action would be to hop on the lawsuit against the makers of Darvocet by speaking to a Darvocet lawyer. It might be your chance at a huge Darvocet settlement, and some peace of mind.

Darvon Death: The Worst of the Side Effects

Although less publicized and formerly less prescribed than Darvocet, the similar drug Darvon is also included in the Food and Drug Administration’s recall of propoxyphene products. The only difference between the two is that Darvocet contains acetaminophen, which is the active ingredient and fever reducer in Tylenol, whereas Darvon is pure propoxyphene. Both mild painkillers put patients at risk for the same set of severe side effects.
Darvon was widely prescribed to the American public to treat mild to moderate pain before it was banned by the Food and Drug Administration in 2010, after more than 30 years of consumer advocacy groups petitioning for its ban. The FDA decided that the risks involved in taking the drug far outweighed the painkilling benefits it offered. Although propoxyphene products were banned in the United Kingdom in 2005 and in Europe in 2009, the United States decided to wait until even more lives were put on the line before taking steps to ban the drug – it is estimated that just since the United Kingdom propoxyphene ban, between 1,000 and 2,000 American propoxyphene patients have died as a direct result of taking the drug, deaths that simply did not need to happen.
The FDA ban of propoxyphene came after a study showed that, even at standard therapeutic doses of the drug, accidental death was a serious risk – even just one or two pills can alter the electrical rhythm of the heart, leading to side effects that can be fatal such as heart attack or arrhythmia. Darvon was also known as an insufficiently effective painkiller with a serious risk of drug addiction or dependency attacked to it. Although thankfully the risk of developing a Darvon side effect is reduced as soon as the drug leaves the system, millions of people have already been negatively affected by the drug.

Food and Drug Administration Bans Darvon and Darvocet

Darvon and Darvocet brand and generic drugs containing propoxyphene were banned today by the Food and Drug Administration in the US because of serious safety concerns. The UK banned the drugs previously in 2005.
Serious heart-related Darvocet side effects have been demonstrated in healthy people taking these drugs. It is estimated that over ten million Americans take Darvon, Darvocet and other compounds containing prophoxyphene. Propoxyphene-based drugs are analgesics in the opioid category, used to relieve mild to moderate pain and are additionally an anti-tussive and local anesthetic.

Doctors Recommend Against Quick Darvocet Withdrawal

Because of the possible danger of acute withdrawal symptoms, many doctors warn patients not to suddenly stop taking the drug, preferably weaning away from it gradually. Dr. Gerald Dal Pan, MD, MHS, director of the FDA office of surveillance and epidemiology says that patients in the United States should return to their doctors to find different pain relief medications.

Public Citizen, a public interest group, had attempted to have the drug banned in 1978 and again in 2006. Ultimately the FDA took the matter to an advisory committee of their experts who voted 14-12 to ban darvocet; but rather than banning the drug outright they chose to do more studies of the drug’s effect on the heart. In the end, the results of these studies led to the ban.

Risk for potentially critical (or even fatal) heart rhythm abnormalities with Darvocet

John Jenkins, MD is the director of FDA’s office of new drugs. He says that propoxyphene-based drugs put patients at risk of potentially serious or even fatal heart rhythm abnormalities. Public Citizen condemns the FDA, saying that the ban comes too late. They say that if the drug had been banned sooner, at least 2,000 more people not have died. Dr. Jenkins is not so sure; he asserts that it’s not that easy to determine exactly how many people have died because of the darvocet side effects.
However according to Dr. Del Pan, the effectives of the drug are not cumulative. “In other words, the side effects of darvon and darvocet will wear off if you stop taking the drug."
Make sure you keep checking back here, as this story has not yet been fully told. There’s sure to be more information yet to be revealed.

Darvocet is Very Addictive and Very Dangerous

Propoxyphene is an addictive opiate pain reliever that is one of the main ingredients in Darvocet, a prescription medication for mild-to-moderate pain relief. The Food and Drug Administration has recently recommended its ban from United States prescription drug markets in part due to its potential for addiction.
Like many opiate narcotics, such as heroin, addiction to propoxyphene is dangerous because the body gets used to the drug over time, and more and more of the drug is needed to prevent withdrawal symptoms and achieve the desired effect. Withdrawal symptoms from propoxyphene, which are similarly dangerous to its overdose symptoms, include anxiety, fatigue, cravings, sweating, nausea, and paranoia, and affect the user both physically and mentally.
Patients who take Darvocet over time are likely to become addicted to it, more so in some cases than with other more powerful pain relievers. Although propoxyphene is only used for mild to moderate pain relief, the consequences are addiction are extremely serious and may affect a user to the point at which he or she can no longer function in his or her everyday life.
Because Darvocet contains acetaminophen, a fever reducer, there is a possibility of severe and possibly permanent liver damage associated with addiction and long-term use of Darvocet. The side effects of Darvocet addiction are so severe and the possibility of death so real that the drug is sometimes used in assisted suicide and is referred to as a “Darvon cocktail” in these cases.

Darvocet -- A Drug of Choice for Suicides

Studies have shown that there have been a disproportionate number of suicides and intentional overdoses linked to propoxyphene-based prescription medications Darvon and Darvocet. The risks for these cases go up in patients who have been taking sedatives or have a history of emotional disturbance.
The Food and Drug administration has recently requested the makers of Darvon and Darvocet to cease production of the drug, as well as requesting makers of generic propoxyphene products to pull their products off of the market, due to these risk factors as well as others including accidental Darvocet overdose, risk of drug dependency, heart problems, and convulsions.
At least twenty percent of all Darvon and Darvocet-related deaths in 2007 were reported by the Drug Abuse Warning Network to be suicides, although only about one-third of the population was taken into account for this report – the actual number of deaths may be much higher.
Although propoxyphene products have been banned for years in Europe and the United Kingdom, it is only recently that they have been taken off the US market, with the Food and Drug Administration citing patient suicides as one of the reasons for the ban.

Severe Heart Troubles Trigger Darvocet Recall

Darvocet and Darvon, both manufactured by Xanodyne Pharmaceuticals, Inc., were, until recently, two of the most commonly prescribed drugs in the United States. In late November 2010, the FDA mandated a recall for these drugs, saying that the serious risk of developing Darvocet heart problems as a consequence outweighed any benefits.
Both medications contain propoxyphene, which has been used as a treatment for mild or moderate pain following surgery. Now Xanodyne, as well as all generic makers of the drugs, have been forced to withdraw those medicines from the market.

U.K. Recalled Same Drugs more than Six Years Ago

Darvocet, Darvon, and all other drugs containing propoxyphene were banned in the U.K. in 2004. Yet they continued to be prescribed and consumed in the United States until late last year. Darvocet is quite similar to Darvon; it differs in that includes acetaminophen, the active ingredient in Tylenol.
In February 2009, an advisory panel to the FDA recommended an immediate Darvon and Darvocet recall. The panel found that both drugs carried a substantial risk of suicide or overdose that far outbalanced any pain relief they brought about. The FDA, however, declined to recall the medications, and instead applied a “black box warning” to the drugs’ labels. These black box warnings, which advise caution and describe the dangerous side effects, are the most forceful measures the FDA can take, short of a recall.

Previous Requests to Discontinue Darvocet

Since 1978, the FDA has received two different petitions seeking the recall of Darvocet and Darvon. In late 2010, Public Citizen, a consumer rights organization, filed a lawsuit against the FDA because they believe the agency broke the law when it neglected to act on a 2006 petition. The petition in question asked that Darvocet, Darvon, and all generic forms that contain propoxyphene be removed from the market due to a tendency to become physically addictive. More than 2,000 accidental Darvocet deaths have been attributed to these medications, and it has been determined that they do not offer substantially greater pain relief than other, safer prescription painkillers.

Darvocet Settlements: How it is Good for Everyone Involved

It has been just two months since the drug Darvocet was pulled out of the US and Canadian markets after a massive recall. Since then, Xanodyne, the makers of the drug, have had many suits filed against them in court. Even though that is true, no settlements have been paid out yet. This may be stalling from Xanodyne, since if they settle, they would be losing quite a bit of money. Drug settlements can take years, but in this case it will probably be in everyone’s best interest to settle.

Settling Will Save Xanodyne Money

In early 2010, a man from Alabama won $25 million from a pharmaceutical manufacturer called Roche. He took them to court over the drug Accutane, claiming that they misrepresented the side effects of the drug. He was initially only looking for $2.6 million, but after the jury sided with him unanimously, he ended up winning $25 million.
Xanodyne should look at this case and realize that if they settle, they may actually save a lot of money, because if they lose their cases, then they will be in the hole for potentially billions of dollars.

Settling Will Save the Plaintiffs Time

Drug lawsuits can take years and years to reach any sort of conclusion or settlement, but the cases that have been put against Xanodyne are only a few months old at best. If a Darvocet settlement is reached soon, Xanodyne, and those filing suits against them, may be able to save years of hassle.

Darvocet Lawsuits So Far

Only a few cases against Xanodyne have been made public so far. One case was filed by a woman named Linda Gallagher. She filed a case after suffering a Darvocet heart attack. Her case is the first case filed against Xanodyne in federal court since the drug Darvocet was recalled.
Another case is from Kristin Esposito from New York. She suffered from a heart arrhythmia while taking Darvocet, and is seeking $10 million in damages to cover lost earnings and medical bills.

It only took 53 Years to ban Darvocet

Darvon, Darvocet, and other propoxyphene products have been on the pharmaceuticals market in the United States for 53 years, and have been contested for more than half that long – in 1978 the consumer advocacy group Public Citizen petitioned the Food and Drug Administration to initiate a recall of the drug, and the same group repeated its petition in 2006. Although propoxyphene products have already been banned for several years in the United Kingdom and in Europe and a Food and Drug Administration recommended a ban in January of 2009, the FDA has only recently voted to ban propoxyphene from the United States market and protect consumers from some severe Darvocet side effects.
Side effects of Darvocet include heart problems such as arrhythmia and heart attack, as well as the potential for drug addiction, suicide, and accidental Darvocet overdose. Dr. Sidney M. Wolfe of Public Citizen estimates that thousands of propoxyphene patients have been killed by the drug since only 2006, the last time the FDA was petitioned to ban the medication. The Food and Drug Administration, however, maintains that the evidence that propoxyphene can cause heart problems even in otherwise healthy patients comes only recently and in the last period of testing that was done on the product. The risks to the heart come even to patients who are taking the recommended dose, especially if they are elderly.
Doctors across the world agree that there are more effective painkillers than Darvocet and other propoxyphene products, and most of these come with much lower risk of serious harm to the patient. However, since the Food and Drug Administration has waited over three decades from the first petition to finally ban the drug, they have put thousands and even possibly hundreds of thousands of propoxyphene patients at risk of suffering from one or more of the many serious Darvocet side effects.

Darvocet Banned after 30 Years

Although it has been banned in the United Kingdom for five years and the European Union for one, the United States have only recently moved to ban the painkillers Darvon and Darvocet, both propoxyphene products which have been shown to cause heart problems and even death in some patients. Darvocet, which contains both propoxyphene and acetaminophen, is used to control mild to moderate pain and sometimes fever, while Darvon – which is simply propoxyphene – is used only for pain relief.
Although the effect of the drug is not as strong as that of some other prescription painkillers, studies have shown that the risks to patients taking propoxyphene products is greater than that of those who are taking some varieties of stronger prescription painkillers. Studies have observed that people who are taking propoxyphene products have an increased risk of Darvocet heart arrhythmia, even if they are otherwise healthy. In addition, there have been a disproportionate number of deaths recorded in people who have been found to have propoxyphene in their system. Due to these possible complications during treatment for an ailment, an advisory panel for the Food and Drug Administration voted in January of 2009 to ban the drug; however, the ban was not announced publicly until November 2010.
Debate over the safety of these drugs has been going on for over 30 years, with the consumer advocacy organization Public Citizen first petitioning the Food and Drug Administration for a ban of the drug in 1978 and then again in 2006. The European Union’s ban on propoxyphene products, ironically enough, stemmed from a study conducted in the United States that demonstrated the disproportionate number of Darvocet deaths that had occurred.
More recent studies, however, have made the argument against using these products more compelling by demonstrating the risk to consumers – individuals who had taken the drugs were seen to suffer from electrical changes in the heart such as arrhythmia and there were more drug-related deaths in which propoxyphene was found in the bloodstream than evidence of other, more powerful painkillers.
Although it is only about half as potent as codeine, it has the potential to be habit-forming and therefore dangerous to some consumers. The manufacturers of these products have agreed to comply with the recommendation of the Food and Drug Administration that the product be banned.

Darvocet Kills and We Have the Proof

Darvocet, Darvon, and other similar generic painkillers which use the opioid propoxyphene have caused the accidental deaths of nearly 2,000 people in the United States alone since 2005. Propoxyphene has been found by the FDA to alter the electrical activity inside the heart and increase risk for things such as arrhythmia, Darvocet heart attack, and sudden death, even at recommended doses!
The drug was recalled in November of 2010, but why didn’t the FDA act sooner?

A Darvocet Victim

John Matuszak was an NFL legend, and a very healthy individual. As a Raiders defensive lineman, the types of workouts that he was put through should have left him at the peak of physical health, but sadly, in 1989 his life was cut short by heart failure.
How could someone so fit die so early? Darvocet. The lineman passed away due to acute propoxyphene intoxication. This story is an all too real reminder that Darvocet can affect anyone at any time. In Florida alone, 395 deaths were reported to be caused by propoxyphene between 2005 and 2009.

Darvocet Has Some Survivors

Kristine Esposito was one of 22 million people who were taking Darvocet for minor pains. Even though she is still alive today, Darvocet did not spare her. Soon after she was prescribed the drug for stomach pain in February of 2010, she began to feel uncomfortable pains in her chest. She was rushed into surgery and learned that she was the victim of a severe case of Darvocet heart arrhythmia.
Because of the damage done to her heart by Darvocet, Kristine was forced to undergo two very invasive procedures: electrical cardioversion, and cardiac ablation, in order to try and reverse the effects of Darvocet.
Doctors say that she is lucky to be alive, but will unfortunately die prematurely due to the trauma her heart muscle has been put through.

Fighting Back Against Darvocet

Kristine Esposito is taking her case to court, and is seeking 10 million in damages against Darvocet and Xanodyne, to help her pay for the damages caused by the drug.
Darvocet side effects are a real risk to anyone who has taken the drug, and more and more people are filing lawsuits against Darvocet every day. Hopefully the drug that has taken the lives of many will be put away forever.