#propoxyphene

Propoxyphene-based painkillers, of which the most well-known are Darvocet and Darvon but also include a slew of generics, have recently been banned by the Food and Drug Administration after over half a century on the United States pharmaceuticals market due to risks and side effects shown to be associated with the drugs. Thousands of lawsuits may be filed against the manufacturers of these products, which are marketed as painkillers for mild to moderate pain.

The ban was initiated on November 19, 2010, when Darvon and Darvocet’s parent company, Xanodyne, was asked by the Food and Drug Administration to stop selling these specific products after propoxyphene products were found in a study to alter the electrical activity of the heart. This phenomenon can occur even at low and standard doses, and can cause heart attacks, heart arrhythmia, and even sudden death. More than half a dozen minor producers of generic propoxyphene products were also forced to comply with the FDA’s ban.

In early January, there were fewer than ten Darvocet-related lawsuits in federal courts in the United States, but the number is expected to grow rapidly as public awareness increases about the facts of the drug and its side effects. It is estimated that thousands of heart symptoms have been caused to patients of the drug over propoxyphene’s 53-year career as a painkiller. The drug, which was banned in the United Kingdom in 2005, was also estimated to have caused between 1,000 to 2,000 deaths in the United States since its U.K. ban, despite the United States having been pushed by consumer advocacy groups to ban the drug for over 30 years.

Darvocet, a prescription treatment for mild to moderate pain, contains a combination of acetaminophen and propoxyphene, which is an addictive opiate pain-relieving drug that has the potential to cause an array of side effects. It is dangerous enough that it is sometimes used for the purpose of assisted suicide, and the risk of overdose is very real, especially in patients who are addicted to the drug.

People with a Darvocet addiction experience both mental and physical dependency on the drug, with withdrawal symptoms including anxiety, fatigue, cravings, nausea, paranoia, shakiness, and sweating. Darvocet addiction is similar to heroin addiction in the sense that as the drug continues to be taken, the body will build up a tolerance and dependency on the drug even if it is not being used for pain relief. Withdrawal from Darvocet can be just as dangerous as an overdose.

Darvocet addiction, like with all opiate addictions, has consequences that are severe and may lead to heart problems and even death. Because it contains acetaminophen, severe liver damage may occur in people who suffer from an addiction to the drug. Lifestyle consequences such as job loss and damaged relationships are also possible, as with any addiction.

Despite the November 2010 recall of propoxyphene products like Darvon and Darvocet by the Food and Drug Administration, the US Drug Watchdog believes that many consumers still aren’t aware of the serious risks associated with taking Darvon, Darvocet, and other generic propoxyphene products. Side effects of propoxyphene include changes to the electrical rhythms of the heart, which can cause heart attack and arrhythmia. Many patients have now been forced to use pacemakers or medication to control their heartbeats.

It is estimated that 22 million people in the United States alone have taken Darvon or Darvocet, with 10,000 of these patients developing one or more of the severe health issues that has been tied to the drug. Overdose and drug dependency are also serious risks associated with the medication, and a recent study has shown that even at standard therapeutic doses, propoxyphene can be extremely harmful.

Due to these risks and the suffering endured by many patients, Darvon- and Darvocet-related lawsuits are being filed all across the country. Patients who have experienced injury at the hands of a propoxyphene product may be entitled to compensation, based on costs incurred such as medical bills, lost wages, and pain and suffering. Families of people who have died are entitled to file a wrongful death lawsuit against the company, seeking compensation for their loss. However, in these cases, a statue of limitations may be in effect – usually from 1-3 years from the time of the patient’s death, a family must file their claim within this time period for it to be considered valid in court.

After 53 years of availability in the United States, painkillers Darvon (propoxyphene) and Darvocet (propoxyphene with acetaminophen) have been banned from distribution in the country. There has been much debate over the safety of the drugs, especially due to a toxicology study that found that a high number of deaths occurred in which the deceased had propoxyphene in their bloodstream.

Darvon and Darvocet are both narcotic pain relievers, which are recommended on a prescription basis to patients with mild to moderate pain. Darvocet, because it contains acetaminophen, is also used in cases where patients experience pain with a fever. Although propoxyphene is not an extremely strong painkiller, it has the potential for abuse and addiction.

More recent studies have found that the risks involved in taking these drugs include heart problems such as arrhythmia in otherwise healthy patients and even that the mortality rate of those taking propoxyphene is higher than that of those taking more powerful painkillers. Because of this, an advisory committee for the United States Food and Drug Administration voted to ban the drug in January 2009 – however, the ban was not announced officially until November 2010.

The US Drug Watchdog, a respected consumer advocacy organization, is alerting Americans to the dangers of Darvon and Darvocet and urging people to use the Internet to help spread word of the drugs’ potentially deadly side effects.

This group represents the pharmaceutical division of the organization known as America’s Watchdog. Weeks earlier they released a statement asking adults to post information to their Facebook, Twitter, and other social networking accounts in order to tell friends and followers to stop using prescription drugs Darvocet and Darvon. Both drugs include propoxyphene, a painkiller which has been proven to cause severe heart trouble, and that may also result in overdose or accidental death. The FDA issued a recall for both anti-pain medications in November 2010.

Making Public the Stories of Darvocet Dangers

It is important for everyone to help spread word of the recall, the advocacy group warns, because many of the 22 million US citizens who received prescriptions for Darvocet or Darvon have yet to hear of the FDA’s decision. Although this recall is one of the most significant of the past decade, it has not received coverage in proportion to its importance.

US Drug Watchdog fears that the recalled medicines may still linger in the cabinets of millions of Americans, and in fact millions more may still be taking Darvocet and Darvon to this day. The more common of the two drugs, Darvocet, consists of two painkillers: propoxyphene and acetaminophen.

Protecting Evidence for Darvocet Lawsuits

Though a majority of former Darvocet and Darvon users may think nothing of simply discarding the drugs, US Watchdog advises people to hold on to the containers. These may serve as valuable evidence for pending and possible Darvocet lawsuits against Xanodyne Phramaceuticals, Inc., a manufacturer of the drug.

US Drug Watchdog is a highly esteemed private pharmaceutical watchdog organization, and one of the most widely respected across the nation. For years it has been campaigning for transparency regarding the dangerous side effects of various prescription drugs, and now its spotlight is fixed on Darvocet. Its parent organization, America’s Watchdog, was nominated in 2002 for the American Trial Attorney’s Civil Justice Foundation Community Champion Award because of its tireless work to shield US citizens from injustice.

Darvon and Darvocet were approved by the FDA in 1957, and for years they have been under scrutiny as a result of the serious side effects they can produce in users. Yet it was not until early 2010 that the FDA reviewed data that proved propoxyphene’s tendency to interfere with the electrical activity of the heart. Following the review, the agency demanded that Xanodyne and generic manufacturers of the drug pull their products from the market.

Lawsuits Fueled by Darvocet Deaths

Although it has recently been pulled from the market due to serious health risks such as an increased risk of heart attack or heart arrhythmia in an otherwise healthy patient, the side effects of the mild painkiller Darvocet has been dismissed until recently by the Food and Drug Administration as not serious enough to warrant a ban on the product. The Drug Enforcement Administration rated Darvocet a Schedule IV drug, meaning it is less addictive than Schedule I, II, and III drugs and only more addictive than the lowest-ranking Schedule V drugs.

However, the DEA failed to take into consideration the fact that more potent Schedule II drugs such as Vicodin and Percocet have a lower mortality rate – these products kill only about 450 people a year from overdose, while the mortality rate with Darvocet and the similar propoxyphene-based Darvon is much higher. Consumer advocacy groups have been petitioning for around three decades to get the drug removed from the market in the United States, and propoxyphene products have been banned in Europe and the United Kingdom for several years. However, the Food and Drug Administration has only recently moved to ban the drug, putting countless lives at greater-than-necessary risk due to the delay in action.

In November 2010, Darvocet, Darvon, and all other painkillers containing propoxyphene were recalled by the FDA. The agency referred to data which links the drugs to an inappropriately high risk of contracting arrhythmia and other Darvocet heart problems.

Deadly Darvocet Side Effects Outweigh Drug’s Benefits

It had been known for years before the recall that Darvon (propoxyphene) and Darvocet (propoxyphene plus acetaminophen, the active ingredient in Tylenol) have the tendency to dangerously alter the heart’s electrical activity. In fact, the FDA published a report in 2009 that gave credence to these longstanding concerns.

Researchers conducting the study determined that even when administered in minimal doses, Darvon and Darvocet could still lead to negative inotropic effects. This means that the drugs can debilitate the strength of the heart’s muscular contractions.

Once the contractions of the heart have been weakened, the regular intervals of one’s heartbeat may shift dangerously. As illustrated in the image above, these shifts can mean a longer PR interval as well as a prolonged QT interval, and a widening of the QRS complex.

Shifts of this nature are considered symptoms of Darvocet heart arrhythmia, also known as irregular heartbeat. Individuals with this medical condition are at danger of sudden and sometimes fatal heart attack. Public Citizen, a consumer advocacy organization, had been putting pressure on the FDA for decades to ban Darvocet and Darvon. The group estimates that these two drugs alone were responsible for heart problems that resulted in death for approximately 1,000 to 2,000 Americans during the last five years alone.

Signs and Treatment of Darvocet Heart Arrhythmia

Some types of heart arrhythmia are actually harmless, while others can kill. Doctors can diagnose both types of arrhythmia by using an electrocardiogram (ECG).

Signs of dangerous Darvocet heart arrhythmia may include fatigue, dizziness, shortness of breath, or the feeling of fluttering or agitation of the heart. In some cases, the arrhythmia requires no treatment. For other cases, the arrhythmia can be ameliorated with anti-arrhythmia medications. The most severe types of arrhythmias need surgery to fix them.

Drugs that contain propoxyphene, such as Darvocet and Darvon, have recently been banned in the United States by the Food and Drug Administration due to the high risk of dangerous and life-threatening side effects that have affected many consumers. Side affects can include heart problems such as arrhythmia, accidental overdose, accidental death, and drug dependence.

In cases similar to this, with a high number of victims affected by the side effects of the drug, settlements can be very high and beneficial to plaintiffs. For example, the makers of the anti-inflammatory drug Vioxx which was withdrawn from the market due to a risk of heart attack ended up paying victims and families of victims $4.85 billion in damages in total.

Although it is still too soon to estimate the kind of settlement victims will receive in proceedings related to propoxyphene, but as prior patients are learning of the ban it is likely that many more will come forward with complaints of side effects related to the medication, including stroke and heart attack. Some victims of such side effects do not know of the connection to propoxyphene, but once lawsuits start being filed and media coverage increases consumers will become aware of the danger they have been put in.

Darvocet and Darvon have been used by millions of consumers for over half a century, and have been contested for the past three decades by consumer advocacy groups – however, the ban on the dangerous medication has come only recently. Although doctors agree that propoxyphene is not an extremely effective painkiller, and there are painkillers that work better and with fewer dangerous side effects, Darvocet and Darvon are among the 25 most commonly prescribed medications.

The Darvocet lawsuits have been consolidated into a multidistrict litigation case, meaning that no matter where a Darvocet-related lawsuit is filed, it will be assigned to the U.S. District Court for the Eastern District of New York to streamline the process and increase efficiency.