Darvon Side Effects

Darvon side effects of heart rhythm problems and possible heart failure have resulted in a Darvon recall in the US and attorneys are filing Darvon lawsuits on behalf of injured victims across the nation.

At the request of the FDA, Xanodyne Pharmaceuticals, the manufacturing company responsible for producing the pain medication Darvon, has removed Darvon from the U.S. market. This FDA action was taken in response to new clinical data and epidemiological studies which indicate that Darvon puts patients at risk of serious and potentially fatal heart rhythm abnormalities. After evaluating Darvon side effect information, the FDA determined that the potential risks of Darvon use outweigh the possible pain-relieving benefits of the drug, and issued a Darvon recall. Darvon (propoxyphene) is an opioid which was approved by the FDA in 1957 and has since been used in the treatment of mild to moderate pain. Before the Darvon recall, Darvon was typically prescribed after dental surgery, including the extraction of wisdom teeth, and was manufactured by Xanodyne Pharmaceuticals. The FDA has also informed generic manufacturers of propoxyphene-containing products like Darvon and Darvocet (a brand-name drug made by Xanodyne containing propoxyphene in combination with acetaminophen) of Xanodyne's decision to pull Darvon from the market, requesting that they voluntarily remove their products as well. If you or a loved one has suffered from a Darvon side effect, contact a Darvon attorney to discuss the benefits of filing a Darvon lawsuit against Xanodyne.

Darvon Heart Rhythm Side Effects

The Darvon recall includes several propoxyphene-containing drugs, including Darvon, Darvocet A500, Darvocet-N, Darvocet-N 100, and Darvocet-N 50. The most significant source of Darvon side effect information was a safety study conducted by Xanodyne which was intended to address unanswered questions about the effects of Darvon on the heart. This Darvon side effect study showed that Darvon causes changes in the heart's electrical activity, which can increase the risk of serious abnormal heart rhythms that have been linked to significant adverse effects, including death. This data also indicated that the risk of Darvon side effects for any patient is subject to change based on even small changes in the patient's health status, including dehydration, a change in medications, or decreased kidney function. With new information regarding Darvon side effects, the FDA for the first time has data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart. The main side effect of Darvon use, which led to the Darvon recall, is the potential for the drug to cause severe and potentially fatal heart rhythm abnormalities among patients.

Darvon Recall

New information about the harmful side effects of the pain reliever Darvon has led to a nationwide Darvon recall. Due to the severity of these Darvon side effects, the FDA advised healthcare professionals in 2010 to stop prescribing Darvon to patients, and urged patients taking Darvon to consult their physicians to discuss alternative treatment options for pain management. The results of Darvon clinical trials, which prompted the FDA to issue the Darvon recall, suggested that Darvon use can cause heart-related side effects like:

  • Slowed heartbeat
  • Interruption of the heart's transmission of electrical impulses
  • Decreased ability of the heart to contract properly

These Darvon side effects are extremely dangerous and can lead to fatal complications for Darvon users. Although the FDA has instituted a Darvon recall, it is possible that patients may continue to take Darvon, unaware of the potential for the drug to cause life-threatening heart-related side effects.

Since 1978, the FDA has received two requests to pull Darvon from the market, both of which were denied due to the FDA's conclusion that the benefits of Darvon for pain relief at recommended doses outweighed the potential safety risks of the drug. In January 2009, the European Medicines Agency recommended that marketing authorizations for propoxyphene-containing products like Darvon be withdrawn across the European Union. Later that year, the FDA decided to permit continued marketing of Darvon but required Xanodyne Pharmaceuticals to add a new boxed warning to the drug label regarding the risk of a fatal overdose. The FDA also required Xanodyne to perform a new safety study assessing potential adverse effects of Darvon on the heart. After reviewing the data from this Darvon safety study, which indicates that even at recommended doses Darvon causes significant changes to the electrical activity of the heart, the FDA concluded that the potential risks of Darvon outweigh the possible benefits of the drug, leading to a Darvon recall.

Darvon Attorneys for Heart Side Effects

The heart-related side effects associated with Darvon are extremely dangerous and may even lead to death. For individuals affected by the pain medication Darvon, legal help is available. If you or a loved one has suffered from a Darvon side effect, contact a Darvon attorney to discuss the benefits of filing a Darvon lawsuit against Xanodyne Pharmaceuticals. Drug companies like Xanodyne are responsible for the safety of their medications and should be held liable for any adverse side effects sustained by consumers of their products, especially if the drug is recalled due to dangerous side effects. Unfortunately, some pharmaceutical companies intentionally conceal the side effects of their drugs and then deny liability for dangerous drug-related injuries. This deceptive practice puts millions of consumers at risk of suffering serious injury and even death without their knowledge. You are not at fault for serious injuries resulting from the proper use of a dangerous drug. With the help of an experienced Darvon lawyer, victims of Darvon side effects can file a Darvon lawsuit against Xanodyne and collect the financial compensation they deserve.

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