Darvocet Side Effects Increased Risk Of Cardiac Disorders. The US Food & Drug Administration’s (FDA) Darvocet recall was due to the drug’s association with dangerous and sometimes fatal heart rhythm problems. Developed decades ago, the side effects of Darvocet the prescription painkiller, has been the subject of safety concerns for years, yet it was only in 2010 that the US Food & Drug Administration (FDA) and the manufacturer of Darvocet took steps to protect patients from this dangerous medication. Lawyers at Parker, Waichman, LLP specializing in defective drug litigation are investigating potential Darvocet lawsuits on behalf of anyone who suffered from Darvocet side effects, in particular heart injury while using this drug.
Our Darvocet lawyers are currently offering free case evaluations to victims suffering as a result of Darvocet side effects. If you or someone you love was injured by Darvocet, you may be entitled to compensation for medical bills, lost wages, pain and suffering, and other damages. We urge you to contact a Darvocet lawyer at our firm today to protect your legal rights and learn about the side effects of Darvon that are the subject in Darvocet settlement which is predicted to be in the billions by experts.
Darvocet Side Effects
Darvocet is a combination of propoxyphene and acetaminophen. It was originally developed by Eli Lilly & Co., but is now marketed by Xanodyne Pharmaceuticals. Propoxyphene, an opioid used to treat mild to moderate pain, was used by 10 million people in 2009, according to the FDA. Most of those patients received Darvocet.
In 2006, the consumer advocacy group Public Citizen asked the FDA to ban Darvocet, as well as Darvon (propoxyphene alone), saying they had been associated with serious Darvon and Darvocet side effects, including even the deaths of at least 2,110 people between 1981 and 1999. Dr. Sidney Wolfe, the group’s director, also asserted that propoxyphene was a relatively weak painkiller and posed an unacceptable toxic risk to the millions of patients prescribed it each year.
In January 2009, an FDA advisory panel narrowly voted 14-12 to recommend that the FDA remove Darvon and similar products from the market. Rather than heed the advice of its advisory panel, the FDA decided to permit continued marketing of Darvocet, (despite reported Darvocet side effects) and other propoxyphene products, but required that a new boxed warning be added to the drug label alerting patients and health care professionals to the risk of a fatal overdose. While the new warning did not include mention of heart rhythm problems, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.
Ultimately, that study found that even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, known side effects of Darvocet, including sudden death. In a memo posted on the FDA’s website, the agency said it is not possible to monitor for or mitigate the risk of a fatal cardiac arrhythmia that might occur at the recommended dose of propoxyphene. The study’s findings prompted the FDA to ask that Darvocet, along with Darvon, be withdrawn from the market in 2010, due to these potential Darvon and Darvocet side effects. The FDA also said it was asking the manufacturers of generic propoxyphene-containing products to remove those products from the market.
In calling for withdrawal of the drug contained in Darvocet and linked to the severe side effects of Darvocet, the FDA urged doctors to stop prescribing it immediately. But it advised patients to continue taking propoxyphene while consulting quickly with physicians to arrange for alternative medication.
At the time of the Darvon and Darvocet recall many questioned why it had taken the FDA to act so long to act to protect patients from drugs like Darvocet and Darvocet side effects especially since there are many safer painkillers available. Dr. Sidney Wolf, who had called for a Darvocet ban in 2006, blasted the FDA’s action as too late and called for congressional hearings into why the agency took so long to act.
Legal Help for Victims of Darvocet Side Effects
If you or a loved one were injured by Darvocet or experienced severe Darvocet side effects, you may have valuable legal rights, and be eligible to file a Darvocet N 100 lawsuit. By filing a Darvocet lawsuit, you could receive compensation if a Darvocet settlement is agreed on. To discuss your Darvocet lawsuit case with a qualified Darvocet lawyer, please fill out our online form, or call 1-800-YOURLAWYER (1-80-968-7529) today.
Injured by adverse side effects of Darvocet?
Public Citizen’s Health Research Group asked the FDA on February 28, 2006 to issue a Darvon and Darvocet recall of the two popular painkillers. Among side effects of Darvocet and Darvon, the painkillers are alleged to have caused the deaths of at least 2,110 people between 1981 and 1999. Additionally, Public Citizen’s Health Research Group said several hundred more people have died accidentally after taking the drugs each year since then. Dr. Sidney Wolfe, the group’s director, said the main active ingredient in the drugs, propoxyphene, is a relatively weak painkiller and poses an unacceptable toxic risk to the millions of patients prescribed it each year. It’s been sold since 1957. The drug’s popularity has waned, but still doctors wrote 23 million prescriptions for propoxyphene-containing drugs last year. Darvocet, which combines propoxyphene with acetaminophen, is among the best known of these types of painkillers.
An analysis of 26 studies that compared propoxyphene and acetaminophen with just acetaminophen or a dummy pill found the “narcotic combination offered little benefit over acetaminophen alone” in treating pain. “Thus, propoxyphene provides minimal if any additional analgesia to acetaminophen alone and is associated with significant adverse effects. It cannot be recommended for routine use,” Dr. Carolyn Sachs of the University of California, Los Angeles, wrote in her analysis, published in March 2005 in American Family Physician.
Co-proxamol, Britain’s most frequently used drug, has been taken off the market due to concerns about the high risk of accidental death from slight overdose and its frequent use in suicides. Co-proxamol is prescribed to hundreds of thousands of people every year has been the subject of a staggered withdrawal because of evidence that it can cause death if patients exceed the maximum recommended dosage by as little as two tablets. As many as 400 deaths a year are linked to either accidental or intentional overdoses of co-proxamol.
A recent study found that the medication, whose effects are increased by alcohol, was responsible for 18 percent of all drug-related deaths and 5 percent of all suicides. As late 1997, it was the second most prescribed drug after the antibiotic amoxycilin. It is currently marketed by several pharmaceutical companies as co-proxamol and it is also sold under the brand names Distalgesic, Cosalgesic and Dolgesic. In the United States the drug is sold under the names Darvocet and Darvon.