Popular painkiller linked to serious heart risk
The U.S. Food and Drug Administration (FDA) has announced that prescription pain medications Darvon and Darvocet are being withdrawn from the U.S. market. The popular painkillers have been linked to serious heart risks that may result in sudden death.
The move comes after the results of an FDA study in which new clinical data shows the drug, which goes by the generic name propoxyphene, puts patients at risk of potentially serious or even fatal heart rhythm abnormalities.
The FDA determined the new data shows the risks of the drug outweigh any benefits.
Darvocet, probably the most recognizable brand-name painkiller in this group, and Darvon are manufactured by Xanodyne Pharmaceuticals, Inc., which has voluntarily agreed to the product withdrawal. The FDA has informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision to remove its medications from the market and has requested they voluntarily remove their products as well.
The FDA is advising health care professionals to stop prescribing Darvocet, Darvon or generic propoxylene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain medication therapy.
Results of the recent FDA study show that even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death.
A wrongful death lawsuit has been filed against the makers of the newly banned painkiller Darvocet by a woman who claims the drug caused her mother to suffer a fatal heart attack. Peggy Oniate, individually and as a representative of the estate of her mother, Elizabeth Houlihan, filed the suit against Eli Lilly and Co., Xanodyne Pharmaceuticals Inc., Vintage Pharmaceuticals Inc., Qualitest Pharmaceuticals Inc., and Endo Pharmaceuticals in federal court in New Orleans. Houlihan reportedly began taking Darvocet or its generic version sometime in 2009 and continued to take the drug until her fatal heart attack in May 2010. The ... Read More
Another drug appears to be going down a similar path as the painkiller propoxyphene, known by the brand names Darvocet and Darvon, in the annals of banned drugs. Last week, German and French drug regulators banned the type 2 diabetes drug piogliazone (Actos) after reviewing data from a French study that suggested the drug put users at greater risk for bladder cancer. However, the Food and Drug Administration (FDA), as well as the European Medicines Agency (EMA) and Japanese drug authorities, opted to gather more data before deciding the fate of the drug. The FDA officially banned the popular prescription ... Read More
Another lawsuit has been filed against the makers of the painkiller Darvocet. Deborah M. Miller filed suit against Xanodyne Pharmaceuticals in federal court in New Orleans. Late last year the Food and Drug Administration (FDA) banned all drugs containing the propoxyphene after studies showed the drug put users at an increased risk for life-threatening heart rhythm abnormalities. Drugs that contain propoxyphene include the brands Darvocet and Darvon, as well as numerous generic equivalents. Propoxyphene was approved by the FDA more than 50 years ago and had become one of the most prescribed drugs in the country. It was previously banned in ... Read More
Before it was removed from the market late last year, Darvon, Darvocet and other painkillers containing propoxyphene were considered by some professionals as having caused more deaths annually than any other drug. It is listed by the U.S. Drug Enforcement Agency as one of the country’s top ten abused drugs, and was banned in the United Kingdom and Europe for years before the United States followed suit. At the time it was pulled from the U.S., an estimated 20 to 40 million prescriptions were written for the drug every year for the past 50 years. The bottom line – propoxyphene-containing ... Read More
A panel of federal judges has decided to hold off on a decision about whether to consolidate all federal Darvon and Darvocet lawsuits as part of a multidistrict litigation (MDL) until further arguments are heard at a hearing in July. The motion was filed just one month after all drugs containing propoxyphene, including the commonly prescribed Darvon and Darvocet, were pulled from the United States market because studies show the drugs put users at risk for potentially deadly heart rhythm abnormalities. Propoxyphene was approved by the Food and Drug Administration more than 50 years ago for the treatment of mild ... Read More
More lawsuits are being filed against Xanodyne Pharmaceuticals over the newly banned prescription painkiller Darvocet, from plaintiffs who claim they suffered bodily harm after taking the drug. Darvocet, which includes the active ingredient propoxyphene, was pulled from the United States market late last year after new studies showed the drug put users at risk for potentially fatal heart rhythm abnormalities. The latest lawsuit was filed by Deborah M. Rogers, individually and on behalf of others similarly situated, in federal court in New Orleans. The lawsuit accuses Xanodyne Pharmaceuticals of failing to warn users of the risks and side effects associated ... Read More
No decision will be made on whether to consolidate all Darvocet lawsuits filed in federal courts until at least July, the U.S. Judicial Panel on Multidistrict Legislation has decided, believing further arguments must be heard before a final decision is made on the matter. The motion to centralize the lawsuits under one judge as part of a multidistrict litigation (MDL) was originally filed in December 2010, less than a month after the Food and Drug Administration banned Darvocet, Darvon, and other propoxyphene-based generics. However, after listening to arguments in a March hearing, the judges on the MDL panel pushed back ... Read More
Online drug stores are still selling prescription drugs even though the medications have been deemed deadly by government agencies and banned from several countries including the United States. Drugs currently available on these sites include generic versions of the painkiller propoxyphene, known by the brand names Darvocet and Darvon, as well as generic versions of the weight loss medication sibutramine, known as Meridia. Propoxyphene was banned from the United States market by the Food and Drug Administration (FDA) late last year after studies showed that the painkiller put users at risk for dangerous heart rhythm abnormalities. Propoxyphene-containing drugs have been on ... Read More
It took decades for the Food and Drug Administration (FDA) to be swayed, but consumer watchdog group Public Citizen was at the helm of the movement to persuade the FDA to ban the prescription painkillers Darvocet and Darvon (propoxyphene) due to serious health risks. The FDA rejected both petitions submitted by Public Citizen over the years, but new studies that showed the drugs caused dangerous heart rhythm abnormalities finally convinced the federal agency that the risks associated with Darvocet and Darvon far outweighed the benefits. Now the watchdog group is taking aim at another medical product – latex medical gloves. ... Read More
An estimated 10 million people have used the painkiller propoxyphene, sold under the brand names Darvon and Darvoset by Xanodyne Pharmaceuticals, since 1957, when the medication was approved by the Food and Drug Administration (FDA). Potentially hundreds of thousands of people have been affected by the drug’s side effects, and many may not even be aware that their medical condition was caused by propoxyphene. Attorneys for Beasley Allen Law Firm are currently investigating cases of injuries and deaths caused by propoxyphene, and experts say the case against the pharmaceutical companies who supplied the drugs could grow as big, if not bigger, ... Read More