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Darvon pulled after 50 years

Need we say more about which side the FDA is on?  There were over 35 million scripts written for Darvon and Darvon with acetaminophen (Darvocet)in 2007.  Unfortunately the same occurs around the world.  It took to 2005 for the UK to pull the drug (one of the advantages of a managed health system).  But there is a major global assault by the industry and financial sectors to eliminate government intervention in business including the health system.  Slowly because of public sentiment, it is being dismantled in the developed world with the exception of the US where the legislation proposed had the guidance of the big PhARMA and insurance industries--jk. 



FDA experts to consider Darvon ban

FiercePharma, Jan 30. 2009, by Tracy Staton


Another set of pain pills faces possible extinction because of abuse: The FDA is asking an advisory committee to weigh in on whether to keep Darvon and Darvocet meds on the market.

Darvon (propoxyphene) was originally developed by Eli Lilly and has been on the market for more than half a century. Darvocet combines Darvon's active ingredient with acetaminophen. Both meds are sold as generics now, and more than 20 million scripts were written for products containing their API in 2007 {That proves how little the doctors know and how much PhARMA controls their information—jk}.

So what's the beef? Consumer watchdog Public Citizen petitioned the FDA to get the products banned, then sued when the agency didn't act. The lawsuit cited data implicating propoxyphene in 5.6 percent of the drug related deaths from 1981 to 1999. Plus, Public Citizen claims, the products are "relatively weak" painkillers, and they're toxic at only slightly more than the recommended dosage. U.K. health officials pulled the products in 2006 because of similar concerns, the Wall Street Journal reports.

FDA says it found 1,452 deaths associated with propoxyphene from 1957 through September 2008, but some of those reports listed more than one drug. Two of the generics makers selling the propoxyphene products--Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals--say they're safe and effective when used as directed, and they pointed out that more than 600 million scrips for the drugs have been dispensed over the past 50 years


Wall Street Journal | Health section, January 31, 2009, Jennifer dooren & Alica Mundy at


WASHINGTON -- A Food and Drug Administration panel recommended banning the painkiller Darvon and a related drug, following a decades-long effort by critics who charged that the drugs' users often intentionally or unintentionally overdose on them.

Darvon has been on the market since 1957, and Saturday marks the 30th anniversary of the first congressional hearing on its safety. Nonethless, it still enjoys wide use in treating mild to moderate pain. More than 20 million prescriptions were written in 2007 for products containing propoxyphene, the active ingredient in Darvon, according to the FDA.

The panel voted 14-to-12 that the drug's benefits didn't outweigh its risks, and called for removal from the U.S. market. The final decision is up to the FDA, which usually adopts panel recommendations but not always, especially when the vote is so close.

Darvon's defenders argue it is safe and effective when used as directed. The label warns against taking it in combination with alcohol or certain other drugs.

Darvon was developed by Eli Lilly & Co., which later combined propoxyphene with acetaminophen, the active ingredient in Tylenol, and sold that pill as Darvocet. Today the drugs are marketed by generic-drug makers.

Sidney Wolfe, a doctor at the advocacy group Public Citizen, has been fighting Darvon since the late 1970s, and triggered Friday's panel meeting with a petition and a lawsuit that sought to force the FDA to ban the drug.

In its petition, Public Citizen cited data from the Drug Abuse Warning Network implicating propoxyphene in 5.6% of drug-related deaths from 1981 to 1999. Public Citizen also said the network reported 2,110 accidental deaths related to propoxyphene over the same period.

The FDA also cited reports of serious events such as suicides, intentional and unintentional overdoses and heart attacks. But the agency's analysts said the evidence wasn't conclusive enough to ban Darvon.

In an interview about Darvon before Friday's meeting, Dr. Wolfe said, "Claims of its efficacy have been seriously undercut by the FDA's own analysis." He noted that the agency said Darvon "possesses weak analgesic effects."

In his presentation Friday, Dr. Wolfe presented updated data showing 503 deaths in 2007 in which propoxyphene was listed as a contributing factor. "All drugs have risks," Dr. Wolfe said. "If they don't have benefits they need to come off the market."



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32 years after Public Citizen first partitioned the FDA to pull the ineffective and dangerous Darvon, they finally did

From FiercePharma by Tracy Staton  November 22, 2010

After years of debate over their safety, FDA has moved to withdraw painkillers Darvon and Darvocet, plus the multitude of generic copycats. Why now? The agency says it received new data showing that propoxyphene, an active ingredient in both drugs, increases the risk of serious--even fatal--abnormal heart rhythms.

"These new heart data significantly alter propoxyphene's risk-benefit profile," the FDA's John Jenkins says in a statement. "The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks." 

Some would argue that the risk-benefit profile has been stacked too heavily on the risk side for years. Potentially addictive, the drug is also difficult to dose, because there's a fine line between an effective dose and a toxic one, the New York Times notes. The consumer watchdog Public Citizen started agitating for Darvon's demise back in 1978. Then, in 2005, the U.K. yanked propoxyphene drugs on worries about overdosing. Public Citizen followed up with another petition for withdrawal in 2006.

Last year, European regulators advised withdrawal; soon after, an FDA advisory panel recommended that the agency pull the drugs off the market, but the agency decided to put a boxed warning on them instead. At the time, FDA asked Darvon's maker, Xanodyne, to conduct a new study--and that's the study that unveiled the heart-rhythm troubles. The agency now is asking physicians to stop prescribing the drugs and recommends patients contact their doctors about alternatives.

- get the statement from FDA


FDA Statement at

Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne's decision and requested that they voluntarily remove their products as well.

The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits. 

"The FDA is pleased by Xanodyne's decision to voluntarily remove its products from the U.S. market," said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER). "These new heart data significantly alter propoxyphene's risk-benefit profile. The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."

The FDA is advising health care professionals to stop prescribing propoxyphene 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 management therapy.

Propoxyphene is an opioid used to treat mild to moderate pain. First approved by the FDA in 1957, propoxophene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).

Since 1978, the FDA has received two requests to remove propoxyphene from the market. Until now, the FDA had concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.

In January 2009, the FDA held an advisory committee meeting to address the efficacy and safety of propoxyphene. After considering the data submitted with the original drug applications for propoxyphene, as well as subsequent medical literature and postmarketing safety databases, the committee voted 14 to 12 against the continued marketing of propoxyphene products. In making this recommendation, the committee noted that additional information about the drug's cardiac effects would be relevant in weighing its risks and benefits.

In June 2009, the European Medicines Agency (EMEA) recommended that the marketing authorizations for propoxyphene be withdrawn across the European Union. A phased withdrawal of propoxyphene is underway.

In July 2009, the FDA decided to permit continued marketing, 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. In addition, the agency required Xanodyne to conduct a new safety study assessing unanswered questions about the effects of propoxyphene on the heart.

The agency now has reviewed the data from that study, which show 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, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.

"With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the heart," said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology, CDER. "However, long-time users of the drug need to know that these changes to the heart's electrical activity are not cumulative. Once patients stop taking propoxyphene, the risk will go away."

Xanodyne is based in Newport, Ky.