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FDA Pulls Darvon Darvocet From Market

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Washington, DCXanodyne Pharmaceuticals Inc, which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the US market at the request of the US Food and Drug Administration (FDA).

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."



Posted by

Darvocet was not a problem for me. I had taken it for years with no side effects. My pain from the back was controlled, but after it was withdrawn, I was miserable because I cannot take NSAIDS, due to ulcers and colon problems. I was given a prescription for Tramadol and in some states it is in the league of narcotics, but it is okay for patients to take it" even you are having so many side effects."! Why leave these meds. on the market and take off one that is effective to many people. Was the study taken with people that smoked or just "lets take this one off the market, because people can't become addicted to it!" Tramadol has many side effects and some are very severe and can become addictive, but I have not heard the FDA say any thing about Norco,Loratab,and Vicodin which they all contain acetaminophen

Posted by

Why would the FDA allow anybody the option to take medicines like Propoxyphene when they knew the risks way back when?
I took Propoxyphene beginning in 2005 and I found out about it's risks in 2009 via LawyersandSettlements, not from my doctor(s). I asked my doctor to be taken off the drug when I heard about it.
Now I wonder if some doctors might say bad eating habits, smoking or just being stressed was the reason for a failing heart, not considering it might be the Darvocet we take?
We count on the above mentioned to keep us abreast on what's going on with the medicines we take. Now that's scary.

Posted by

I have been taking Darvocet and it has helped me in many ways of coping w/my pain. I always took it as it was needed & never had any problems,and I believe that when pain is there it shouldn't be pulled away from people that is getting day by day. I have arthritis, fybromygia & herniated disc in my neck & back. the Darvocet didn't take the pain completely away but it helped me cope through out the day. now I am prescribed tramadol & it has already made me ill & still feeling pain. Please let me know what I am suppose do and probably others in my situation as well.

Posted by

SO, over 30 or 40 years after this drug was known for being the (back in the 1970"s) as the number one cause of Od's in DA WHOLE NATION (look it up in your ancient almancac) they have finally decided to do what every half-wit knew when every detox doctor in the nation was writing for that stuff by the barrell full. Makes one wonder what other deadly goodies are being handed out by the car load that will be be recalled soon or actually not soon but after they have made millions in profit.

Posted by

This is scary because I was on darvocet for a long time. I did end up in the hospital for several days for my heart. Maybe this is the reason why????

Posted by

What else can a patient take for pain


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