Health

Xanodyne Recalls Darvocet & Darvon: Arrythmia Risk

by Jordan Yerman | November 19, 2010 at 10:23 am

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Propoxyphene: Darvon & Darvocet Pulled From Market

Xanodyne Pharmaceuticals has voluntarily recalled its Darvon and Darvocet painkillers. The FDA is also advising the manufacturers of generic meds containing propoxyphene to do the same.

Clinical trials suggest that propoxyphene, primarily sold as Darvon and Darvocet, can cause dangerous heart arrythmias (irregular heartbeats).

Darvon first hit the market in 1957. More recently, Xanodyne mixed propoxyphene and acetaminophen, selling the new product as Darvocet.

Safety concerns have dogged propxyphene for years. The FDA recieved two advisory committee requests to remove Darvon and Darvocet from the market, but those requests were not followed, though a new study was ordered.

The results of the study: propoxyphene caused heart arrythmias in users of the drug, even if they had healthy hearts to begin with.

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.

Darvon, which contains the active ingredient propoxyphene, has been on the U.S. market for more than 50 years and was developed by Eli Lilly & Co.

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Banks, M (not verified)

at 22:17 on November 19th, 2010

If darvocet has been recalled...do you know of any drugs for pain that would be closely related to the darvocet that would help with fibromyalgia, excluding cymbalta. Darvocet has been used by different friends and family for years. I use it for fibromyalgia pain and do not want any drug that would make me sleepy or drugged so that I can carry on my daily routine and not be afraid of those side effects. I really hate that darvocet has been taken off the market because it helped me so much. I understand the reason of the recall. I would love to hear your comments on the recall and also on drugs work as darvocet did.

S.M.C (not verified)

at 21:56 on November 21st, 2010

I have been on Darvocet for years! Only thing to help my Fibro. also. I don't understand why the recall. There are a LOT of pain medicines with far more serious side effects that Darvocet.It's been on the market for years!!! Can't you see the lawsuits after all that time?? Have no idea what I will do. Have tried other drugs and this is the only one that I can take.