Manufacturer agrees to withdraw propoxyphene from the market

November 19, 2010

Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene (Darvon and Darvocet) from the US market at the request of FDA. FDA also has informed generic manufacturers of Xanodyne?s decision, and they will be removing their propoxyphene-containing products from the market as well.

Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene (Darvon and Darvocet) from the US market at the request of FDA. FDA also has informed generic manufacturers of Xanodyne’s decision, and they will be removing their propoxyphene-containing products from the market as well.

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, according to an FDA news release. As a result of this information, combined with other information, including new epidemiological data, the agency concluded that the risks connected with use of the medication outweigh the benefits.

FDA is advising healthcare professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their healthcare professionals as soon as possible to discuss switching to another pain management therapy.

Propoxyphene is an opioid used to treat mild-to-moderate pain. It was first approved by FDA in 1957.

“After 50+ years of propoxyphene availability in the United States, the voluntary withdrawal of Darvon and Darvocet by Xanodyne, and FDA’s recommendation that all generic manufacturers follow suit, represents a fairly significant event within the healthcare industry,” said David Calabrese, RPh, MPH, chief clinical officer, Med Metrics Health Partners, Worcester, Mass., and clinical editor of Formulary, Drug Topics' sister publication. “While the risk-benefit profile for these products has been a topic of great controversy for some time, these agents remain one of the top 100 most commonly prescribed drugs in the United States today, and their potential for full withdrawal from the market may have important clinical and economic implications for healthcare providers, payers and patients alike.”

Added Formulary Editorial Advisor Craig Coleman, PharmD, associate professor of pharmacy practice, University of Connecticut School of Pharmacy, Storrs, and director of the Pharmacoeconomics and Outcomes Study Group at Hartford Hospital, Hartford, Conn.: “Given the fact that drugs that prolong the mean QTc interval by >20 milliseconds are known to substantially increase the risk of Torsade de pointes, and that there are many oral pain killers available in the United States, the decision to withdraw propoxyphene from the market makes good sense.”

Since 1978, FDA has received 2 requests to remove propoxyphene from the market. Until now, FDA has concluded that the benefits of propoxyphene for pain relief at recommended doses outweighed the safety risks of the drug.