Darvocet and Darvon voluntarily removed from the market
Today, the US Food and Drug Administration announces its recommendation that the [poorly effective] opioid pain reliever, propoxyphene, (Darvocet/Darvon) be removed from the market.
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 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.
In January 2009, after a Citizen Petition (to remove propoxyphene from the market) was delivered to the FDA, an FDA advisory board voted 14 to 12 to remove propoxyphene from the market. In July 2009, the FDA announced that stronger overdose warnings are needed in conjunction with leaflets given to patients at each dispensing. At this time, the FDA concluded that the pain relief benefits of propoxyphene outweighed the risks of the medication.
However, to more fully establish the risks associated with propoxyphene (especially in overdoses), the FDA mandated that Xanodyne (manufacturer of trade name Darvocet/Darvon) perform QT safety studies investigating the effect of propoxyphene on cardiac electrophysiology at increasing doses. In 2 internal FDA memos, (1 and 2), a preliminary study is reported to show increased risk for cardiac arrhythmias (prolonged PR interval, prolonged QT interval, and QRS complex widening) even when using the medication at maximally recommended doses (600 mg daily). Due to these results,
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.”
Goodbye propoxyphene – you won’t be missed. Except by the patients who will be queuing up to ask us why…