The popular pain relievers with the active
ingredient of propxyphene have been voluntarily withdrawn. The most
utilized formulation is with acetaminophen and was abbreviated on our
prescription labels like so; PROPOX-N/APAP 100-650
Please read the FDA release below and contact one of
our pharmacists if we can answer any further questions.
FDA NEWS RELEASE (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234350.htm)
For Immediate Release: Nov. 19, 2010
Media Inquiries: Karen Riley, 301-796-4674,
karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
Xanodyne agrees to withdraw propoxyphene from the U.S. 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 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.