Xanodyne agrees to withdraw propoxyphene from the U.S. market

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http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234350.htm

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 , 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. "

My personal comment is;

I find it VERY hard to believe that a drug that's been around for more than 50

years is more dangerous than the newer still under patent drugs. This drug has

been around for so long we know more about it than the newer drugs.