FDA Says Xanodyne Agrees To Withdraw Propoxyphene From U.S. Market

WSJ ^ | 11-19-10 | STAFF

[Mikey_1962]

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.

[Mikey_1962]

At one time Darvon Compound 65 made by Eli Lilly was the #1 prescription pain reliever in the world.

In an odd twist the racemic version of propoxyphene Novrad (Darvon spelled as the mirror image) was taken off the market more than 30 years ago.

[Dr. Bogus Pachysandra]

Also, Yoyodyne is removing Imipolex G from the market.

[Condor51]

Its funny, but the 'pain killer' Darvocet (N 100) gives me migraines. I haven't been able to take it since approx 1978. That's the only opiate 'pain killer' drug I have a reaction to (I'm 'allergic' to it). So the Orthopedic Doc I was seeing then switched me to Tylenol #3, which worked fine. Except Tylenol #3 causes constipation.

Thank goodness they came out with Vicodin, Vicodin ES, and Norco. Norco works best for me. It has 2½ mg's more of the opiate than Vicodin ES and a lot less acetaminophen, which is easier on the liver. And, there's no constipation with Norco. (and Vic 'ES' is the size of a Horse Pill)

[Mikey_1962]

If you tolerate Vicodin (Hydrocodone) then Oxycodone (Percocet) should work well too. But Hydrocodone is Schedule III whereas Oxycodone is Schedule II so Oxycodone is more controlled.

[Dr. Bogus Pachysandra]

Codeine for me please. The last time I had a bad cough, my Doc gave me syrup with Hydrocodone. I was unable to sleep! I seems the pharma company had added another ingredient to combat the drowsiness caused by the codeine. I am extremely vulnerable to these added “uppers.” The first, and last, time I took pseudfed(sp?), 30 years ago, I was up for more than two days. And that, of course, made me much sicker! Constipation caused by codeine? Prunes or figs are preferable to sleepless nights.

[Condor51]

*** If you tolerate Vicodin (Hydrocodone) then Oxycodone (Percocet) should work well too. But Hydrocodone is Schedule III whereas Oxycodone is Schedule II so Oxycodone is more controlled. ***

Oxycodone is wierd for me. My Doc and I agreed to try that once instead of Norco and I didn't like it. I wasn't buzzed or anything but I felt just kind of dazed and mentally slowed down. And the pain relief was somewhat less than with Norco.

So on my next visit I explained that he said it was prolly because of the pill's dosage being too low and with Oxycodone it's kind of 'trial and error' until you get the right dose for your body size.

But with my chronic pain, taking time for 'trial and error' isn't an option. So we went back to Norco and all's been fine since then. My pain is managed₍₁₎, there's no buzz, no liver problems, and no side effects.

(1) The pain is always there, it's just at a degree I can tolerate. And *sometimes* ignore when I'm deeply involved in something, like photography or playing my guitar.

[Mikey_1962]

Condolences on your chronic pain.

Chronic pain management is trial and error for two reasons:

1)Pain is perceived and therefore subjective (not really objectively quantifiable).

2) Treating chronic pain with opiates is politically charged and several physicians have been dealt with sternly by the DEA for trying to do it.