Darvon/Darvocet Finally Banned in the US

The FDA bans drug 6 years after the UK and 18 months after the European drug agency bans it.


Nov. 19, 2010 -- The FDA has at last banned Darvon, Darvocet, and other brand/generic drugs containing propoxyphene -- a safety-plagued painkiller from the 1950s.

New proof of heart side effects, in studies of healthy people taking normal doses of the drug, prompted the FDA to act.

An estimated 10 million Americans are taking Darvocet and other propoxyphene painkillers. They should NOT immediately stop taking the drugs, as there is danger of serious withdrawal symptoms.

Patients taking the drugs should instead immediately contact their doctors for help switching to different methods of pain control.

"Don't delay," warns Gerald Dal Pan, MD, MHS, director of the FDA's office of surveillance and epidemiology.

The FDA action comes nearly six years after the drug was banned in the U.K., and nearly a year and a half after the European drug agency banned it.

The public interest group Public Citizen petitioned the FDA to ban the drug in 1978 and again in 2006. The latter petition caused the FDA to take the matter to an expert advisory committee, which in July 2009 voted 14-12 to ban the drug.

But the FDA overruled the panel, instead asking Darvon/Darvocet maker Xanodyne Pharmaceuticals Inc. to conduct studies of the drug's effects on the heart. The results of those studies led to the FDA ban.

"The drug puts patients at risk of abnormal or even fatal heart rhythm abnormalities," John Jenkins, MD, director of the FDA's office of new drugs at the Center for Drug Evaluation and Research, said at a news conference. "Combined with prior safety data, this altered our risk assessment."

The FDA ban comes too late for Public Citizen, which blasted the FDA for waiting far too long to protect the public.

"Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since the time the U.K. ban was announced," Sidney Wolfe, director of Public Citizen's health research group, says in a news release.

Wolfe says Public Citizen will call for a congressional investigation into who at the FDA "was responsible for the loss of so many lives in this country."

Jenkins says although it's impossible to know exactly how many deaths are linked to propoxyphene, an FDA study shows that more deaths are linked to the drug than to either of two alternative opioid painkillers, tramadol and hydrocodone.

Dal Pan says that people who have taken Darvocet, Darvon, or other propoxyphene drugs for a long time are not at increased risk of heart problems.

"Long-term users should not worry: The heart effects are not cumulative," he says. "Once people stop using propoxyphene, the side effects should go away."

More information about the propoxyphene ban is available on the FDA web site -- including, for the first time, a video news release.


I was prescribed the drug for roughly five years and after it taking 50 years for them to decide it was too dangerous, my confidence in their statement "people who have taken Darvocet, Darvon, or other propoxyphene drugs for a long time are not at increased risk of heart problems." is not very high. Every now and then, I can actually feel still my heart skip a beat so yes, I am a bit concerned.

"Long-term users should not worry: The heart effects are not cumulative," he says. "Once people stop using propoxyphene, the side effects should go away."

"Should"? In other words, they don't really know.

 

Knowing in advance that it's been banned in other countries, why have you continued to take it?

+ If you're taking yourself off of it, make sure you wean easily into a substitute.

 

Unfortunately, every public policy decision made by the US government is made by corporations and special interest groups whose money lines the pockets of politicians and government agencies. The reason Darvon and Darvocet weren't banned sooner here is probably due to Big Pharma's huge influence on our government. Same reason that rBgH-laced milk is banned in other countries but not here; Monsanto owns a huge chunk of our government and contributes huge sums to several Senators' and Representatives' campaigns.

Darvocet didn't work for me the one time I took it. Sorry Gangrenous, hope the palpatitations go away.

 

I didn't know that it was banned in other countries. It's not something drug manufactures really mention to doctors or pharmacies so they in turn don't inform their patients.

+ I was switched to vicodin by my doctor back in January.

Thanks a_g.

 

Eek. I took this stuff daily for several months for back problems a couple years ago. I had no idea it was banned in the UK or under scrutiny of any kind. Fortunately I never had any side effects from it.

-sj loves kevin spacey

 

I'm glad the anti-depressants I take aren't in line to be banned in the United States, or I'd be a real mess.

For all the talk about Big Phrama people like to throw around, there are some people that just need to be doped up on certain meds, and I am one of them.

 

Actually, what it means is that in most cases any side effects will go away, excluding those rare cases where it interacted poorly with a pre-existing condition (genetic or otherwise). That's typically the case with most drug side effects.

Still, you could be eligible for damages if you're in that small sub-group.

 

Big Pharma makes some useful products, but they should not be in the pocketbooks of the very agents that test and approve the safety of those products. Conflict of interest, and it's all over the US government.