FDA Advisers: Ban Painkiller Darvon

Fda Ban Panel Recommends Withdrawing Drug That's Been On The Market For 50 Years.

by Associated Press

Published: Sat, January 31, 2009 - 1:46 pm CST Last Updated: Sat, January 31, 2009 - 1:48 pm CST

(AP) Government advisers are recommending a ban on Darvon, a painkiller that's been around for 50 years.

A Food and Drug Administration advisory panel voted 14-12 Friday to recommend withdrawing Darvon after a hearing on its risks and benefits. The drug was first approved in 1957, when there were few alternatives for pain except aspirin and powerful narcotics.

Now mainly marketed as Darvocet, which includes a dose of acetaminophen, the drug remains one of the top 25 most commonly prescribed medications. More than 20 million prescriptions were written in 2007.

The consumer group Public Citizen said the FDA should withdraw Darvon because the drug offers weak pain relief and poses an overdose risk, with the potential to be used in suicides.

"It has unique risks and no unique advantages," said Dr. Sidney Wolfe, a drug safety expert with Public Citizen who first sought a ban in the 1970s. "It has been a big drug of abuse for quite a long time."

Two companies that market the drug - Xanodyne Pharmaceuticals and Qualitest/Vintage Pharmaceuticals say the medication is safe and effective when used as directed. In documents filed with the FDA, the companies say doctors need a range of options to treat pain, and note that many other painkillers have become drugs of abuse.

Dr. Jerry Avorn, a professor of medicine at Harvard and a critic of the pharmaceutical industry, is glad the FDA is taking a hard look at Darvon.

"I have been astonished at how widely used this drug is," Avorn said before the advisory panel vote. "It's no longer the most abusable and most dangerous drug in its class, but the fact that there are worse drugs doesn't make Darvon a good drug."

It has unique risks and no unique advantages. who first sought a ban in the 1970s. It has been a big drug of abuse for quite a long time.

Dr. Sidney Wolfe, Public Citizen The United Kingdom banned its version of Darvon in 2005. The FDA, however, may take a more cautious approach, such as requiring stiffer warnings, safety studies or special education efforts aimed at doctors and patients.

In an analysis prepared for the hearing, the FDA's safety office said it had searched the agency's database of reported drug problems, but the result was "insufficient" to allow reviewers to make a clear-cut recommendation. The safety office found more than 3,000 reports of serious problems. The top three were suicide, drug dependence and overdoses.

In a separate analysis, the FDA office that handles painkillers said Darvon is a weak pain reliever. Most studies show that in Darvocet, the widely used combination drug, the Darvon component appears to contribute "little or no" additional pain relief beyond that provided by the acetaminophen component, reviewers said.

Wolfe presented the advisory panel with new data from the government's Drug Abuse Warning Network, which tracks emergency room visits and deaths. It showed that Darvon-related deaths rose to 503 in 2007, from 446 in 2006. In both years, about 20 percent were suicides. The network covers only about one-third of the U.S. population.

Data from the Florida's medical examiner reporting system showed that in 2007 Darvon was present in the bodies of 341 people who died from drug-related causes. Medical examiners identified it as the cause of death in 85 of the cases, or 25 percent.

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mustuknow Says:

Sat, Jan 31, 2009 at 7:27 pm

It just hacks me off to no end that the abusers have caused the headaches for those who actually need help. Again, the lady I was referring to has more than anyone should be taking and our tax dollars are paying for them and then she turns around and sells them to others for $8 and $10 a piece and she pockets the money. To me she is part of the problem, just one of many that are out there making things hard for the doctors and the patients.

rosepetal Says:

Sat, Jan 31, 2009 at 6:57 pm

mustuknow, i agree. i figured i must have taken your post wrong. sorry about your father, i have heard that kind of back pain is awful.

BamaBob Says:

Sat, Jan 31, 2009 at 5:50 pm

I’ve had a lot of this stuff over the years. It seemed to help me, or maybe it just made me not care about the pain. Hmmmmmm…...

mustuknow Says:

Sat, Jan 31, 2009 at 5:41 pm

I perfectly agree. I was not saying that people who are legitimately in pain don’t have to go through he!! to get their meds, please forgive me if that is the way it sounded. My father ruptured a disc in his back and could not even get up and down by himself and when he walked even to the bathroom someone had to hold him up. The doctor prescribed him EXACTLY the amount of meds he needed until his surgery but they did not do that until after his MRI came back conclusive of the problem. He hurt for 3 days waiting on the MRI. I PERFECTLY AGREE people who are in chronic pain have to go through entirely too much BS to try and get some relief.

The drug heads I was referring to is those who take narcotics for recreational purposes. Please forgive me for sounding so callous it was not meant to those who actually need it.

Last note, I know of a girl who has sickle cell anemia and lives better than most of us. She gets 180 Lortab 10 every month and sells most of them… ie Drug head

rosepetal Says:

Sat, Jan 31, 2009 at 5:08 pm

what drug heads? some people are really in pain. do you know what the people who are really in pain have to go thru to get pain medicine. its a lot more complicated than a 30 minute drive. the illegal use of drugs is making it hard on everyone.

mustuknow Says:

Sat, Jan 31, 2009 at 4:00 pm

LOL it took 57 years to figure out that Darvocet is just glorified Tylenol that you have to pay a lot more for. Doctors are coming under more and more pressure to no prescribe narcotics to patients because of the abuse of prescription pain meds by drug heads. The sad part is those of us who do not abuse and sell these drugs are the ones who suffer. My son has many allergies and we have several meds he has to take on a daily basis but when he needs a decongestant I have to drive 30 miles to a pharmacy to get a bottle of Sudafed because all of the red tape our local pharmicies will not carry it, it is not worth the hassle for them for what little money they make off of it. I personally think it is a shame that the drug heads can get bottles after bottles of meds no questions asked but the average working joe has to give his life history just to get medicine when we are sick.