FDA Advisers: Ban Painkiller Darvon

(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."

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.

[rwsmith29456]

How about let the doctors and their patients decide? If enough are willing to replace it with something better and cheaper, it will die a death of its own without any action required from the FDA.

[mrsh0150-2009]

I hope the FDA leaves Darvon alone. I am a 59 year old woman. I have Fibromyalgia and additional back pain. Straight Darvon works for me and helps me get through my pain. I use it on an as needed basis. Sometimes it pays to go back to some of the old time drugs to find something that works. Darvocet does not work for me. I have no clue why. Normally Tylenol doesn''t work for me either. I prefer Ibuprophen. I am not a drug abuser. 20 mil rx''s is alot of people using this drug. If there are that many scripts being written then why would someone say this drug is not selling? Also, if it is ''weak pain relief'', why does it work on this many people? Thank you for your time and consideration in reading what I have to say.

[baileyccc]

Let''s look at Profits for Big Pharma. The world patent for Darvon has long expired and the genetics have taken over. Very little profit and no incentive for a Doctor to write a prescription for Darvon. This makes the FDA look like they are doing a good job while they are really suspending a drug that doesn''t sell. They think they are getting good PR, if the truth was known, Darvon manufactures probably ask for this to be done.

[nevminer735]

Be carfull FDA your messing with a durg that has an ingredient that the drug adict Rush Limburger can substitute for OXYCOTIN if neccessary.

[reallymecbs]

Follow the money...
If this medicine is removed from the market, the 20 million prescriptions per year that are written for it will have to be written for something else. No doubt something newer and considerably more expensive.

[Meg003]

Tincup356

That''s just my point-I do know. It''s not so shocking that people keep it a big secret. People who want to smoke pot, and many do, are smoking it. They grown their own, or they buy it from the Mexicans.

It''s just not a habit that everyone will choose. You can smell it on people. It gets in their sofas, and on their clothes. It''s not that bad, but it''s not a smell I want on my fabrics. And smoking is allowed in few public places.
The res

[tincup356]

Oh, come on. Marijuana may not be any more evil than tobacco, but it is still a lung irritant and not healthy. Most public places ban smoking, which would include marijuana. And the majority of nonsmokers are not going to take up a smelly, nasty habit like smoking marijuana in preference to having a glass of wine with a meal.

There would not be a huge new wave of smokers created out there, when smoking is becoming associated with a low-class lifestyle. But possibly we would keep more of the dope-smokers'''' money in the U.S. instead of sending it to Mexico. For that reason alone, it might be worth legalizing pot.

Posted by Meg001 at 06:23 PM : Jan 31, 2009................You just might be surprised how many would come out of the closet so to speak.......some that would flat even surprise you as you might of thought of them as fine outstanding citizens of the community you live in......some of them might be in your family....you just dont know.

[Meg003]

Tincup356

Oh, come on. Marijuana may not be any more evil than tobacco, but it is still a lung irritant and not healthy. Most public places ban smoking, which would include marijuana. And the majority of nonsmokers are not going to take up a smelly, nasty habit like smoking marijuana in preference to having a glass of wine with a meal.

There would not be a huge new wave of smokers created out there, when smoking is becoming associated with a low-class lifestyle. But possibly we would keep more of the dope-smokers'' money in the U.S. instead of sending it to Mexico. For that reason alone, it might be worth legalizing pot.

[tincup356]

Strange how they put a story about Obama''s half brother being arrested for possession of marijuana,,,but no blog for it? I wonder how obama will feel having his brother in jail....for possessing natural.Obama is not listening to the people....A change .org survey of what Americans wanted to see done ....legalize marijuana was by far...the number one choice of the people....wonder why? Because it is not the demon drug that the feds would want you to think...in fact if it were legalized , it would create MILLIONS of new JOBS, and BILLIONS of REVENUE...Isn''t that something that ALL Americans are worried about right now? New industries would not just be for recreational purposes...The oil and hemp fibers could make even more revenues. Many people have a moral issue about legalization of marijuana,,,,,,,wars are against morals too ...but our government supports them big time...why? Because they control the defense industry saying who can and cannot be involved.........The great minds that have ruined our country have a chance to start back up the ladder of the economy ...If they would repeal the prohibition of marijuana.

[cheteunice]

It helped after my back surgery years ago. I had no problems with it other then sleeping more.