FDA On Removing Vicodin, Percocet From Market & Limiting APAP: Merged Thread

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FDA Panel Urges Cuts in Acetaminophen Dosage
Concerns Over Unintentional Overdose Hazards May Change How Drug Is Marketed

By DAN CHILDS
June 30, 2009

An expert panel convened by the U.S. Food and Drug Administration voted today to recommend greater regulation of acetaminophen -- the most commonly used painkiller in the country.

An expert panel convened by the U.S. Food and Drug Administration voted today to recommend greater regulation of acetaminophen in response to overdose fears.

Midway through a series of votes, the panel at the Center for Drug Evaluation and Research Joint Meeting of the Drug Safety and Risk Management Advisory Committee, the FDA's Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee has already voted to urge the FDA to switch to prescription status the strongest of the over-the-counter acetaminophen products, which contain a 1,000 mg dose.

The decision affects a variety of popular over the counter products, including the recommended dosage of Extra Strength Tylenol and other Tylenol products. The dosing instructions for Extra Strength Tylenol indicate that adults should take two 500-mg tablets every 4 to 6 hours.

link
 
I hope this works it's way to painkillers which contain Paracetamol being lowered (i.e. instead of Vicodin containing 5mg Hydrocodone and 500mg Paracetamol, it would change to 200mg Paracetamol).
 
FDA panel recommends smaller doses of painkillers

AP

By MATTHEW PERRONE, AP Business Writer Matthew Perrone, Ap Business Writer – 1 hr 53 mins ago

ADELPHI, Md. – Government experts say prescription drugs like Vicodin and Percocet that combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses.

A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.

The FDA has assembled a group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the U.S.

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA.

Panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products. Acetaminophen is also found in popular over-the-counter medications like Tylenol and Excedrin.

"We're here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact," said Dr. Judith Kramer of Duke University Medical Center.

But many panelists opposed a sweeping withdraw of products that are so widely used to control severe, chronic pain.

"To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake," said Dr. Robert Kerns of Yale University.

In a separate vote, the panel voted overwhelmingly, 36-1, that if the drugs stay on the market they should carry a black box warning, the most serious safety label available.

The FDA is not required to follow the advice of its panels, though it usually does.

Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to FDA data. Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both painkillers also are available in cheaper generic versions.

The FDA convened the two-day meeting to ask experts to discuss and vote on a slew of proposals to reduce overdoses with acetaminophen. The drug has been on the market for about 50 years and many patients find it easier on the stomach than ibuprofen and aspirin, which can cause ulcers.

Earlier in the day, panelists took aim at safety problems with Tylenol and dozens of other over-the-counter painkillers. In a series of votes, the panel endorsed lowering the maximum dose of those products.

FDA's experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol.

The group was not asked to recommend an alternative maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Johnson & Johnson's Extra Strength Tylenol is 1,000 milligrams, or two tablets.

In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription.

However, panelists rejected a proposal to pull certain cold and cough medicines off the market because of their role in overdosing.

The drugs in question, such as Procter & Gamble's NyQuil or Novartis' Theraflu, combine acetaminophen with other ingredients that treat cough and runny nose.

The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.

But panelists cited FDA data that said the medications play a minor role in acetaminophen overdoses, with only 10 percent of acetaminophen-related deaths involving a cold and cough product.

"I don't think we should be advocating a solution to a problem that really is not there," said Dr. Osemwota Omoigui, of the Los Angeles pain clinic.

The panel voted 24-13 to keep the products on the market.
Click to expand...

http://news.yahoo.com/s/ap/20090630/ap_on_he_me/us_tylenol_safety_fda
 
FDA panel votes to eliminate Vicodin, Percocet

Deadly overdoses of acetaminophen, narcotics are cited in recommendation

Associated Press
updated 3:31 p.m. ET, Tues., June 30, 2009

ADELPHI, Md. - Government experts say prescription drugs like Vicodin and Percocet that combine a popular painkiller with stronger narcotics should be eliminated because of their role in deadly overdoses.

A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market.

The FDA has assembled a group of experts to vote on ways to reduce liver damage associated with acetaminophen, one of the most widely used drugs in the U.S.

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., according to the FDA.

Panelists cited FDA data indicating 60 percent of acetaminophen-related deaths are related to prescription products. Acetaminophen is also found in popular over-the-counter medications like Tylenol and Excedrin.

“We’re here because there are inadvertent overdoses with this drug that are fatal and this is the one opportunity we have to do something that will have a big impact,” said Dr. Judith Kramer of Duke University Medical Center.

Many opposed to recommendation
But many panelists opposed a sweeping withdraw of products that are so widely used to control severe, chronic pain.

“To make this shift without very clear understanding of the implications on the management of pain would be a huge mistake,” said Dr. Robert Kerns of Yale University.

In a separate vote, the panel voted overwhelmingly, 36-1, that if the drugs stay on the market they should carry a black box warning, the most serious safety label available.

The FDA is not required to follow the advice of its panels, though it usually does.

Prescription acetaminophen combination drugs were prescribed 200 million times last year, according to FDA data. Vicodin is marketed by Abbott Laboratories, while Percocet is marketed by Endo Pharmaceuticals. Both painkillers also are available in cheaper generic versions.

The FDA convened the two-day meeting to ask experts to discuss and vote on a slew of proposals to reduce overdoses with acetaminophen. The drug has been on the market for about 50 years and many patients find it easier on the stomach than ibuprofen and aspirin, which can cause ulcers.

Panel voted to lower maximum acetaminophen dose
Earlier in the day, panelists took aim at safety problems with Tylenol and dozens of other over-the-counter painkillers. In a series of votes, the panel endorsed lowering the maximum dose of those products.

FDA’s experts voted 21-16 to lower the current maximum daily dose of nonprescription acetaminophen, which is 4 grams, or eight pills of a medication like Extra Strength Tylenol.

The group was not asked to recommend an alternative maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of the drug to 650 milligrams. The current single dose of Johnson & Johnson’s Extra Strength Tylenol is 1,000 milligrams, or two tablets.

In a third vote, a majority of panelists said the 1,000-milligram dose should only be available by prescription.

However, panelists rejected a proposal to pull certain cold and cough medicines off the market because of their role in overdosing.

The drugs in question, such as Procter & Gamble’s NyQuil or Novartis’ Theraflu, combine acetaminophen with other ingredients that treat cough and runny nose.

The FDA says patients often pair the cold medications with pure acetaminophen drugs, like Tylenol, exposing themselves to unsafe levels of the drug.

But panelists cited FDA data that said the medications play a minor role in acetaminophen overdoses, with only 10 percent of acetaminophen-related deaths involving a cold and cough product.

“I don’t think we should be advocating a solution to a problem that really is not there,” said Dr. Osemwota Omoigui, of the Los Angeles pain clinic.

The panel voted 24-13 to keep the products on the market.

link
 
I've seen my mom eat a vicodin(after surgery) then eat a Tylenol extra strength then some nyquil. This is an example of how some people eat acetomeniphen products daily. People do this because they have no idea how many products hAve this drug and how bad it can be when taken in excess for extended periods of time. About time.
 
This is a great idea in theory--acetaminophen is more harmful than opioids and it does cause a great deal of damage to the liver.

However, are doctors going to be willing to replace these drugs with other pure opioids without any other medicine combinations?

Doctors are already hesitant enough to write these as prescriptions, but if their only choice is to script a drug without Tylenol or any other drug, there's going to be a lot more people in pain to prevent the small majority of people from being addicted to these drugs.

BS in my opinion.
 
Too many doses said:
^ Its not outlawing acetominephen its lowering the amount that can be in products. Instead of a 5/500 combo it would be a 5/200 or something.
Click to expand...

"A Food and Drug Administration panel on Tuesday voted 20-17 that prescription drugs that combine acetaminophen with other painkilling ingredients should be pulled off the market."

That's a quote from the article, so I think that if they do stay on the market they're going to just lower them, but they could do either.

Hopefully it's what you said :)
 
These products are a design of the Controlled Substances Act. Products combined with APAP or other non-narcotic drugs are scheduled lower than narcotic-alone products (Codeine, Hydrocodone, DHC, etc are CII unless combined with other products). I guess doctor opiophobia contributes to widespread CII combination product scripting (Percocet, etc). Even though OxyIR are in the same schedule.

They should be pulled off the market. The provision should be removed from the CSA. It hasn't stopped anyone from getting high; it has only caused immeasurable damage and death.
 
FDA panel BANS VICODIN & Percocet + more

Just like the headline says, an FDA panel has voted 20-17 to ban all prescription medications that combine acetaminophen and narcotic painkillers such as vicodin and percocet and tylox or whatever else you can think of that fits those categories. Reason being is that the liver damage is extent with acetaminophen and highly contributed by those types of scripted pills. Anyway, i also used the effing search engine. My question pertains to this and this can be a good thing in my mind. I never was a fan of any pk's that are not "pure" in that they only have one active ingredient. i.e. oxycodone, morph., and so on. My question is this: Will getting pain pills that are pure be more accessible now? My whole deal was that I did not want to hassle at the doctors office even though I am in pain just to get some perc or vicodin, I hate those extra drugs that are in them. I would rather not take them at all than ingest something that will kill my liver and does not suffice to kill pain appropriately. Is this a good thing? And will oxy and more pure" painkillers be more widely available? (Keep in mind most overdoses and fatalities I believe reading somewhere are associated with painkillers that are in combination with another drug such as tylenol etc.) Thx
 
The FDA is not required to follow the advice of its panels, though it usually does.

this would be better suited for drugs in the media sub-forum and i cannot see this actually going into affect anytime soon
 
You do not think this will take affect soon? If it typically follows the advise of it's panels,... I would come to the conclusion that this will indeed come to fruition.. maybe not necessarily next week though
 
it's a preliminary panel not the whole FDA. They want to pull OTC products is what I saw on the news. Outlawing a drug is different than restricting it's use, I can't see them outlawing Tylenol as that'll show that the most popularly used pain reliever in the USA is more dangerous than opiate prescription meds, that'll be a black eye for sure.
 
realistically i dont even see this happening in a years time. unless they got a formulated plan on home to replace the meds that thousands of ppl are on daily for pain. more or less this will just end up being a study of research with no real outcome anytime soon. banning the distribution of all pain meds with apap in them just isny feasible. perhaps the solution that comes about is lowered dosages of the apap in the same formulations of these meds
 
I think you have to be pretty retarded to be taking more than 4 grams of APAP / day and still think you'll be A-OK forever. I mean come on.. People who are OD'ing on APAP probably weren't the sharpest tools in the shed..
 
Another expert took a different view. Dr. John H. Klippel, chief executive officer of the Arthritis Foundation, said Tuesday's votes were very important to "people with arthritis because acetaminophen is a very commonly used medication to control pain."
Click to expand...

I wonder what pharm manufacturers are behind this foundation or invest in it? Correct me if I am wrong but wouldn't you want an OTC preparation for arthritis that is an anti-inflammatory AND an analgesic? APAP does not work as an anti-inflammatory at all, so really, there are plenty of other, more effective, and SAFER OTC options out there for arthritis relief.
 
Personally I dont think this will ever happen, the lobbies will take care of it, but I heard they will just reformulate with ibuprophen on the vikes and percs. But I just cannot believe apap/paracetamol will be taken off the market.

ShadyMyster's title is , well...shady, they have not been banned, everyone can happily take their scripts of Norco, lortab, percocet, and vicodin to their pharmacies and be filled. :)
 
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