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Dr Mordrid
30th June 2009, 21:23
The move is because despite warning on over the counter labels acetaminophen/Tylenol overdoses are still the leading cause of liver failure. As part of the move prescription drugs containing acetaminophen would be banned; Vicodin, Percocet etc.

I'm VERY much in favor of this move as before I retired we had a shocking number of overdoses from these drugs, and IMO such cases are very much under-reported. In fact, a pharmacologist at our (quite large) institution said it was his opinion that acetaminophen never should have been approved for over the counter sales.

Link..... (http://www.reuters.com/article/marketsnews/idAFN3046243120090630?rpc=33)


US experts urge stronger limits for some pain drugs

ADELPHI, Md., June 30 (Reuters) - A U.S. advisory panel on Tuesday called for greater restrictions on the widely-used pain reliever acetaminophen, even recommending banning some medications that contain it, in a bid to prevent potentially fatal overdoses.

The Food and Drug Administration panel of outside experts, said the agency should take steps to curb the public's exposure to acetaminophen in both over-the-counter and prescription products that include the ingredient.

"I think we have to send the message that there are problems with this medication," Winifred Landis, a pharmacist from Indiana on the panel, told a two-day public meeting to discuss possible FDA action.

Overdoses of acetaminophen, perhaps best known as Johnson & Johnson's (JNJ.N) Tylenol, have long been known to cause liver failure and even death. But FDA officials are concerned current warnings are not heeded by consumers and are looking for new ways to reduce the number of overdoses.

Overall, such painkillers are safe when used as directed and liver damage is rarely seen, the agency said. But acetaminophen is the leading cause of acute liver failure in the 1,600 cases seen each year in the United States, according to a 2007 Centers for Disease Control and Prevention estimate.

The problem is that consumers sometimes take too much of the drug either by ingesting the wrong dose or unknowingly taking it via the growing number of products such as cough and cold medicines that contain acetaminophen, the FDA said.

The advisers urged a ban on prescription painkillers that include acetaminophen, such as Abbott Laboratories' (ABT.N) Vicodin and Endo Pharmaceuticals' (ENDP.O) Percocet -- two drugs that combine acetaminophen with powerful opioids.

If the agency decides against a recall, panelists said it should at least require a strong "black-box" warning on such combination products, also made by Watson Pharmaceuticals Inc (WPI.N) and Covidien Plc's (COV.N) Mallinckrodt unit.

"This is clearly the biggest cause of overdose problems," said panelist Dr. Marie Griffin, a preventive medicine professor at Vanderbilt University Medical Center. Griffin and other panelists said patients were often not aware that the powerful drugs even contained acetaminophen.

Abbott spokeswoman Elizabeth Hoff said the company would follow the agency's final decision. Other companies could not immediately be reached for comment.
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Brian Ellis
30th June 2009, 22:26
Overall, such painkillers are safe when used as directed and liver damage is rarely seen, the agency said. But acetaminophen is the leading cause of acute liver failure in the 1,600 cases seen each year in the United States, according to a 2007 Centers for Disease Control and Prevention estimate.

But what is that compared with the estimated 27000 US deaths per year from chronic liver failure due to ethanol abuse? The US already tried to eliminate ethanol abuse with the results we know. Should Laphroaig or Budweiser be obtainable only in pharmacies as prescription drugs?

A large proportion of the 1600 cases are due to deliberate overdosing in suicides (slow and very painful but ineluctable death). If that drug isn't available, another one would be used.

Edit: I wonder whether some cases may be due to the combined effects of EtOH and the drug used as a hangover "cure"

In Europe, it is known as paracetamol. I use it occasionally but never abuse it (or any other medication). Pharmacists here give oral warnings if the package contains more than a dozen 500 mg pills and especially if cold medication is bought at the same time, warning either-or, never both.

Dr Mordrid
30th June 2009, 23:40
Most common problem in my experienced is with those who have reduced liver function, particularly the elderly, popping more than they should. Sometimes they forget their most recent dose and sometimes they take all the "Tylenol is safe" hoohaw seriously, taking more than the recommended dose.

As for its use in Vicodin and Percocet: as everyone knows these drugs are highly addictive even when prescribed for pain and not abused, so when that slippery slope is hit taking more than a normal dose can cause the secondary problem of liver toxicity. This reason alone is, IMO, enough to ban them.

I have a history with Vicodin myself in that I was taking 750mg of it every 4 hours when I was undergoing all those surgeries for a hand superinfection. After a few months on that stuff, and Demerol to boot, it took another 2 months to wean me off of them, so I can really sympathize with those who have painkiller addiction. I'm lucky that I didn't slide down the slope and get into ever increasing doses.

Brian Ellis
1st July 2009, 01:27
Yup! Addiction is hell. I had a viral meningoencephalitis (complication from shingles) about 40 years ago with touch-and-go survival. After discharge from hospital, I was put on a strong regime of phenobarb: took me 3 months to break it. However, I stopped smoking (3 packs/day) while in hospital, so that was two addictions I broke, although the latter was cold turkey, probably impossible with the barbiturate.

Umfriend
2nd July 2009, 01:46
I believe over here it is never contained in certain OTC products, just as paracetamol. It's not known, by me, to be advised for colds or coughs. It's sold purely as pain reliever and fever repression.

I realise it is a dangerous substance but I see no reason to ban it. AFAIK, it is not marketed here wheras I get the impressions it is marketed in the US, thereby promoting its use, probably beyond reason.

Brian Ellis
2nd July 2009, 03:19
I believe over here it is never contained in certain OTC products, just as paracetamol. It's not known, by me, to be advised for colds or coughs. It's sold purely as pain reliever and fever repression.

Dunno about the Netherlands, but in the UK, Switzerland and this country, you can get various cough/cold OTC medications with paracetamol, e.g.


Benylin Cold & Flu Max Strength Capsules x16

Price: £2.93 (incl VAT)

Benylin Cold & Flu Max Strength Capsules contain a combination of
ingredients to help relieve the symptoms of colds and flu.

Benylin Cold & Flu Max Strength Capsules contain an analgesic (Paracetamol) and a decongestant (Phenylephrine). This cold and flu medicine starts to work quickly to relieve cold and flu symptoms, such as:

* Blocked airways.
* Headaches and pains.
* Fever.
* Sore throat.
* Fatigue and drowsiness.
* Aches and pains.

In fact, they contain 500 mg of the stuff per capsule, the same as a straight paracetamol tablet.

Also, in this country, we can get the following as a stronger analgesic than 500 mg paracetamol, although it contains only 325 mg. In fact, took two last night to counter the Flomax-caused pain.

N02AC54-DEXTROPROPOXYPHENE, COMB EXCL PSYCHOLEPT
2200193 - DESTIROL FILM COATED TABLETS
REMEDICA LTD
REMEDICA LTD
PR2 OR
ΣΥΣΚΕΥΑΣΙΑ : 50 TABS
1.0 TAB
PARACETAMOL 325.0 MG , DEXTROPROPOXYPHENE
HCL 32.5 MG
2200341 - DOLOGESIC FILM COATED TABLETS
INTERPAK LTD
REMEDICA LTD
PR2 OR
ΣΥΣΚΕΥΑΣΙΑ : 50 TABS
1.0 TAB
PARACETAMOL 325.0 MG , DEXTROPROPOXYPHENE
HCL 32.5 MG

Umfriend
2nd July 2009, 04:27
Dunno about the Netherlands, but in the UK, Switzerland and this country, you can get various cough/cold OTC medications with paracetamol, e.g.Funny that. I can;t find any quickly over here. Could be due to our Calvinistic background but then, Switzerland seems to have gone another way.

Over here, a cold is treated by simply bearing it. The pharmacists' website mentions that a postive effect of vitamine C has not been proven.

It does mention that in case of pain and/or fever one could take paracetamol. Against the pain or fever, not the cold.

Assuming that it does not help, can;t they simply forbid the companies to market product with it against cold?

Gurm
18th July 2009, 17:33
Acetaminophen is relatively worthless, comparatively speaking. Aspirin is a better analgesic and fever reducer, and Ibuprofen is superior all-around. But Tylenol is gentler on the stomach, so it got VERY popular. It also thins the blood less. Therefore, for old people - ironically, the group most affected by its dangers - it was considered "safer".