Updated: Tue Jun. 30 2009 9:35:50 PM

CTV.ca News Staff

Canada plans to bring in new warning labels on acetaminophen -- the key ingredient in Tylenol, Excedrin and other medications -- while government experts in the United States on Tuesday said the maximum dose should be reduced to avoid lethal overdoses.

Acetaminophen is one of the most widely used drugs in the U.S and Canada. Many patients find it easier on the stomach than other painkillers like ibuprofen and Aspirin, which can cause ulcers.

Unfortunately, acetaminophen is also the leading cause of liver failure in the U.S., sending 56,000 Americans to the emergency room annually.

The new labels for acetaminophen products in Canada will include warnings about liver toxicity, including specific information for people with serious kidney and liver disease and alcohol users, said Health Canada spokesperson Christelle Legault. The new labeling standard is scheduled to take effect in September.

Meanwhile, on Tuesday, a panel for the U.S. Food and Drug Administration endorsed lowering the maximum dose of over-the-counter acetaminophen.

FDA's experts voted 21-16 to lower the current maximum daily dose of non-prescription acetaminophen, which is four grams (4,000 milligrams), or eight pills a day of a medication such as 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 mg, or two tablets.

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

But panellists rejected a proposal to pull NyQuil, and other cold and cough medicines that combine acetaminophen with other drugs, off the market.

Although the FDA said patients often pair combination drugs, like NyQuil or Novartis' Theraflu, with pure acetaminophen treatments, like Tylenol, exposing themselves to unsafe levels of the drug, the panel said those medications play a minor role in acetaminophen overdoses, with only 10 per cent of acetaminophen-related deaths involving a cold and cough product.

The FDA is not obligated to follow the recommendations of its advisory panels, but it typically does so.

Health Canada officials are attending the ongoing FDA meetings to gain further information on acetaminophen.

"Information presented at these meeting will be taken into account in any Canadian regulatory decisions," said Legault.

Comments are now closed for this story

raj
Saying pain medications are 'popular' seems weird.

RPK - Kitchener
The "FDA"is acting resonsible, and in the long term interest of the public ~ THAT's THEIR JOB!

If this panel of experts agree, that these over the counter elixers are dangerous, than by all means get them off the shelves of all distributors.

It is the public safety, and intersts that must prevail, not the bottom line earnings of the major manufacturers.

Corporate Profits have led us, so many times, into major medical and financial disasters.

Lets all back the "FDA" and their efforts in our behalf.

sue ottawa
I am not sure if all the facts are in this article, but as a sufferer of osteoarthritis in certain joints, and a person who does not want to go to prescriptions drugs such as Celebrex, taking Tylenol
arthritis off the market would concern me. however it would still be sold in Canada I assume since the FDA only has control over the US.

Dave
Has there been a correlative study on the effects of liquor and liver failure? Or tobacco and lung cancer? Or sun worship and skin cancer? How about eating habits and obesity? All of the above are as equally accessible and cause even more long term effects and deaths than overuse of acetaminophen.

RPK - Kitchener
TO: Sue Ottawa

We all know the FDA is an American Agency and their authority doesn't apply to CANADA.

HOWEVER ! If this agency (a hundred times more efficient than our Food & Drug Czars) says it is harmful to health - than that's is good enough for me to not use these prodcuts.

I don't wait on our Government to act, just look a the food inspectors we have (or do we have any).

Darlene in B.C.
It is getting to me about the 'regulated babysitting' of all aspects of our lives. We, who have a brain, do not need it but we have to 'pay' for it because of people who haven't learned how to be responsible. DON"T take an excessive amount of anything!

Jim in Edmonton
Like many people, I live with cronic and severe pain. I take one t-3 per day and one perocet at night. Maybe a couple of regular tylenols on top of that from time to time. Most people like me take the minimum necessary and what they can get away with. I destroyed my body doing extremely hard lifting and labour work to feed my family. Without pain medication I could not cope. I have been to all the pain specialists, chiro's, physio etc. My doctor tells me not to worry about it, just do the best you can. Most doctors with patients like me are not going to see us live in misery. Ps. I cannot take asa because of an ulcer.

JT in AB
Let's put this in perspective.

Acetaminophen is not the issue. Dosage may be. If reducing the dosage recommendations helps reduce overdoses then why not.

My only concern is people panicking and pulling these products off the shelves. The products are fine but people need to be aware that these ARE medications and should be used as such. Move it behind the counter if need be.

Now my personal comment: If you are taking medications why would you be so stupid as to NOT read the label and warnings? If you're not sure ask the pharmacist, they are usually more than happy to answer questions. Personal responsibility has to enter the equation somewhere.

Jeannette *chronic pain sufferer* :>(
Between this article and all the others slamming drug addiction for death such as in the case of Michael Jackson, it makes life more difficult for those with chronic pain.


I have horrid chronic pain as a result of a workplace injury and I need these meds just to survive. There are many people out there abusing drugs that make it difficult for those with legitimate pain. I am stuck in a catch-22. I take them and attempt to cope or don't and end up in a fetal position wishing for death.

If there is so much concern about analgesics, why isn't there more research being done and new ones invented to help people without all the side-effects and addiction possibilities? If there was a safer option that worked well available, I'd be 1st in line to try it. No one (other than drug addicts) wants to take such meds, but those that are suffering such as myself, have no choice in the matter if they wish to get out of bed...How about some effort being put upon finding new effective analgesics that will not cause all of these issues?? I'm just saying...

Georgia, Toronto, ON
Oh do NOT put your faith in the FDA, don't you see the commercials for the ambulance chasing lawyers on American network TV? 'Have you or a loved one suffered from (litany of symptoms) after taking prescribed X? You May be entitled to money, call us..." Big pharma are heavy lobbyists, a lot of things that should NOT get approved, do get approved and they are a lot more harmful than Tylenol.

pharmacist in AB
As a pharmacist, I agree with JT in AB about people should take more responsibility on what they take. We, pharmacists, are always available for consultation if people are unsure. Do not just take any over-the-counter medications without reading the label, especially cough and cold products as most of them have acetaminophen. Again, of course acetaminophen is a safe drug if used within the right dose (under 4g/day) but if you use other drugs (even prescription drugs), you might be exposed to acetaminophen than what you think you are taking. For examples, Percocet (acetaminophen+Oxycodone), Tramacet (Tramadol+acetaminophen), Tylenol #1,#2,#3,#4 and Emtec.

Lynn in Moncton
Anything the FDA says goes in one ear and out the other. They have absolutely no credibility as far as I'm concerned.

kaleb
We have known the dangerous of acetaminophen for a very long time now. We know it is the leading cause of liver failure (Dave said alcohol is worse but that is not true alcohol is the number 2 cause of liver failure). I have been telling people just how dangerous this drug is and people act like I am crazy. Hopefully now people will open their eyes to the dangerous of acetaminophen abuse.

They need to stop putting acetaminophen in otherwise safe medications. If you take to many T3s, its not the codeine that will kill you its the acetaminophen.

Donna in Ottawa
I have an allergy to NSAID's (ASA and related drugs) which makes acetiminophen my only choice for pain relief. I have been asking pharmacists and doctors for alternatives and there are none. Before we take these drugs off the shelves, please stop to think about people like me who have no other choice.

Hamilton, ON
Try cannabis for pain. NO ONE HAS EVER HAD A FATAL OVERDOSE FROM CANNABIS. The FDA and DEA are both flawed agencies which care not about people. Furthermore, any of our food and drug people are obviously lost in their bureaucratic sense of dictatorship. I think they should forget these kind of common sense things and move to real issues like contaminated meat and chemically-altered foods from China which slip into our markets daily.

Be Responsible
Too many people seem to think that if something is on the shelf, as opposed to over-the-counter or prescription, then they can take as much as they want. Combine that with those expecting instant relief (and when they don't get it, they pop more pills), and there is no wonder that there are so many instances of pain-killer overdose. NON-PRESCRIPTION DOES NOT MEAN HARMLESS! Be careful and read the labels - all of them!