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New warning labels coming for Tylenol in Canada
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CTV.ca News Staff
Date: Tue. Jun. 30 2009 9:35 PM ET
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.
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I tend to agree with most of the comments posted. I have never seen a recall receive so much attention by the media. All auto manufacturers have recalls from time to time, it is only natural - however this time there seem to be a lot more attention given.I just wonder if it has anything to do with that the US Government are currently part owners in GM.Just wondering.


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raj
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RPK - Kitchener
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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
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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
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RPK - Kitchener
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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.
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Jim in Edmonton
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JT in AB
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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* :>(
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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
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pharmacist in AB
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Lynn in Moncton
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kaleb
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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
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Hamilton, ON
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Be Responsible
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