Canada settles for borderline warning on dangers of acetaminophen
Dear Reader,
Regulators had the opportunity to save lives, but in the end Big Pharma won.
For years, Canadian Health officials have been discussing what to do about acetaminophen, the active ingredient in Tylenol.
Just this spring, I told you how doctors, researchers and families of those who had been harmed by the drug were cheering. It looked as if Canada was on the brink of making big changes that would protect its citizens and lead the way in regulating this risky med.
But it was also something that had drugmakers in a panic.
Because if people really knew just how dangerous acetaminophen is, no one would touch it with a ten-foot pole.
“It’s underwhelming.”
That comment by Dr. David Juurlink, a drug expert with Sunnybrook Health Sciences (one of Canada’s largest hospitals), kind of sums up the whole situation.
Just a few short months ago, he and many others were expecting Health Canada to finally show the FDA what safety measures were urgently needed where acetaminophen is concerned. For example, chopping the maximum daily dose from a whopping 4,000 mg (what it is in the U.S.) down to 2,600 mg.
And that would have put the kibosh on most all sales of Extra Strength Tylenol, which comprises around 90 percent of Johnson & Johnson’s Tylenol business.
Another expected change was to ban giant bottles of drugs containing acetaminophen. Unbelievably you can walk into any Walmart right now and buy a bottle of 225 Tylenol pills at 650 mg each!
But none of those changes came to pass. So I’m sure that Big Pharma must have been having a party last week when the Canadian health officials finally announced what they had decided on — which wasn’t much.
For example, now drugmakers have to print “clearer warnings,” especially about not taking the drug with over three alcoholic drinks a day.
Seriously?
Years ago I warned you that even “light drinking” while taking this med can up your risk of kidney disease by over 100 percent! Giving the green light to three drinks a day is practically suicide for your kidneys!
Another weak-kneed warning included marking packages with red letters saying “contains acetaminophen” like we do in the U.S.
But it’s going to take a lot more than this to keep people safe.
As an eAlert reader, you know how dangerous this drug is. Over the years I’ve shared many stories about people who accidentlly crossed that “narrow therapeutic window” between the dose on the bottle and the dose that sends you to the ER. Or the dose that puts you on the liver transplant list.
This med is so risky that experts such as Dr. Juurlink have said that if Tylenol was a new drug, its chances of approval today would be slim to none.
Canadian regulators didn’t say much about why they decided against the proposed safety changes. The only comment was some official gibberish about new research “casting doubt” on whether reducing the bottle size will prevent suicides.
But while industry groups applauded, Canadian doctors, especially ER physicians, weren’t putting on any party hats.
Although Canada didn’t end up leading the way in acetaminophen safety as many had hoped, it still brings this “serious public health problem” into the limelight again.
As I’ve told you, this drug sends around 78,000 people in the U.S. to the ER every year and is the leading cause of acute liver failure. You can take the recommended dose and still end up in trouble.
Since the drug is in hundreds of OTC and Rx products it’s very, very easy to be just one pill away from a deadly overdose and not know it — until it’s too late.
And that’s the warning that really belongs on bottles of acetaminophen.
Sources:
“Experts ‘disappointed’ Health Canada not doing more to address acetaminophen dangers” Jennifer Yang, September 15, 2016, The Star, thestar.com
