Calls grow for tighter control of acetaminophen

Acetaminophen, one of the most widely used and readily available painkillers in Canada, played a role in the hospitalization of Inuk activist Delilah Saunders last month with acute liver failure.

That fact surprised some of her family and friends, but it doesn’t surprise Dr. Eric Yoshida, who chairs the medical advisory committee of the Canadian Liver Foundation.

“This is something we get called about all the time,” said Yoshida, a leading liver transplant specialist in Vancouver. He just had a call this week, in fact, about a patient suffering from acute liver failure after inadvertently taking too much acetaminophen. Some of those patients recover with treatment, as Saunders did. Some receive life-saving liver transplants, and others die.

That “carnage”, as he calls it, is both under-recognized by the public and largely unnecessary, a frustrated Yoshida says.

“I am really angry about this. It seems to be constant and the worst part is it is not getting better. It is young people, it is old people, it is everybody.”

What adds to the frustration, says Yoshida, is that he believes Health Canada is not doing enough to limit the danger of acetaminophen overdoses, despite a recent safety review and new labelling requirements set to begin this year.

Acetaminophen is the leading cause of acute liver failure in Canada, sending about 4,500 Canadians, like Saunders, to hospital every year. The Ottawa woman, who is now recovering at her parents’ home in Labrador, had a history of alcohol abuse which was likely a factor, according to doctors, but her family was told acetaminophen, which she took to ease jaw pain, caused the acute liver failure.

Acetaminophen is found in about 350 over-the-counter products sold in Canada, including Tylenol. Although the majority of acetaminophen overdoses are intentional, about 20 per cent are accidental and that number has risen in recent years. Acetaminophen is more likely to cause damage in the livers of people who abuse alcohol or have underlying liver problems.

A key to preventing unintentional overdoses, Yoshida believes, would be limiting sales of acetaminophen to 325 mg tablets, which would mean the end of popular Extra Strength Tylenol, which contains 500 mg of acetaminophen.

The availability of large containers of high dosage acetaminophen, he said, makes it too easy for people to accidentally — or intentionally — take too many. “It doesn’t make any sense. There is no need for 500 mg size,” he said.

Health Canada considered limiting products to a maximum of 325 mg units that but concluded there was not enough evidence that it would improve safety. It also rejected reducing the maximum recommended daily dose from four to three grams — something done voluntarily by Johnson & Johnson, the manufacturer of Tylenol, in the U.S.

Yoshida notes that people who want to intentionally harm themselves can do a lot more damage quickly with a bottle of 500 mg tablets than with 325 mg tablets. Getting rid of Extra Strength Tylenol, he said, would prevent “several hospital admissions every year in every single province.”

Gerry Harrington, vice president of policy at Consumer Health Products of Canada, which represents Johnson & Johnson and other companies that sell products with acetaminophen, said the drug used appropriately “is extremely safe, right up to 500 mg.”

But he acknowledged that acetaminophen overdose “is an issue,” in part because of the ubiquitousness of the product.

He said stronger warning labels, including warnings that people who take more than three drinks a day should not use acetaminophen, are the best approach. Label changes, to take effect this year, will require that all products that contain acetaminophen clearly say so.

One factor in some unintentional overdoses is that people sometimes take multiple products containing acetaminophen — such as cold medications — without knowing it.

Sylvia Hyland, vice president and chief operating officer at the non-profit Institute for Safe Medication Practices Canada, called labelling changes “a step in the right direction.”

She said her organization would like to see a reduction in recommended daily doses of acetaminophen in Canada, but she added that acetaminophen plays an important role in pain management and “if people perceive it as a bad drug, they may turn to other things” such as anti inflammatories or opioids, which also carry risks.

She said putting 500 mg tablets of acetaminophen behind the counter is an option that could improve safety.

Dr. David Juurlink, head of the division of clinical pharmacology and toxicology, department of medicine, at the University of Toronto, said he believes that if acetaminophen was brought to the market today, it would not be approved because it offers minimal pain relief, although it works reasonably well at reducing fevers, and can be toxic at levels not much higher than recommended doses. There is also “emerging concern” he said about its use among pregnant women.

“The less acetaminophen the population uses the better, and the more a regulator helps people understand the potential harms and limited benefits, the better.”

While the focus of Delilah Saunders case last month was whether or not she would have qualified for a liver transplant because of her alcohol use, the role of acetaminophen in her acute illness should be getting more attention, said Yoshida.

“A death or near-death from acetaminophen overdose — whether intentional or accidental — doesn’t make the news. From my perspective, it is very dangerous.”

By the numbers

  • 4.500 Canadians are hospitalized for acetaminophen overdoses each year
  • 20 per cent of acetaminophen overdoses are accidental
  • 500 products for sale in Canada contain acetaminophen
  • 350 such products are available over the counter
  • 4 billion doses of acetaminophen are sold in Canada every year


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