Health Canada is considering lowering the recommended daily dose of acetaminophen following a Star investigation into the hidden dangers of the popular painkiller.

In an announcement on Thursday, Health Canada said it “is taking additional steps to minimize the risk of liver damage and improve acetaminophen safety,” citing the findings of a government review that underscored the possibility of accidental overdose.

“Our goal is that we will have fewer effects on liver, less hospitalization, less instances of unintentional overdose, and we have more people that are informing themselves about all the products that they use, not just acetaminophen,” Supriya Sharma, senior medical adviser for Health Canada’s Health Product and Food Branch, said in an interview.

Of the more than 4,000 hospitalizations in Canada each year for acetaminophen overdose, Health Canada’s report found that roughly 20 per cent are due to people exceeding the recommended dose unintentionally — and that number is rising.

The Star investigation revealed that acetaminophen, one of Canada’s top-selling non-prescription drugs over the past half century, has been responsible for hundreds of deaths, tens of thousands of hospitalizations and tens of millions of dollars in health-care system costs over the past decade.

Despite its reputation as a benign headache soother, a Statistics Canada database recorded 253 accidental deaths and nearly 300 suicides between 2000 and 2009 where acetaminophen was a major or contributing cause of death.

While Health Canada reviewed those risks and updated labelling rules only six years ago, it stopped short of mandating strong warnings recommended by its own scientists, the Star found.

Dr. Michael Rieder, a pediatric clinical pharmacologist and scientist with Western University’s Robarts Research Institute, says the new measures, which include changes to labels, an educational awareness campaign and possible revisions to dosage recommendations, are a long time coming.

“It’s time we moved on it. We have been a little slow,” he said. “We need to think about how we regulate and how we label things. Should we have acetaminophen in as many products as it is? My answer is, probably not.”

Of the 4 billion doses of acetaminophen sold in Canada each year, over half are combination products, such as over-the-counter cough and cold remedies and pain relievers containing narcotics, according to Health Canada’s report.

This is a significant concern for Dr. Constantine Karvellas, a critical-care physician at the University of Alberta Hospital, who says at least half of the 100 acetaminophen overdoses his emergency room sees each year are unintentional.

“If you have a cold, you may take Nyquil, NeoCitran and acetaminophen,” says Karvellas, who treats the worst of the worst acute liver failure cases from acetaminophen. A third of these patients die, he said.

He calls Health Canada’s latest announcement “a good first step,” but says government should also consider limiting the number of tablets consumers can purchase, as authorities have done in Britain.

The measures announced on Thursday, which were developed in consultation with patient groups, industry and others, include plans to work with stakeholders to develop an educational campaign to raise awareness about the risks of acetaminophen.

There will also be further changes to labels — Health Canada last updated label warnings in 2009 — to include a “drug facts table” with safety information, and use plainer language so consumers can “easily identify products that contain acetaminophen, understand the liver risks and use the products as directed.”

Stakeholder consultations about Health Canada’s proposals to consider lowering the recommendations maximum daily dose, which is currently four grams per day, and decreasing the dose of acetaminophen in each tablet are slated for this fall.

“It’s a unique product,” Sharma said. “We need to make sure that we’re taking all of these things into consideration to come up with the best plan to address what we see as still significant risk to the inappropriate use of it.”

Sharma said all of the recommendations Health Canada has considered since it began researching the issue are on the table.

Gerry Harrington, vice-president of policy at Consumer Health Products Canada, says his industry group, which includes members such as Johnson & Johnson, Pfizer and Bayer, and was part of the recent discussions, is “supportive” of the new regulations.

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“We’ve spent a lot of time and effort on the educational process and everyone seems to be on the same page,” he said.

With files from Jennifer Yang

By the numbers

4 billion — Number of doses of acetaminophen sold in Canada each year

475 — The number of different acetaminophen products currently authorized for marketing in Canada

4 — Number of grams of acetaminophen in the recommendation maximum daily dose

10 — Number of grams of acetaminophen per day that can lead to liver damage

4,000 — Number of hospitalizations in Canada each year for acetaminophen overdose

20 — Percentage of hospitalizations for acetaminophen overdose due to people exceeding the recommended dose unintentionally

250 — Number of cases of serious liver injury per year in Canada related to acetaminophen

50 — Percentage of cases of serious liver injury associated with unintentional overdoses