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Tylenol Relabeling has not Reduced Canada’s Overdose Rate

— May 10, 2022

Acetaminophen overdoses can lead to liver failure and Canada’s new labels are helping to reduce the issue.

A recent population-based study has found that acetaminophen (aka, Tylenol) overdoses decreased by less than 1% after the Canadian government began to require that changes be made to product labeling on the over-the-counter pain medication.  The study found the new labeling has not changed the rate of hospital admissions for accidental acetaminophen overdoses at all.

The research team concluded that “beyond labeling and package information, additional measures to reduce the burden of accidental acetaminophen overdose are required.”  They published their findings about Tylenol in the April 19 online edition of the Canadian Medical Association Journal.

The team wrote, “We found that changes to acetaminophen labels that communicated the risks of overdose and the presence of acetaminophen in over-the-counter (OTC) products did not affect rates of hospital admission for accidental acetaminophen overdose, ICU admission for accidental acetaminophen overdose and admission for acetaminophen overdoses involving opioids.  Given the impacts to the public health and health systems of accidental acetaminophen overdose and the interest of policymakers worldwide in promoting the safe use of acetaminophen, our findings suggest that additional measures are needed for preventing these events.”

Tylenol Relabeling has not Reduce Canada's Overdose Rate
Photo by Artem Podrez from Pexels

Tylenol, taken as directed, is generally safe to use.  However, if an overdose occurs, it can be particularly damaging to the liver, the organ through which it is mostly metabolized.  It can be so damaging to the liver, in fact, that the Food and Drug Administration (FDA) currently recommends anyone taking this medication should not simultaneously drink alcohol.  Otherwise, an overdose is more likely to occur and lead to acute liver failure.  While there have been many cases of this happening all over the world, in Canada, “the proportion of acetaminophen-related injuries resulting from accidental overdose increased from 27% in 2006 to 45% in 2011.”

In October 2009, Health Canada required changes to acetaminophen labeling to draw attention to the risk of liver injury following an overdose.  And, in September 2016, the agency required clear and concise recognition of all OTC medications containing the drug in an attempt to prevent improper use.  Full compliance with these standards was required by March 2018.

Accessing the Canadian Institute for Health Information (CIHI) hospital discharge database, however, the researchers identified “12,212 children and adults” who had been admitted to the hospital for accidental acetaminophen overdose “between April 1, 2004 and March 31, 2020.”  Of those admitted, “2267 (18.6%) had been admitted to an intensive care unit (ICU), and 2245 (18.4%) had associated opioid overdose symptoms,” meaning they used acetaminophen along with opioids.  The population’s median age was “39 years.  Most patients (62%) were women, and some had comorbid alcohol use disorder (17%) or chronic liver disease (11%).”

WebMD lists common overdose symptoms as nausea, vomiting, a general sense of feeling unwell, an inability to eat or having a poor appetite, abdominal pain, and confusion.  The monthly rate of hospital admissions for accidental acetaminophen overdoses in Canada remained unchanged over the study despite implementing the required changes.  The rate was “0.21 cases per 100,000 people in April 2004 and 0.22 cases per 100,000 people in March 2020.”


Label Changes Did Not Cut Accidental Acetaminophen Overdoses

Impact of acetaminophen product labelling changes in Canada on hospital admissions for accidental acetaminophen overdose: a population-based study

Acetaminophen (Tylenol) Poisoning

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