Acetaminophen product makers told by Health Canada to boost warnings

Health Canada has told makers of over-the-counter products to provide clearer label instructions and stronger warnings on products containing acetaminophen in an effort to prevent liver damage.

Acetaminophen is used safely by the vast majority of Canadians, the regulator said in making the announcement Thursday.

But it comes with risks, especially if taken for longer than directed.These risks include liver damage, which in severe cases can lead to liver failure anddeath.

• Health Canada may lower daily maximum acetaminophen dose
• Improved labelling coming for over-the-counter and prescription drugs
  

Acetaminophen is commonly associated with Tylenol.More than 475 different acetaminophen products are authorized for sale in Canada,the majority being non-prescription. These includecombination products such asNyQuilandNeoCitran,as well asprescription medications.

Some of the instructionswill warn consumers to:

• Use the lowest effective dose.
• Not exceed fourgrams for adults in a 24-hour period.
• Usethese products for no more than five days for pain or three days for fever.
• Avoid mixing them with alcohol if drinking three or more drinks in a day.

Makers will be required to highlight that a product contains acetaminophen in bold, red lettering on the front of the package and to providecalibrated devices for all liquid children's products.

Acetaminophen has been sold in Canada since 1961, saidDr.SupriyaSharma, senior medical adviser with Health Canada's health products and food branch in Ottawa.

Check the label

"When it's in as many products as it is, and when people have a familiarity with the products, there may be less of a likelihood that somebody will actually read the label," Sharmatold reporters.

The label changes are effective immediately for all new products and within 18 months for existing ones.

• 3 deaths in Iqaluit related to prescription Tylenol overdose

A newdrug factstable will also be required for packages to provide product instructions, warnings and other safety information in a consistent, quick-reference format, effective2021.

The changes are based on the regulator's safety review on the drug released last year.

Health Canada's 2015 Acetaminophen Reportshowed more than 250 cases of serious liver injury every year related to acetaminophen.

About20 per cent of thecases are due to people exceeding the recommended dose unintentionally. In many of these cases, patients had identifiable risk factors for acetaminophen liver injury, such as alcoholism or viral liver disease, according to the report.

'Death by Tylenol'

Dr. Eric Yoshida is a liver specialist at Vancouver General Hospital, where he regularly sees patients from across British Columbia and Yukonwith severe liver failure frominadvertent acetaminophen overdoses.

"We've had patients who have died waiting for liver transplantation, a transplant that never came," said Yoshida, who is alsochair of the Canadian Liver Foundation'smedical advisory committee. "They're in our ICU with acute liver failure and the cause is inadvertent Tylenol injury death by Tylenol. This is completely avoidable. I'm all in favour of increased public awareness and better labelling."

Yoshida would like to seethe amount of acetaminophenin each capsule or tablet limited to the regular strength dose of325 milligrams, rather than the 500 milligrams found in extra-strength products.Otherwise, people may not be aware they're taking 1,000 milligrams from two extra-strength pills.

In the United Kingdom, regulators have talked about limiting the number of acetaminophentablets per package, said Dr.Michael Rieder, who holds a chair in pediatric pharmacologyat Western University in London, Ont.

In the case of baby Aspirin for example, there's good Canadian data to show that a limited-package-sizeapproach worked, Rieder said.

Overall, Rieder called Health Canada's acetaminophen labelchanges sensible. But he'd also like to see the top dose per tablet reduced from the current 500 milligrams in extra strength products.

"Extra strength isn't always extra value," Riedersaid in an interview.

Sharma said Health Canada heard concerns from patient groups who feared that limiting the daily maximum dose or restricting access to extra-strength formulations of acetaminophen could drive patients towards opioidsandother pain medications with more serious side-effects on the liver or kidneys. She added the issue didn't come up in the regulator's review of the medical or scientific literature.

Health Canada also plans to spread the word about the label changesthrough social media channels. Industry initiatives, such as Tylenol Canada's GetRelief Responsiblyandthe Know your Dose program in the U.S., also play a role,Sharma said.