Health Canada con­sid­ers low­er­ing daily max­i­mum ac­etaminophen dose


Health Canada is con­tem­plat­ing new guide­lines for ac­etaminophen, a medicine cab­i­net sta­ple that many as­sume is safe but is ac­tu­ally the lead­ing cause of se­ri­ous liver in­juries in Canada.

The depart­ment is re­view­ing the max­i­mum rec­om­mended daily dose of ac­etaminophen. It is also look­ing at ex­tra strength and ex­tended re­lease for­mu­la­tions, a Health Canada of­fi­cial said Thurs­day in an in­ter­view.

Dr. Supriya Sharma said Health Canada will be work­ing with pro­vin­cial and ter­ri­to­rial part­ners on the is­sue, try­ing to de­ter­mine whether some for­mu­la­tions ought to be moved be­hind phar­ma­cists' coun­ters.

Prov­inces and ter­ri­to­ries de­cide whether a prod­uct is sold over the counter or from be­hind the counter, she said.

“We're look­ing both at what the ... max­i­mum unit dose should be for non-pre­scrip­tion prod­ucts and pre­scrip­tion prod­ucts as well as what should be pre­scrip­tion and non-pre­scrip­tion,” said Sharma, se­nior med­i­cal ad­viser in the health prod­ucts and food branch.

In ad­di­tion, Health Canada may re­quire that all chil­dren's liq­uid med­i­ca­tions that con­tain ac­etaminophen be sold with an ac­cu­rate dos­ing de­vice to min­i­mize the risk of over­dose.

Ac­etaminophen over­doses are re­spon­si­ble for an es­ti­mated 4,000 hos­pi­tal­iza­tions a year in this coun­try. Health Canada says there are more than 250 cases of se­ri­ous liver in­jury in Canada each year re­lated to ac­etaminophen, and over half of those are due to un­in­ten­tional over­dose.

In fact, a re­cent fed­eral re­port on ac­etaminophen found that the num­bers of un­in­ten­tional over­doses in­volv­ing the drug are on the rise in Canada.

Ac­etaminophen is a com­monly used fever sup­pres­sant and pain med­i­ca­tion. It's best known as the drug in Tylenol. But it is also found in myr­iad other reme­dies sold to al­le­vi­ate symp­toms of colds, in­fluenza and si­nusi­tis. In fact, Health Canada says more than 475 prod­ucts con­tain­ing ac­etaminophen are li­censed for sale and most are sold with­out pre­scrip­tion.

Dr. Michael Rieder, who holds a chair in pe­di­atric phar­ma­col­ogy at Western Univer­sity in Lon­don, Ont., said the fed­eral gov­ern­ment should look at those com­bi­na­tion prod­ucts and talk to man­u­fac­tur­ers about the is­sue.

Ac­etaminophen may not add much ben­e­fit for the user in some of the com­bi­na­tion prod­ucts con­tain­ing the drug, Rieder said. But con­sumers may not be aware that the cold reme­dies they are tak­ing con­tain the drug, so they could take ac­etaminophen on top of the cold med­i­ca­tion.

“Fif­teen years ago in Canada, ac­etaminophen was just ac­etaminophen. We didn't have it in ev­ery other prod­uct known to man,” he said.

Rieder also ques­tioned the ex­tra strength for­mu­la­tions, say­ing they may not carry added ben­e­fit but likely are a source of added risk.

Sharma said the depart­ment knows some chronic pain suf­fer­ers rely on ex­tra strength for­mu­la­tions. She said Health Canada is try­ing to strike a bal­ance be­tween pro­vid­ing con­sumers with choice and low­er­ing the risk the drug poses.

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