Painkiller re­form is painfully slow: ex­perts

Health Canada hasn’t shared data about ac­etaminophen over­doses, which kill on av­er­age 68 Cana­di­ans yearly


Health Canada and the mak­ers of Tylenol know how many Cana­di­ans die ev­ery year from ac­etaminophen, Canada’s most com­monly used painkiller. But they haven’t told you. The Star has ob­tained an in­ter­nal re­port from drug man­u­fac­turer John­son & John­son — never be­fore made public — that found be­tween 2000 and 2011 an av­er­age of 68 Cana­di­ans died each year be­cause of ac­etaminophen, the painkiller found in hun­dreds of prod­ucts from Tylenol to NyQuil.

The Star also ob­tained two in­ter­nal re­ports from Health Canada on use of the painkiller. Those re­ports found that nearly half of ac­etaminophen-re­lated deaths in­ves­ti­gated by coroners are “un­in­ten­tional” — peo­ple who over­dosed ac­ci­den­tally, per­haps be­cause they com­bined sev­eral prod­ucts with­out re­al­iz­ing they all con­tained ac­etaminophen.

Ac­etaminophen is very safe when taken as di­rected, and more than four bil­lion doses are sold to Cana­di­ans an­nu­ally. But the re­ports, com­pleted last year, con­tain trou­bling sta­tis­tics and sug­gest that Health Canada is drag­ging its heels on ma­jor safety re­forms rec­om­mended by its own sci­en­tific ex­perts, an on­go­ing Star in­ves­ti­ga­tion has found.

The John­son & John­son re­port, marked “con­fi­den­tial” and dated Septem­ber 2014, was re­leased in­ter­nally and never shared with Health Canada. It doc­u­ments 820 deaths as­so­ci­ated with ac­etaminophen over­dose be­tween 2000 and 2011.

The re­port also notes there were more than 26,300 ac­etaminophen-re­lated hos­pi­tal­iza­tions be­tween 2004 and 2013 — an anal­y­sis that does not in­clude Bri­tish Columbia or Que­bec.

These sta­tis­tics, along with oth­ers in the re­port, were “alarm­ing” to a se­nior in­dus­try in­sider who spoke to the Star on the con­di­tion of anonymity.

“I said, ‘My God, if Health Canada is look­ing at the same thing, we’re in trou­ble,’ ” he re­called.

He added that the re­ports trig­gered an in­ter­nal de­bate about re­duc­ing dosages and de­creas­ing pack­age sizes. No such changes have been made. A spokes­woman for John­son & John­son in Canada, Shel­ley Kohut, said the re­port’s find­ings were never shared with Health Canada be­cause they were “con­sis­tent” with what the fed­eral gov­ern­ment reg­u­la­tor had al­ready found in its own re­port, which was fi­nal­ized in Jan­uary 2014.

She added that McNeil Con­sumer Healthcare, the John­son & John­son di­vi­sion that makes Tylenol and one of sev­eral man­u­fac­tur­ers of ac­etaminophen, “has a track record of lead­er­ship” and pointed to pre­vi­ous changes to pack­ag­ing and la­belling, as well as ef­forts to ed­u­cate con­sumers, doc­tors and phar­ma­cists.

Kohut also said McNeil will con­tinue work­ing with Health Canada and other groups to “re­view and im­ple­ment risk-mit­i­ga­tion ap­proaches.”

“If a con­sen­sus emerges say­ing ad­di­tional changes are needed, McNeil will con­tinue to act in the best in­ter­est of our con­sumers in Canada and around the world,” Kohut wrote in an email.

The Health Canada re­ports ob­tained by the Star — a study ti­tled “Ac­etaminophen Spe­cial Pro­ject” — and its ex­ec­u­tive sum­mary de­tail the health reg­u­la­tor’s knowl­edge of ac­etaminophen risk.

The full re­port, writ­ten by Health Canada’s ex­perts, was not re­leased to the public. In­stead, Health Canada pub­lished a five-page sum­mary on its web­site in July, not­ing that an ex­ec­u­tive sum­mary could be re­quested. A de­part­men­tal spokesman, Sean Up­ton, says the full re­port is “avail­able upon re­quest” if peo­ple con­tact Health Canada’s mar­keted health prod­ucts di­rec­torate.

“What we’re see­ing is a pretty con­sis­tent pat­tern with Health Canada in terms of not re­leas­ing the in­for­ma­tion that they have avail­able,” said Dr. Joel Lexchin, a drug safety ex­pert at York Univer­sity. “Health Canada, in terms of its abil­ity to re­lease in­for­ma­tion in a timely man­ner, is not very good. And that’s be­ing po­lite.”

The full re­port re­veals that the public sum­mary only scratches the sur­face of what the gov­ern­ment reg­u­la­tor has learned.

The sum­mary, for ex­am­ple, says the “num­ber of hos­pi­tal­iza­tions for un­in­ten­tional over­doses is ris­ing.”

But the full re­port shows that rise has been dra­matic. “Since 2006, the pro­por­tion of ac­etaminophen over­doses re­ported as ac­ci­den­tal or unin- ten­tional has risen from 14 per cent to 21 per cent,” the re­port states.

“In the same time pe­riod, the pro­por­tion of liver in­juries as­so­ci­ated with ac­ci­den­tal or un­in­ten­tional over­dose rose from 27 per cent to 45 per cent. The rates of over­doses and liver in­juries as­so­ci­ated with in­ten­tional over­dose, how­ever, have re­mained sta­ble.”

"What we’re see­ing is a pretty con­sis­tent pat­tern with Health Canada in terms of not re­leas­ing the in­for­ma­tion that they have avail­able." JOEL LEXCHIN DRUG SAFETY EX­PERT, YORK UNIVER­SITY

In the in­ter­nal re­port, Health Canada’s ex­perts urge the im­ple­men­ta­tion of rec­om­men­da­tions in­clud­ing:

re­duc­ing the max­i­mum daily dose for ac­etaminophen to 2.6 grams from 4 grams;

re­mov­ing the drug from pre­scrip­tion opi­oid-com­bi­na­tion prod­ucts (such as Tylenol 3, which con­tains codeine);

re­quir­ing a pre­scrip­tion for “high dose” prod­ucts such as Tylenol Ex­tra Strength; and

re­strict­ing bot­tle size to 40 pills, a dra­matic re­duc­tion from the 300pill bot­tles cur­rently avail­able.

“Although these strate­gies re­quire sig­nif­i­cant changes to the way in which ac­etaminophen is reg­u­lated and mar­keted in Canada,” the re­port reads, “they are ex­pected to re­duce a mean­ing­ful pro­por­tion of ac­etaminophen over­doses, in­juries and deaths.”

Health Canada has yet to act on those rec­om­men­da­tions. In 2009, and again in July, it an­nounced new rules for ac­etaminophen la­bels. But John­son & John­son’s re­port sug­gests the 2009 changes had no ef­fect on re­duc­ing over­doses. In fact, the re­port shows over­doses slightly in­creas­ing ev­ery year since.

The health reg­u­la­tor said in July it would launch a public aware­ness cam­paign and hold a “tech­ni­cal dis­cus­sion with stake­hold­ers” this fall to dis­cuss other rec­om­men­da­tions — which, as the re­port re­veals, were given to Health Canada 18 months ago.

In an emailed state­ment, Up­ton, the Health Canada spokesman, said “help­ing Cana­di­ans use ac­etaminophen safely is a pri­or­ity.

“The length of time to com­plete the re­view was af­fected by its scope (both pre­scrip­tion and non-pre­scrip­tion ac­etaminophen prod­ucts in adults and kids) and com­plex­ity.”

But drug safety ex­perts say Health Canada’s progress on this is­sue has been “gla­cial” and “hard to jus­tify.”

“I think the pro­posed in­ter­ven­tions rep­re­sent good ideas,” said Dr. David Ju­urlink, a drug-safety ex­pert with Sun­ny­brook Health Sciences Cen­tre. “And the more Health Canada talks about them with­out ac­tu­ally do­ing any­thing, the more likely peo­ple are to be harmed as a re­sult.”

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