Acetaminophen debate raises arthritis care fears
A Health Canada proposal that could result in Extra Strength Tylenol being taken off the market is causing alarm among some its biggest users — arthritis sufferers.
“Acetaminophen (commonly sold as Tylenol as well as in numerous other products) is one of the medications that many people with arthritis use,” said Joanne Simons, chief mission officer with the Arthritis Society of Canada. “It is one of their medications of choice, given that there isn’t a lot available.”
The Arthritis Society and patient groups such as Arthritis Consumer Experts participated in a series of consultations Health Canada held in recent months — including one this week — to discuss proposed changes to the way acetaminophen is sold.
The popular pain medication is the leading cause of acute liver failure in Canada. In one-third of the reported cases of liver damage due to acetaminophen, patients reported they had not taken more than the daily recommended dosage, according to the federal department.
Health Canada is proposing that 500-milligram tablets of acetaminophen no longer be sold and that the daily maximum dose recommendation for the pain killer be reduced to 2.6 grams from the current four grams. It has been holding consultations with various groups in recent months on the issue.
The proposal, if adopted, would mean the end of the 500-mg “Extra Strength” Tylenol, which represents 90 per cent of product sales, said an industry spokesperson.
Organizations representing arthritis sufferers — of which there are between three and four million in Canada — say the proposals would put barriers between many arthritis sufferers and the pain medicine they rely on.
“I don’t think we understand the implications of making these changes,” Simons said. “We really feel that limiting access to medication for people with arthritis is going to have a tremendous negative impact and consequences we have not contemplated.”
Cheryl Koehn, of Arthritis Consumer Experts, the largest consumer patient organization on arthritis in Canada, is also concerned about the impact of limiting access to acetaminophen. She participated in a consultation on the issue this week and said there was widespread concern among patient groups.
“The patient groups that were there share my sentiment: There are people who are doing well on acetaminophen, so we don’t want to disrupt them.”
Koehn said her organization is concerned that Health Canada “(doesn’t) have data to support their changes.” She said officials couldn’t answer questions about whether reducing the daily maximum dosage to 2.6 grams a day would make a difference to the number of people who suffer liver damage each year from the drug.
And her organization is concerned there could be unintended consequences, such as more patients turning to opioids for pain relief.
Among ideas considered at the consultation was keeping 500-mg acetaminophen tablets on the market, but putting them behind the counter at pharmacies. She said that would act as a barrier to patients trying to access pain medication. “I can tell you we are placing more and more service provision and actual therapy burden on pharmacists.”
Many arthritis patients are unable to take other pain medication because it reacts with other drugs they are taking. Tylenol is widely used by and marketed to arthritis sufferers.
Doctors and others have raised concerns about the number of liver injuries caused by acetaminophen. One physician in British Columbia’s liver transplant program said he saw a young patient, a construction worker who took acetaminophen for work-related aches and pains, die of liver failure.
Health Canada says there are more than 4,000 hospitalizations in Canada every year for acetaminophen overdose, about 20 per cent of them unintentional.
We really feel that limiting access to medication for people with arthritis is going to have a tremendous negative impact.
A study reported in the Lancet earlier this year found acetaminophen is only slightly better than a placebo when it comes to treating osteoarthritis.
Simons said that report underlines that people with osteoarthritis need better treatment and research “to create better solutions.” But, even if it is working largely as a placebo, Simons said, it is helping patients’ pain and removing it “will increase their pain.”
Patient groups say education about safe use of acetaminophen is the key to reducing harm.