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Popular infant teething gels removed from Canadian pharmacies without notice
by Michelle Ward,1 CBC News
Jan 29, 2020
Some health professionals concerned that stronger, adult versions are still being used for teething babies
Jenn Akeson, a mother of two, said her 17-month-old daughter is up at night from teething pain. (Submitted by Jenn Akeson)
A popular class of baby teething pain relievers has been quietly pulled from pharmacy shelves in Canada.
The children's versions of Orajel and Anbesol's gum-numbing products are no longer available on the Canadian market, the companies confirmed to CBC News, without providing a reason. Little Teether's parent company no longer lists its teething product on its website, but did not respond to queries.
Used for decades, the products' active ingredient, benzocaine, can cause methemoglobinemia, a rare but potentially fatal condition in which blood oxygen levels drop.
U.S. regulators ordered companies to stop selling infant teething products containing benzocaine in 2018, saying they "carry serious risks and provide little to no benefit for the treatment of oral pain including teething."
Canada has required warnings since 2012, but has not banned benzocaine-containing products for use on the skin or in the mouth for adults or children.
After the U.S. ban in 2018, Health Canada asked manufacturers to "update their product labels to ensure they contained all the appropriate risk labelling," it said in an emailed statement. "Affected manufacturers either changed their labels as requested or discontinued the sale of their products in Canada."
Some health professionals remain concerned, however, that adult versions, which are more potent, are still being used for teething babies.
"We can't assume that only products marketed for children will be used for children," said Nardine Nakhla, a pharmacist who teaches at the University of Waterloo, "I have no doubt that there will be some confusion when parents are used to a certain brand name and they may not pay attention to the fact that it's not the kids' version."
'No recall'
That fear appears justified. A Medical Post survey suggested Orajel was the number one recommended baby teething product by physicians in 2018 and 2019. And Nakhla says many pharmacists still don't know the products have been discontinued.
"There was no recall. There was no manufacturer withdrawal notice."
Dr. Mike Dickinson, head of pediatrics at the Miramichi Regional Hospital in Miramichi, N.B., and a past president of the Canadian Paediatric Society, says he didn't realize the products had been discontinued either.
Parents may not pay attention to the fact that the product they purchase is not the kids' version, said Nardine Nakhla. (Submitted by Nardine Nakhla)
"[I am] surprised that it never crossed my desk or computer screen," he said, agreeing that the lack of awareness is potentially a problem.
In his region, multiple generations often support young families and he worries about grandparents buying teething gels they used for their children decades ago without realizing that they are no longer meant for babies.
At a recent playgroup in Ottawa, parents were surprised to hear that the teething gels were no longer available.
Jenn Akeson, a mother of two, said her 17-month-old daughter had been "tossing and turning" from teething until midnight the night before. Her family doctor had told her not to use teething gels, but she didn't know the reason for this warning. She uses natural ways to soothe her daughter's teething pain, like giving her frozen fruit to chew on. But, she said, "sometimes it isn't enough."
For its part, Health Canada would only say that two Baby Orajel products were "voluntarily recalled" in May 2018 and would not discuss other products, saying it "could not comment on product availability as that is a marketing decision by the manufacturer." The department's statement said 140 benzocaine-containing natural health products and three non-prescription drugs continue to be approved for sale in Canada.
Dickinson said that medications and other products are usually not needed for infant teething. He says that if babies start drooling, chewing, or showing other signs of teething, parents can offer them a wet facecloth that has been cooled in the freezer or can give them a rubber teething ring that is meant for that purpose. Parents can also rub their babies' gums.
For the child with occasional trouble sleeping while teething, a dose of an analgesic, such as acetaminophen, can be useful, said Dr. Mike Dickinson. (Submitted by Mike Dickinson)
He said the occasional child will have trouble sleeping while teething, and a dose of an analgesic, such as acetaminophen, can be useful. But parents should avoid products that contain alcohol or an anesthetic like benzocaine, as these are potentially toxic for children.
Orajel's benzocaine-containing infant teething gels have been replaced on Canadian pharmacy shelves by homeopathic remedies, some of which contain alcohol.
"Teething is not as big a deal as sometimes it's made out to be and the vast majority of kids sail through the teething period with very mild to no symptoms," says Dickinson.
1 Michelle Ward is a pediatrician, associate professor of pediatrics and journalist in Ottawa.
by Michelle Ward,1 CBC News
Jan 29, 2020
Some health professionals concerned that stronger, adult versions are still being used for teething babies
Jenn Akeson, a mother of two, said her 17-month-old daughter is up at night from teething pain. (Submitted by Jenn Akeson)
A popular class of baby teething pain relievers has been quietly pulled from pharmacy shelves in Canada.
The children's versions of Orajel and Anbesol's gum-numbing products are no longer available on the Canadian market, the companies confirmed to CBC News, without providing a reason. Little Teether's parent company no longer lists its teething product on its website, but did not respond to queries.
Used for decades, the products' active ingredient, benzocaine, can cause methemoglobinemia, a rare but potentially fatal condition in which blood oxygen levels drop.
U.S. regulators ordered companies to stop selling infant teething products containing benzocaine in 2018, saying they "carry serious risks and provide little to no benefit for the treatment of oral pain including teething."
Canada has required warnings since 2012, but has not banned benzocaine-containing products for use on the skin or in the mouth for adults or children.
After the U.S. ban in 2018, Health Canada asked manufacturers to "update their product labels to ensure they contained all the appropriate risk labelling," it said in an emailed statement. "Affected manufacturers either changed their labels as requested or discontinued the sale of their products in Canada."
Some health professionals remain concerned, however, that adult versions, which are more potent, are still being used for teething babies.
"We can't assume that only products marketed for children will be used for children," said Nardine Nakhla, a pharmacist who teaches at the University of Waterloo, "I have no doubt that there will be some confusion when parents are used to a certain brand name and they may not pay attention to the fact that it's not the kids' version."
'No recall'
That fear appears justified. A Medical Post survey suggested Orajel was the number one recommended baby teething product by physicians in 2018 and 2019. And Nakhla says many pharmacists still don't know the products have been discontinued.
"There was no recall. There was no manufacturer withdrawal notice."
Dr. Mike Dickinson, head of pediatrics at the Miramichi Regional Hospital in Miramichi, N.B., and a past president of the Canadian Paediatric Society, says he didn't realize the products had been discontinued either.
Parents may not pay attention to the fact that the product they purchase is not the kids' version, said Nardine Nakhla. (Submitted by Nardine Nakhla)
"[I am] surprised that it never crossed my desk or computer screen," he said, agreeing that the lack of awareness is potentially a problem.
In his region, multiple generations often support young families and he worries about grandparents buying teething gels they used for their children decades ago without realizing that they are no longer meant for babies.
At a recent playgroup in Ottawa, parents were surprised to hear that the teething gels were no longer available.
Jenn Akeson, a mother of two, said her 17-month-old daughter had been "tossing and turning" from teething until midnight the night before. Her family doctor had told her not to use teething gels, but she didn't know the reason for this warning. She uses natural ways to soothe her daughter's teething pain, like giving her frozen fruit to chew on. But, she said, "sometimes it isn't enough."
For its part, Health Canada would only say that two Baby Orajel products were "voluntarily recalled" in May 2018 and would not discuss other products, saying it "could not comment on product availability as that is a marketing decision by the manufacturer." The department's statement said 140 benzocaine-containing natural health products and three non-prescription drugs continue to be approved for sale in Canada.
Dickinson said that medications and other products are usually not needed for infant teething. He says that if babies start drooling, chewing, or showing other signs of teething, parents can offer them a wet facecloth that has been cooled in the freezer or can give them a rubber teething ring that is meant for that purpose. Parents can also rub their babies' gums.
For the child with occasional trouble sleeping while teething, a dose of an analgesic, such as acetaminophen, can be useful, said Dr. Mike Dickinson. (Submitted by Mike Dickinson)
He said the occasional child will have trouble sleeping while teething, and a dose of an analgesic, such as acetaminophen, can be useful. But parents should avoid products that contain alcohol or an anesthetic like benzocaine, as these are potentially toxic for children.
Orajel's benzocaine-containing infant teething gels have been replaced on Canadian pharmacy shelves by homeopathic remedies, some of which contain alcohol.
"Teething is not as big a deal as sometimes it's made out to be and the vast majority of kids sail through the teething period with very mild to no symptoms," says Dickinson.
1 Michelle Ward is a pediatrician, associate professor of pediatrics and journalist in Ottawa.
