Homeopathic teething products recently pulled from the market in the United States over potential health risks are still for sale in Canada, but the company that makes the products insists that they are safe.
"Hyland's baby teething medicines remain in distribution in Canada," company spokeswoman Mary Borneman said Friday in an e-mail.
"We have chosen to discontinue the product line in the U.S. because of the [U.S.] Food & Drug Administration's general warning against the use of these medicines," she wrote, adding, "We are confident the product is safe so we can continue to distribute in areas that do not have a similar warning."
On Sept. 30, the U.S. FDA warned against the use of homeopathic teething gels and tablets distributed by Hyland's, pharmacy chain CVS and "possibly others," saying the products could pose a risk to infants and children.
The products are applied to children's teeth and gums to ease teething pains. The FDA says teething can be managed without prescription or over-the-counter remedies.
In a letter to consumers on Oct. 11, Hyland's said it would no longer distribute its teething products in the U.S. as the FDA warning "has created confusion among parents and limited access to the medicines."
The FDA warning came after the agency received a "comprehensive" report of a child having a seizure associated with the use of a homeopathic teething product, FDA spokeswoman Lyndsay Meyer said in an e-mail.
That report, received in early September, triggered an FDA investigation that found more than 400 reports of adverse events, including deaths, seizures and fever, associated with homeopathic teething products over the preceding six years.
"We are also aware of reports of 10 deaths during that time period that reference homeopathic teething products, though the relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review," Ms. Meyer said.
The agency's preliminary review shows the adverse events over the past six years are similar to ones observed in 2010, when the FDA issued a public warning about belladonna toxicity associated with Hyland's teething tablets, she said.
Belladonna is a plant that has a history of medicinal use but that can be poisonous.
In a statement on its website, Hyland's says "the amount of belladonna used in Hyland's Baby Teething Tablets is miniscule" and that "a child would have to eat multiple bottles at once to experience the first side effect of belladonna, which is typically dry mouth."
Health Canada is aware of the FDA warning and is looking into the issue, Health Canada spokesman Eric Morrissette said Thursday in an e-mail.
"Parents and caregivers with questions or concerns about teething products for their children should speak to a health-care professional, such as a pharmacist," Mr. Morrisette said.
Consumers should report adverse events related to teething gels or any other licensed health product to Health Canada, he said, adding that is often not possible to confirm whether a product has caused an adverse reaction.
Health Canada has granted licences to 16 homeopathic teething products from 11 companies, including Hyland's. As of June 30 the agency was aware of only seven adverse-reaction reports with a suspected link to homeopathic teething products, which have been licensed by the agency for nearly a decade.
None of those reports involved a death. Of the seven, three were found to have been related to other causes, one resulted in hospitalization for an allergic reaction and the remaining three were "non-serious" cases of abdominal pain, rash and vomiting.
Health Canada is currently in the process of overhauling the system it uses to regulate "self-care" products, including homeopathic products, which are available without a prescription and include cosmetics and natural health products.
The new regime would classify many vitamin, mineral and homeopathic products and cosmetics as "low risk," meaning they would not be licensed by Health Canada.
Products deemed "moderate" or "higher" risk – such as over-the-counter painkillers, allergy medications and products that contain new medicinal ingredients – would be reviewed by Health Canada and could only make health claims if enough scientific evidence is presented to prove the statements.
A consultation period for those proposals ends on Oct. 24.