Following an FDA warning that homeopathic teething tablets and gels may pose health risks to children, a major manufacturer said it would stop selling the products in the United States.
“This decision was made in light of the recent warning,” Hyland’s says in a Tuesday letter posted on its website. “This warning has created confusion among parents and limited access to the medicines … Many retailers, because of the announcement, have chosen to stop selling homeopathic teething medicines in their stores while others have not.”
The announcement came the same day the FDA provided additional details on the Oct. 4 warning.
The FDA is aware of reports of 10 deaths in the past six years “that reference homeopathic teething products,” said spokeswoman Lyndsay Meyer. However, the relationship between the deaths and the products hasn’t yet been determined and is being reviewed.
The FDA launched an investigation into the products after receiving a Sept. 9 report of a child having a seizure associated with the teething medicines, she says.
Further investigation showed more than 400 reports of side effects during the last six years associated with the products, she says. Those included fever, shortness of breath, lethargy, constipation, vomiting, sleepiness, tremor, agitation, irritability, seizures and even death.
The FDA’s preliminary review shows the side effects are similar to those seen in 2010, when the FDA warned of belladonna toxicity associated with Hyland’s Teething Tablets, Meyer said. The agency is continuing its investigation.
Hyland’s website notes the amount of belladonna in the tablets is miniscule. The amount of belladonna alkaloids, the component sometimes associated with side effects, is thousands of times below therapeutic amounts used in some prescription anti-spasmodic medicines, the company says.
“Our first commitment is to you, the parents who trust us every day with the wellbeing of your families,” says the Tuesday letter. “Putting you in a position of having to choose who to trust in the fact of contradictory information is burdensome and undermines the FDA … we look forward to the future of homeopathic medicines as we work in partnership with the FDA.”
Homeopathic medicines are regulated as drugs by the FDA, but the agency noted in its warning earlier this month that the products are not evaluated or approved by the FDA for safety or how well they work.
The warning advised parents to stop using the products or dispose of them.