CHARLESTON, SC (WCSC) - The U.S. Food and Drug Administration announced Friday that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label.
The homeopathic teething tablets in question are those from Hyland's. The investigation of the company's teething medicine has been open since 2016.
Belladonna is a drug used in the tablets to ease the redness, inflammation and discomfort of the child's gum that often occurs during the teething process, according to Hyland's.
Hyland's posted this letter to their website in October of 2016:
"Dear Moms and Dads,
For generations, we at Hyland's have been proud to offer safe, effective and natural health solutions to families like yours. In fact, for over 90 years, parents have trusted Hyland's teething medicines to ease the pain of teething in infants. We thank you for that longstanding trust.
It is therefore with much sadness that we share with you that we have chosen to discontinue the distribution of our Hyland's teething medicines in the United States. This decision was made in light of the recent warning issued by the Food & Drug Administration (FDA) against the use of homeopathic teething tablets and gels. This warning has created confusion among parents and limited access to the medicines.
Our first commitment is to you, the parents who trust us every day with the wellbeing of your families. Putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA. We are committed to supporting you with quality homeopathic medicines as you tackle the incredibly challenging – and rewarding – role of raising your children.
Many retailers, because of the announcement, have chosen to stop selling homeopathic teething medicines in their stores while others have not. We are confident that any available Hyland's teething products, including those you already have, are safe for use. Of course, parents who may have concerns should consult with their physicians before using any medicines, read labels carefully and follow all instructions.
For over 100 years, we have dedicated ourselves to providing families like yours and ours with the peace of mind that comes from having the choice of safe, gentle and reliable homeopathic medicines. We are proud of our heritage and expertise in the manufacture and distribution of quality FDA-regulated homeopathic medicines. As such, we look forward to the future of homeopathic medicines as we work in partnership with the FDA. We are committed to setting the highest standards when it comes to caring for your children and grandchildren – and for our own. It's the foundation of this company. It's why we come to work every day. Thank you for letting Hyland's be part of your families.
With sincere appreciation,
The Hyland's Team of Employees"
The FDA is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.
The FDA contacted Standard Homeopathic Company in Los Angeles, the manufacturer of Hyland's homeopathic teething products, regarding a recall of its homeopathic teething tablet products labeled as containing belladonna, in order to protect consumers from inconsistent levels of belladonna. At this time, the company has not agreed to conduct a recall.
The FDA recommends that consumers stop using these products marketed by Hyland's immediately and dispose of any in their possession.
"The body's response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives."
The FDA said consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething products.