Login
Subscribe
February 3, 2017
Here’s an important alert for parents and caregivers with teething infants:
On Jan. 27, 2017, the Food and Drug Administration (FDA) issued a safety alert announcing that the agency has found high amounts of belladonna, a toxic substance, in certain homeopathic infant teething tablets.[1] In some cases, these amounts far exceed the amounts stated on the products’ labels.
The products are sold under the name Hyland’s homeopathic teething products. The FDA has...
February 3, 2017
Here’s an important alert for parents and caregivers with teething infants:
On Jan. 27, 2017, the Food and Drug Administration (FDA) issued a safety alert announcing that the agency has found high amounts of belladonna, a toxic substance, in certain homeopathic infant teething tablets.[1] In some cases, these amounts far exceed the amounts stated on the products’ labels.
The products are sold under the name Hyland’s homeopathic teething products. The FDA has asked the products’ manufacturer, Standard Homeopathic Company in Los Angeles, to recall them, but the company has refused to do so.
Homeopathic teething products are not approved or evaluated by the FDA for safety or effectiveness. In September 2016, the FDA warned against using any of these products after the agency received reports of infants experiencing seizures and other adverse effects after being exposed to these products.[2]
In November 2016, a different company recalled belladonna-containing homeopathic teething products, some of which were marketed by CVS.
“Teething can be managed without prescription or over-the-counter remedies,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”
What You Can Do
Stop using homeopathic teething products immediately and dispose of any in your possession. Seek urgent medical care if your child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after ingesting any such product.
If your child experiences any serious drug side effects, submit an adverse event report to the FDA, either online (www.fda.gov/MedWatch/report) or by calling 1-800-332-1088 to request a paper form. To see the FDA safety alert, visit the following website: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm538687.htm.
References
[1] Food and Drug Administration. Certain homeopathic teething products: FDA warning- confirmed elevated levels of belladonna. January 27, 2017. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm538687.htm. Accessed February 2, 2017.
[2] Food and Drug Administration. FDA news release: FDA warns against the use of homeopathic teething tablets and gels. September 30, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm. Accessed February 2, 2017.
