The Federal Drug Administration has issued a blanket warning to consumers to refrain from using homeopathic teethers after receiving reports of the deaths of 10 babies who used those products.
“I can confirm we have 10 deaths associated with the use of this product… over six years, since 2010,” said FDA spokeswoman Lyndsay Meyer.
The FDA received information on Sept. 9 that a child had a seizure due to the use of a homeopathic teething product, which triggered the agency investigation that led to the discovery of more than 400 reports of adverse events, including the deaths.
“The relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review,” Meyer wrote in an email.
“Our preliminary review shows that these adverse events are similar to those observed in 2010 when the FDA warned of belladonna toxicity associated with Hyland’s Teething Tablets, when we also issued a warning to protect the public health.”
In a Sept. 30 FDA warning about the teethers, the FDA cautioned: “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 tablets or gels.”
The blanket warning impacts homeopathic teethers made by various manufacturers, such as Hyland, CVS and Oragel.
CVS pulled all of their products voluntarily off of their shelves on Sept. 30 and listed the products types they removed here.
Hyland posted online that it will stop distribution of the products in the United States: “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.”
The adverse data report, which documents the teethers’ affects, will be posted online after FDA completes an analysis.