At least 10 babies have died and 400 children have developed serious illnesses after being treated for teething pain with homeopathic remedies, federal authorities announced Wednesday.
The FDA launched an investigation on Sept. 9 when it received a "comprehensive report of a recent adverse event" of a child having a seizure after using a homeopathic teething product, said Food and Drug Administration spokeswoman Lyndsay Meyer.
Meyer stressed that the federal investigation is still underway, and no single product has been specifically implicated in the deaths and illnesses.
During the last six years, hundreds of infants have suffered a number of adverse health effects after being treated with the products in question. In addition to seizures, ailments linked to the teething products included fevers, shortness of breath, lethargy, constipation, vomiting, sleeplessness, agitation, and irritability.
The news was first reported Wednesday by BuzzFeed.
Gene Grabowski, a spokesman for Hyland's Homeopathic, which makes several teething remedies, said the reports of possible deaths and seizures were anecdotal, and data had not been made available to his company.
"They may be related to teething tablets and gels, but there is no medical or statistical evidence that we have seen to support a causal link between teething tablets and gels, and injuries to children," Grabowski said.
The FDA strongly advises parents to throw away any homeopathic teething remedies they might be using for their children.
"We're not limiting our alert to any one product," Meyer told the Inquirer. "We're making the alerts about all homeopathic teething products."
Homeopathic remedies often contain nothing but water. But several brands of the infant teething products also contain belladonna, also known as deadly nightshade. The substance is used in infinitesimally small amounts that are supposed to help ease redness and inflammation.
A previous statement issued by Hyland's on Oct. 1 said "a 10-pound child would have to accidentally ingest, all at the same time, more than a dozen bottles of 135 Baby Teething Tablets before experiencing even a dry mouth from the product." Hyland's tablets contain trace amounts of belladonna.
On Tuesday, Hyland's announced it would stop distributing its teething products in the U.S.
CVS removed all homeopathic teething remedies from its shelves on Sept. 30.
Belladonna, which means "pretty woman," is one of the world's most toxic plants. It has been used for cosmetic purposes, diluted into an eye-drop solution to cause irises to dilate and give its users seductive bedroom-eyes.
It has also been used to tip poison arrows.
The FDA does not recommend any medicinal product for teething pain. Suffering infants may have their gums massaged by an adult finger or be given a cold washcloth to chew on.
Among the products that CVS has stopped selling are:
- Baby Orajel Naturals Gel for Teething Pain, .33 oz
- Baby Orajel Naturals Gel for Teething Pain Nighttime Formula, .33 oz
- Baby Orajel Naturals Tablets for Teething Pain, 125 Count
- CVS Homeopathic Infants' Teething Tablet, 135 Count
- CVS Homeopathic Infants' Teething Liquid, .85 oz
- Hyland's Baby Nighttime Teething Tablets, 135 Count
- Hyland's Baby Teething Gel, .5 oz
- Hyland's Baby Teething Tablets, 13 Count
- Hyland's Baby Teething Tablets, 135 Count
- Hyland's Teething Gel, .33 oz