FDA Confirms Toxic Belladonna Plant In Homeopathic Teething Product
The Food and Drug Administration (“FDA”) is now advising parents to not use Hyland's homeopathic teething products containing belladonna. According to a news release on January 27, 2017 the FDA stated that recent laboratory analyses “found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency 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.”
This announcement comes after the FDA issued a warning in September of 2016 advising against usage and after the homeopathic teething tablets and gels had been linked to the deaths of 10 children and 400 adverse reports. In response to the FDA’s warning, the manufacturer Hyland’s released a statement, announcing, in part:
We have seen recent reports related to issues linked to use of homeopathic teething tablets and gels. Hyland’s has not been made aware of any data that supports the claims in these reports. Our understanding is that the Food and Drug Administration’s investigation of these products is still ongoing. The fact is that we have not been made aware of any medical or statistical evidence to support a causal link between homeopathic teething tablets and adverse outcomes at this point. We continue to request any available information and statistics from the FDA.
It seems the FDA did not take Hyland’s statement lightly.
Instead of teething gels or tablets, the American Academy of Pediatrics recommends gently rubbing or massaging the child's gums with your finger and giving the child a cool (not cold) teething ring or a clean, wet, cool washcloth to chew on.
TorHoerman Law is warning any parent that has any of the following products in their home to discontinue use immediately and to consult with a doctor about an appropriate replacement for infant teething relief:
- 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 Infant's 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
If your child has experienced a seizure, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels, seek medical care immediately. TorHoerman Law is now filing teething product lawsuits on behalf of children that had serious seizures and believe it was linked to one of the above teething tablets or gels.
§ FDA Confirms Elevated Levels of Belladonna in Certain Homeopathic Teething Products. (2017, January 27) Retrieved from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm538684.htm
§ Hyland's Affirms Safety of Its Products; Still Awaiting Data Behind FDA Warning. (2016, October 12) Retrieved from https://www.hylands.com/media/press-release/hylands-affirms-safety-its-products-still-awaiting-data-behind-fda-warning
§ Homeopathic Teething Gels and Tablets. National Institutes of Health. U.S. Department of Health and Human Services (2017, January 27) Retrieved from https://nccih.nih.gov/health/teething