Ten baby deaths are associated with the use of homeopathic teething tablets, according to an FDA statement on the adverse events sent via email:
“We are also aware of reports of 10 deaths during that time period [the last 6 years] that reference homeopathic teething products, though the relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review.”
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On Sept. 9, the FDA received a comprehensive report of a child having a seizure associated with the use of a homeopathic teething product. This triggered an agency investigation, which found more than 400 reports of adverse events associated with homeopathic teething products in the last six years. These adverse events included:
- seizure
- death
- fever
- shortness of breath
- lethargy
- constipation
- vomiting
- sleepiness
- tremor
- agitation
- irritability.
The FDA is testing products to determine the cause of these adverse events.
The FDA issued a warning dated September 30, 2016, based on its preliminary review, which found that these adverse events are similar to those observed in 2010 when the FDA issued a Consumer Safety Alert regarding belladonna toxicity associated with Hyland’s Teething Tablets. The September 30 warning reads as follows:
“The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession. Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online. 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.”
After the FDA’s warning, CVS voluntarily removed all homeopathic teething products from their stores, including the following:
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- 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
Homeopathic Teething Tablets Not Approved by the FDA
Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy, according to the FDA warning information. The FDA also noted that it “is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.”
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If your baby was harmed by one of these products, you can contact our law firm to request a free consultation with an attorney. Attorneys Fred Pritzker is our lead lawyer for cases involving children harmed by defective products.
FDA Adverse Event Information
The FDA asks that the following be noted:
“While adverse event reports give us some information about a product and serious injuries or deaths related to the use of a particular product, they often indicate situations that require additional analysis and do not constitute conclusive evidence of a problem with the product. Sometimes after further analysis, the adverse events may inform agency decisions to take regulatory action. Other times, further analysis shows that the adverse events were not attributable to a problem with the product but to other factors, such as a patient’s underlying health conditions. It also is important to note that the number of adverse events identified may fluctuate with our growing understanding of an issue, as well as through identification and elimination of duplicate reports.”