A little over a month ago the United States Food and Drug Administration (FDA) issued an advisory to parents to stop using and immediately dispose of any homeopathic teething aides or gels they may have in their homes or may be using. The most popular of the brands that falls under this umbrella are Hylands Teething Tablets.
We received a number of questions from readers about the recall, and while we were able to independently find several references in the medical literature of seizures and death resulting from belladonna poisoning as a result of using the tablets as directed, the FDA’s advisory left many parents with questions. We’ve covered the issues with products marketed as homeopathic remedies previously, but like others we needed more information about what specifically prompted the FDA’s advisory about Hyland’s Teething Tablets. For that we reached out to the FDA directly. We spoke with Lyndsay Meyer who works in communications at the FDA and also happens to be the mother of a four-year-old boy.
Due to the nature of the FDA’s investigation, which is ongoing, Lyndsay was limited in what information she could provide.
Can you provide a little more information about what prompted the September 30 advisory?
On Sept. 9, the FDA received a comprehensive report of a recent adverse event of a child having a seizure associated with use of a homeopathic teething product, which triggered an agency investigation.
At this time, the FDA is still conducting our investigation, and we have not yet completed the analyses of products to determine if there is an association between the adverse events and the homeopathic teething products.
It is important to note that while adverse event reports give us some information about a product and serious injuries or deaths related to 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.
The FDA’s September 30 advisory didn’t offer much information about the nature, frequency and severity of the adverse events associated with the use of the teething tablets, what symptoms should parents be aware of?
The FDA issued the warning following this report and because further examination showed 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, and irritability.
We are also aware of reports of 10 deaths during [the time period reviewed in the report] 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.
The FDA previously recalled the tablets in 2010, is the 2016 advisory related to the issues reported in 2010 or are these new issues?
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.
What, if any products, can parents use to help manage teething discomfort?
There are more theories about teething and “treating” a baby’s sore gums than there are teeth in a child’s mouth. One thing doctors and other health care professionals agree on is that teething is a normal part of childhood that can be treated without prescription or over-the-counter (OTC) medications.
If your child’s gums are swollen and tender,
- gently rub or massage the gums with your finger, and
- give your child a cool teething ring or a clean, wet, cool washcloth to chew on.
Chill the teething ring or washcloth in the refrigerator for a short time, making sure it’s cool—not cold like an ice cube. If the object is too cold, it can hurt the gums and your child. The coolness soothes the gums by dulling the nerves, which transmit pain.
Parents should supervise their children so they don’t accidentally choke on the teething ring or wash cloth.