The manufacturers of an infant teething tablet have recalled the product due to the possibility of belladonna toxicity. Belladonna is commonly known as Deadly Nightshade, and is a plant whose leaves and berries are extremely toxic. Historically, belladonna has been used as both a poison and a medicine.
Hyland’s Teething Tablets are manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled.
U.S. Food and Drug Administration laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna. In addition, the FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.
The FDA recommends that consumers not use this product and dispose of any in their possession. The manufacturer is issuing a recall of this product.
The FDA advises consumers to consult their health care professional if their child experiences symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using Hyland’s Teething Tablets.
Hyland’s Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter in retail outlets. The FDA has not evaluated Hyland’s Teething Tablets for safety or efficacy, and is not aware of any proven clinical benefit offered by the product.
Health care professionals and consumers should report side effects from use of Hyland’s teething tablets to FDA through the MedWatch program, by phone at 1-800-332-1088, or online at http://www.fda.gov/medwatch/index.html.
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