US Pharm. 2010;35(12):100.
The FDA warned consumers that Teething Tablets manufactured by Hyland may endanger children, and it recommends that consumers not use the product and dispose of any in their possession. The manufacturer is issuing a recall. The Teething Tablets contain a small amount of belladonna, which can cause serious harm in larger doses and, as a result, require careful controls. The FDA's laboratory analysis found that Hyland's Teething Tablets contain inconsistent amounts of belladonna, and the agency 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 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. The FDA has not evaluated Hyland's Teething Tablets for safety or efficacy, and it is not aware of any proven clinical benefit offered by the product.
