Standard Homeopathic Company has issued a recall for Hyland’s Teething Tablets after the FDA warned consumers to stop using the over-the-counter remedy for teething symptoms in children.
The Hyland’s Teething Tablets recall includes all bottles of the homeopathic product, as the FDA indicates that the tablets may pose a risk of injury for children. The FDA has received adverse event reports that may be associated with individual tablets containing varying amounts of belladonna, a potentially toxic ingredient. In addition, the FDA has received reports of children taking more tablets than recommended because the bottles do not contain child resistant caps.
Hyland’s Teething Tablets contain small amounts of belladona, which is a plant whose leaves and berries are extremely toxic at larger doses. The FDA indicates that it is extremely important that the amount of belladonna be carefully controlled, but analysis has shown that Hyland’s Teeting Tablets contain inconsistent amounts of belladonna.
Problems with Hyland’s Teething Tablets could lead to belladonna toxicity or overdose, with symptoms that may include depressed level of consciousness, seizures, difficulty breathing, lethargy, sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating and agitation.
The FDA has warned all consumers to immediately stop using recalled Hyland’s Teething Tablets. If children have experienced symptoms or side effects of Hyland’s Teething Tablet problems, parents should contact their healthcare provider and report any adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Hyland’s Teething Tablets have been used for more than 85 years, and the manufacturer indicates that they are refining their production, packaging and testing protocols. The manufacturer continues to state that Hyland’s Teething Tablets can be a safe product for infants and toddlers.
As a homeopathic product, the FDA has never evaluated and tested the efficacy or safety of Hyland’s Teething Tablets. Such products are not required to undergo FDA approval, and the regulatory agency indicates that they are not aware of any proven clinical benefit offered by Hyland’s Teething Tablets. Once a safety concern has been identified, the FDA can require the manufacturer to have the product approved.
It is unclear whether the manufacturer will be required to submit data establishing Hyland’s Teething Tablets are safe and effective before they are able to market the homeopathic product again.