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Hyland's Teething Tablets: Recall - Risk of Harm to Children
AUDIENCE: Consumers, Pediatrics
ISSUE: FDA notified consumers that Hyland's Teething Tablets is being recalled because the tablets may pose a risk to children. The 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. FDA laboratory analysis has found that Hyland's Teething Tablets contain inconsistent amounts of belladonna.
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.
BACKGROUND: Hyland's Teething Tablets is a homeopathic product, intended to provide temporary relief of teething symptoms in children. It is sold over-the-counter (OTC) 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.
RECOMMENDATION: FDA recommends that consumers not use this product and dispose of any in their possession. 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA News Release, at:
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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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