FDA Issues Consumer Safety Alert: Hylandâ€™s Teething Tablets may pose a risk to children
The U.S. Food and Drug Administration today is warning consumers that Hylandâ€™s Teething Tablets may pose a risk to children, according to an FDA release forwarded by Mono County Public Health Officer Richard Johnson.
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 laboratory analysis found that Hylandâ€™s Teething Tablets contain inconsistent amounts of belladonna. The FDA has also received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity, as well as . 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 this prodcut.
Hylandâ€™s Teething Tablets is a homeopathic product intended to provide temporary relief of teething symptoms in children that is sold over-the-counter (OTC) in retail outlets. The FDA has not evaluated Hylandâ€™s Teething Tablets for safety or efficacy, and is not aware of any proven clinical benefit offered by the product.
FDA urges both health care professionals and consumers to report side effects from use of Hylandâ€™s Teething Tablets to the FDAâ€™s MedWatch Adverse Event Reporting program either:
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.