Hyland's Teething Tablets recalled over potentially toxic ingredient
The recall was prompted by an FDA lab analysis, which found that the amount of belladonna in the over-the-counter dissolving tablets was inconsistent. While it prevents redness and inflammation that can be caused by teething, the active ingredient can be harmful when taken in larger doses, as reports of children who ingested more tablets than recommended have shown. Containers lacking child-resistant caps, which were also reported, increase the chance of overdose.
The dosage problems are on top of evidence that belladonna toxicity can cause seizures, difficulty breathing, lethargy, muscle weakness, skin flushing and other symptoms, according to the FDA. The agency reported that an ongoing inspection at the manufacturer also indicates unsafe and substandard manufacturing practices.
Standard Homeopathic, a 107-year-old company, has denied the presence of harmful ingredients in its product and said no conclusive link between its Hyland's Teething Tablets and the adverse effects has been drawn. "We initiated this voluntary recall to ensure our consumers know that their families' safety and health are our top priorities," said Mark Phillips, Standard's president and chief pharmacist, in a statement.
The 1-grain tablets, which are sold on the Internet, in pharmacies and other retail outlets in North America, are formulated in a base of lactose (milk sugar) and melt instantly on the tongue. They have not been evaluated for safety and efficacy and the FDA says it is not aware of any proven clinical benefit they offer.
Consumers who have purchased Hyland's tablets should stop using them and call the company for a refund. Consumers who have medical concerns or questions, or want to report adverse side effects related to the use of this product, can contact the FDA's MedWatch Reporting Program by submitting a report online at www.fda.gov/MedWatch/report.htm, by fax to 1-800-FDA-0178, or by calling 1-800-332-1088 to request a form.