Concerns about the risk of Belladonna poisoning from Hyland’s Teething Tablets has resulted in a complete recall for the hemopathic baby product, following a decision by the manufacturer last year to remove the product from store shelves.
The Hyland’s Baby Teething Tablets recall was announced by the FDA on April 13, following at least 10 deaths and hundreds of adverse events that are suspected of being linked to these and similar products.
The national recall involves Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets, impacting all lots. The homepathic teething remedues were found to contain inconsistent amounts of belladonna alkaloids, with the amounts listed on product labels differing from the actual calculated amount of belladonna in the product.
Belladonna can be toxic to humans in large doses. Unregulated amounts of the plant based ingredient may put a child at risk, especially if they are given more than recommended. Side effects could include depressed levels of consciousness, seizures, difficulty breathing, sleepiness, muscle weakness, constipation, difficulty urinating and agitation.
“There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it,” the FDA warned.
The same teething tablet products were recalled in 2010, after the FDA received adverse event reports associated with the tablets.
Homeopathic products work on the principle that exposing users to certain natural treatments can act as a remedy for certain symptoms and diseases.
Hyland’s Teething Tablets are marketed for the temporary relief of teething symptoms in infants. Many parents swore by the products, however the FDA said belladonna is a serious threat because effects are often unpredictable.
In October 2016, Standard Homeopathic Company made an announcement indicating it would stop shipping all homeopathic teething tablets for children. The company said the announcement to remove the products from the market was prompted by a safety warning issued by the FDA earlier that month.
The new recall ensures the removal of remaining stock of the teething products on store shelves. No other Standard Homeopathic Company products are affected by the recall.
“We initiated this recall even after discontinuing production last fall because it is appropriate to do what our regulating agency has formally requested,” said J.P. Borneman, PhD, chairman and CEO of Standard Homeopathic Company.
Despite the move by the company last year, the FDA issued a new warning in January, indicating the products tested positive for excessive levels of belladonna. This was prompted by the agency’s investigation of 10 deaths and hundreds of adverse events reported over the last six years.
Investigators suspect the incidents were linked to homeopathic teething tablets, however the probems have not been proven to be connected to the products. The FDA said the new warning was also prompted by the company’s failure to pull all remaining product from store shelves. This is why the new recall was issued last week.
The company is notifying distributors and retailers by mail and arranging for the return of all the products. Customers who have any Hyland’s Teething Tablets should throw away the products without using them.
Any side effects related to the use of Hyland’s Teething Tablets should be reported to the FDA via the MedWatch Adverse Event reporting program.