FDA warns of dangers of Hyland’s homeopathic teething tablets as recall is issued

pharmafile | April 18, 2017 | News story | Manufacturing and Production, Sales and Marketing FDA, Hyland, recall 

After months of FDA warnings, Hyland has finally issued an official voluntary recall of its homeopathic teething tablets, with the US regulatory body advising parents to cease any use of the products immediately over concerns that the dangers of their contents cannot be verified.

The tablets, which contain the toxic substance belladonna, claim to work through diluted quantities of the ingredient so that it treats what it would otherwise cause if administered at a full dose. But the FDA has warned that inconsistent levels of the harmful element have been discovered in the products; verifying the safety of the products has been an impossible task, as the agency noted in its statement on the matter: “There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it.”

There have been more than 400 reports of adverse events associated with the product, with ten cases linked to deaths; these events include seizures, shortness of breath and tremors.

The FDA originally flagged these dangers in October last year, with Hyland ceasing distribution of the product, but the manufacturer would not initiate a recall on products already on the market.

“We initiated this recall even after discontinuing production last fall because it is appropriate to do what our regulating agency has formally requested,” said chairman and CEO J.P. Borneman. “We are committed to maintaining and earning the trust consumers have placed in Standard Homeopathic Company. We have worked for 114 years to build relationships with our consumers. We intend to preserve that tradition of trust.”

Matt Fellows

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