370 Babies, Toddlers Got Sick After Using Teething Tablets
FDA also reviewing 8 deaths
By Evann Gastaldo,  Newser Staff
Posted Feb 22, 2017 1:09 PM CST
The Hyland's logo is shown on a current product.   (Amazon.com)

(Newser) – A STAT investigation reveals that more than 370 infants and toddlers got sick after their parents gave them Hyland's teething tablets or gel, a homeopathic remedy the FDA has been warning about for years. Eight children died, though the FDA is still reviewing whether the products are to blame. STAT used a Freedom of Information Act Request to obtain FDA records documenting problems possibly tied to the products from 2006 to 2016, and those documents cast a light on incidents in which babies stopped breathing, had seizures, or worse. The FDA was specifically concerned with the ingredient atropa belladonna—also known as deadly nightshade. Many of the symptoms reported are consistent with belladonna toxicity; though the herb can be used in a diluted form safely, the FDA found "inconsistent" amounts in Hyland's products.

The company says that its products are safe and that the FDA has not proven a link between them and the problems. “That doesn’t mean that children don’t have a sensitivity to a product," says a spokeswoman. "There is a lot of sensitivity on kids’ parts and we have to watch carefully. It’s not something that condemns the entire product line.” It wasn't until 2010 that the FDA issued its first warning about the products, and not until September 2016 did the agency issue a more serious warning, after which Hyland's said it would stop manufacturing the products in question. The FDA doesn't oversee homeopathic products the way it does pharmaceutical products; the agency is only tasked with determining whether homeopathic products are unsafe after they're on the market. In response to the Hyland's controversy, a congresswoman has introduced a bill that would give the FDA authority to recall homeopathic products. Click for STAT's full piece.

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