FDA Adverse Event Reports Detail Teething Tablets Deaths, Injuries

Published on February 22, 2017 by Sandy Liebhard

Hundreds of babies have suffered seizures and other serious complications following treatment with Hyland’s homeopathic teething products. A recent review of the U.S. Food & Drug Administration’s (FDA) adverse event database also linked the products to eight infant deaths.

The adverse event data was obtained by StatNews.com, via a Freedom of Information Act request. The reports implicated Hyland’s teething remedies in more than 370 incidents over a 10-year period, from 2006 to 2016. Some babies suffered repeated seizures, while other became delirious. In one case, a child had to be airlifted to the ER after their arms and legs started twitching.  In August 2010, one mother reported that her toddler had stopped breathing:

“My daughter had a seizure, lost consciousness, and stopped breathing about 30 minutes after I gave her three Hyland’s Teething Tablets,” she told the FDA. “She had to receive mouth-to-mouth CPR to resume breathing and was brought to the hospital.”

Eight of the reports involved children who died after ingesting Hyland’s teething products. The FDA is also investigating two other deaths that followed use of homeopathic teething remedies, but would not disclose the manufacturer involved in those cases.

Many of the adverse event reports collected by the FDA were consistent with belladonna poisoning. This herbal ingredient is used in homeopathic teething products for its sedative effect. However, belladonna can prove toxic when ingested in large amounts.

Homeopathic Teething Tablet Warnings & Recalls

Last September, the FDA warned against the use of homeopathic teething tablets and gels due to the high number of adverse events reported in relation to these remedies. Several retailers pulled the products from their store shelves in response to the warning. Hyland’s announced it would no longer market homeopathic teething products in the U.S. However, it did not recall its products, and consumers were not offered refunds.

In November, Raritan Pharmaceuticals announced a teething tablets recall, after its homeopathic remedies were found to contain inconsistent levels of belladonna. According to the FDA, those products have not yet been implicated in any injuries.

Just last month, the FDA advised consumers to discard any Hyland’s teething remedies in their possession, after testing  confirmed that they contained inconsistent amounts of potentially toxic belladonna. However, the manufacturer of the products has declined to issue a recall. A spokesperson for Hyland’s parent company told Reuters at the time that a recall was not necessary, as sales had already been discontinued.

Hyland’s did announce a teething tablets recall in 2010, after the products were linked to a number of adverse events. Those recalled  medications  were also found to contain inconsistent amounts of belladonna.