The company still says they’re completely safe, but you should toss them.
Hyland’s, one of the country’s leading makers of homeopathic products, is finally bowing to pressure from the Food and Drug Administration and recalling its infant teething tablets, which have been linked to severe illnesses and deaths of infants.
The FDA has been investigating the issue for years and has received reports of more than 400 cases of infant illnesses, some involving seizures, fever, and vomiting, plus 10 infant deaths. In January, the agency confirmed that the tablets contained widely inconsistent levels of the toxic substance belladonna, aka deadly nightshade. Poisoning by belladonna produces symptoms in line with those reported in the sickened infants.
Documents obtained by a Freedom of Information Act request revealed the heart-wrenching details of those cases. In one FDA report, a mother wrote: "My daughter had a seizure, lost consciousness, and stopped breathing about 30 minutes after I gave her three Hyland’s Teething Tablets... She had to receive mouth-to-mouth CPR to resume breathing and was brought to the hospital.”
Hyland's has yet to take responsibility or acknowledge the potential danger to its customers. In public statements, it has not expressed any concern for the affected infants, but has lashed out at the FDA for casting the company in a bad light and causing "confusion" for customers.
Last October, following warnings from the FDA, Hyland’s stopped distributing the tablets in the US. However, they could still be found on store shelves, peoples medicine cabinets, and online. In January, after the FDA confirmed belladonna inconsistencies, the agency urged Hyland’s to recall the rest of the products. The company balked. In a statement to Ars at the time, Hyland’s stood by their product, maintaining that it was safe, and arguing that it does “not see any action necessary.”
But this month, the FDA put its foot down. In a strongly worded letter, dated April 7, the agency demanded a recall, declaring that the products “represent a serious health hazard.” As such, “FDA action is necessary to protect the public health and welfare.”
The agency cited several violations at the facility where the product was produced, found during an inspection last September. It also cited the test results showing inconsistent levels of belladonna. “This variability in belladonna alkaloid concentrations indicates a fundamental lack of control over the content of toxic chemicals in your drugs,” the agency wrote.
Hyland’s, unsurprisingly, still holds that its products are safe. On its website, the company explained it was issuing the recall only at the FDA’s request. “It is important for you to know that all manufactured and sold teething medicines met the Company’s safety limit tests,” the company wrote.
Homeopathic medicine, a pseudoscience, is based on the erroneous ideas that “like cures like” and that extreme dilutions of a toxic substance can cure maladies. As such, Hyland’s was purposefully adding toxic belladonna to its products. However, it was supposed to be added at consistent, exceedingly small quantities. According to the FDA’s data and inspection results, that was not the case.
The FDA reminds parents that no medication is needed for teething infants. The agency urges parents to try gentle and nonlethal gum massages, cold teething rings, and wash cloths.
Full information on the recall can be found here.
