Years after the US Food and Drug Administration first started cautioning parents to avoid it, the manufacturer of Hyland’s Baby Nighttime Teething Tablets has issued a nationwide recall. The FDA has received reports of more than 400 cases of infant illnesses, some involving seizures, fever, and vomiting, plus 10 infant deaths involving the tablets.
The agency has concluded that the medicines contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products’ labels. The FDA’s position is that belladonna represents a serious health hazard to children and that the effects of belladonna are unpredictable. As the agency has informed the Company,
“There is no known safe dose or toxic dose of belladonna in children because of the many factors that affect it.”
J.P. Borneman, PhD, chairman and CEO of Hyland’s parent company Standard Homeopathic Company, said:
“We initiated this recall even after discontinuing production last fall because it is appropriate to do what our regulating agency has formally requested. 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.”
Belladonna, also known as deadly nightshade, is an herb plant in the Nightshade family. The foliage and berries are extremely toxic, containing tropane alkaloids. These toxins include atropine, scopolamine and hyoscyamine, which cause a bizarre delirium and hallucinations.
The plant has a long history of use as a medicine, cosmetic, and poison. Before the Middle Ages, it was used as an anesthetic for surgery; the ancient Romans used it as a poison (the wife of Emperor Augustus and the wife of Claudius both were rumored to have used it for murder); and, predating this, it was used to make poison-tipped arrows.
The genus name Atropa comes from Atropos, one of the three Fates in Greek mythology, and the name “bella donna” is derived from Italian and means “beautiful woman” because the herb was used in eye-drops by women to dilate the pupils of the eyes to make them appear seductive.
Consumers with questions regarding this recall can contact Standard Homeopathic Company by calling 1-800-991-3376 (Monday-Friday 6 a.m. to 4 p.m. Pacific Time). Consumers should contact their physician or healthcare provider if they believe they have experienced any problems that may be related to taking or using this drug product.