As claimed by Hyland’s in its website, “The amount of Belladonna alkaloids in teething tablets is minuscule, especially when compared to conventional medicines that contain Belladonna alkaloids.”

This claim, however, is different from what the U.S. Food and Drug Administration (FDA) says: “For such a product (referring to Hyland’s Teething Tablets, which are being linked to serious harm due to intake of larger doses), it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, has found that Hyland’s Teething Tablets contain inconsistent amounts of belladonna. In addition, the FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.

Belladonna, which is made as a homeopathic supplement and homeopathic medicine, is also used as an ingredient in a number of medications, such as Teething tablets from Hyland’s Inc. It comes from the Belladonna plant, also known under the names devil’s cherry and deadly nightshade due to its high toxicity.

Despite being poisonous, Belladonna has medicinal properties which has allowed it to be used as a medicine since ancient times. However, it should only be used if recommended by a doctor and strictly according to a doctor’s instructions since an overdose can be fatal, especially to children.

Besides the inconsistent amounts of Belladonna that the FDA said was contained in Hyland’s Teething products, reports of adverse events that were consistent with belladonna toxicity were also received by agency. In October of 2016, reports of adverse events that included seizures, fever, and vomiting had already gone up to 400. Worse than these, however, were reports of 10 infant deaths. The FDA is currently investigating the possible connection between the adverse effects and fatalities, and use of Hyland’s teething products (including the teething gel this time).

After two warnings by the FDA to parents to stop using Hyland’s products, Hyland’s management wrote its own letter addressed to all parents, telling them that its teething products are totally safe and effective and that baby death from teething tablets has no scientific basis. Despite this firm stand on the safety of their products, however, Hyland’s has decided to discontinue distribution of its teething tablets and gel.

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