The U.S. Food and Drug Administration (FDA) issued a warning for Hyland’s Teething Tablets, saying they may pose a risk to children. The manufacturer, Standard Homeopathic Company, has agreed to a recall of Hyland’s Teething Tablets.
The product is a combination of homeopathic remedies “for the temporary relief of symptoms of simple restlessness and wakeful irritability due to cutting teeth,” according to Hyland’s website.
Available in bottles of 125 quick-dissolving tablets, the formula includes calcarea phosphorica to support dentition, chamomilla for irritability, coffea cruda for wakefulness and diuresis, and belladonna (0.0003% alkaloids) for redness and inflammation—all in a lactose or milk sugar base.
The small amount of belladonna, a toxin that can cause serious harm in large doses, is at the centre of the recall since the FDA laboratory analysis found the levels were inconsistent in the product.
It had also received reports of adverse affects in children, such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation
According to Hyland’s, the drug has been on the market since 1945. The company defended the medicine stating the tablets contained only 0.2 micrograms of the toxic alkaloids of belladonna, and that around 1,000 tablets would have to be ingested before a 5 kg baby would feel any ill effects.
The company has issued a voluntary recall of the product in order to address their manufacturing process. Homeopathic medicine is unregulated in the U.S. The FDA is urging both health care professionals and consumers to report side effects.