It’s been more than 4 months since the US Food and Drug Administration, or FDA, announced that it was investigating reports of seizures (and other adverse events) in kids who had been given “homeopathic” teething tablets and teething gels. And it’s been 2 weeks since the FDA again reminded parents of the dangers of these products.
So why hasn’t one of the biggest names in “homeopathic” remedies recalled its tablets? Why did Hyland’s announce in October that it was discontinuing the sale of teething remedies in the US but has since remained steadfast in its refusal to recall them?
The problem with these products, says the FDA, is that the amount of belladonna in them is not consistent. Authentic homeopathic remedies are supposed to be made with extremely small amounts of their “active” ingredients but some of the samples the FDA tested reportedly came back with belladonna “sometimes far exceeding the amount claimed on the label”. The excess belladonna poses what the agency calls “an unnecessary risk” to babies and children who use them.
If Hyland’s or its manufacturer, Standard Homeopathic Company, does issue a recall, it won’t be their first. Back in 2010 Hyland’s Teething Tablets were recalled for exactly this same issue–inconsistent levels of belladonna. At that time the FDA also noted that some children were reportedly consuming more tablets than recommended because the bottles did not have child resistant caps.
While Hyland’s has consistently maintained that the products are safe, the FDA is urging caregivers to dispose of any homeopathic teething products they may still have on hand. The agency also urges parents to seek medical care for any child who uses the products and experiences symptoms including:
- Breathing difficulty
- Constipation or difficulty urinating
- Muscle weakness
- Skin flushing
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