Belladonna toxicity causes recall

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Tablets sold as a homeopathic remedy for teething pain in babies have been

recalled following reports of " serious adverse events " including seizure,

difficulty breathing, and muscle weakness.

The FDA said the reports it received are " consistent with belladonna

toxicity. " The agency has also received reports of children consuming more

than the recommended dose, " because the containers do not have child

resistant caps. "

The tablets, marketed as Hyland's Teething Tablets by Standard Homeopathic

Company, are manufactured to contain a small amount of belladonna, but FDA

analysis revealed that the tablets " contain inconsistent amounts " of the

ingredient.

The over-the-counter tablets have not been evaluated by the FDA for either

safety or efficacy and the FDA said it was " not aware of any proven clinical

benefit offered by the product. "

Moreover, the agency said, its " ongoing inspection at the manufacturer also

indicates substandard control of the manufacturing operation. "

Belladonna can cause a wide-range of symptoms including seizures, difficulty

breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing,

constipation, difficulty urinating, and agitation. The agency advised

consumers and healthcare professionals to report these side effects to the

FDA's MedWatch Adverse Event Reporting program.

LINK<http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/22959?utm_content=\

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Ortiz, MS, RD

*The FRUGAL Dietitian* <http://www.thefrugaldietitian.com>

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