A Message from Alma Ramirez ~ Our Health Advocate

Teething remedy warning

From "Linda Nagel" <nagell@co.mendocino.ca.us 10/26/10 9:55 AM
To Children's Health Committee and other interested colleagues-



October 25, MedPage Today * (National) Belladonna triggers recall of teething remedy.

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 U.S. Food and Drug Administration (FDA) said October 23 that 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."

*****Source: http://www.medpagetoday.com/Pediatrics/GeneralPediatrics/22959