Hyland's Teething Tablets, a homeopathic product aimed at relieving symptoms linked to teething contain inconsistent quantities of belladonna, which can be harmful to humans in high doses, the FDA (Food and Drug Administration) reports. The makers are issuing a recall. People who have bought this product are warned not to use them, and to get rid of them.
During the manufacturing process, small quantities of belladonna are added to Hyland's Teething Tablets. However, large doses of belladonna can be toxic and cause serious harm. Hence, any tablet or medication containing belladonna needs to be very carefully controlled to make sure the doses are accurate.
FDA laboratories found that Hyland's Teething Tablets do not contain consistent belladonna doses.
The FDA informs that there have been reports of adverse events in children which are linked to belladonna toxicity. Some reports received also describe incidences of children consuming too many tablets because the container caps are not child resistant.
Signs and symptoms related to belladonna toxicity include:
- breathing difficulties
- flushing of the skin
- listlessness, lethargy, fatigue
- muscle weakness
- problems urinating
- sleeping too much
The FDA adds that parts of the manufacturing operation in the Standard Homeopathic Company have been found to be "substandard". A manufacturing inspection is currently underway.
Health care professionals and lay people who witness side effects after Hyland's Teething Tablet use are encourage to report details online at www.fda.gov/MedWatch/report.htm, or call the following telephone number and request a reporting form, 1-800-332-1088.
According to the Standard Homeopathic Company, the makers of Hyland's Teething Tablets:
Belladonna is included in the Tablets to ease the redness, inflammation and discomfort of the child's gum that often occurs during the teething process.
.. Hyland's Teething Tablets contain homeopathically prepared forms of Calcarea Phosphorica, Chamomilla, Coffea Cruda, and Belladonna. These ingredients are all prepared in accordance with the Homeopathic Pharmacopoeia of the United States (HPUS).
HPUS has been recognized by the FDA since 1938 as the official compendium for homeopathic medicine in the U.S.
Source: FDA, Standard Homeopathic Company
Written by Christian Nordqvist