The Food and Drug Administration (FDA) is warning consumers not to use certain homeopathic teething products that contain belladonna, a toxic substance.
A laboratory analysis found inconsistent amounts of belladonna in Hyland’s homeopathic teething products. The products are manufactured by Standard Homeopathic Company, which has not agreed to a recall, according to the FDA.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” FDA Center for Drug Evaluation and Research Director Janet Woodcock, M.D., said in a news release. “We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”
The alert comes just months after the FDA issued a warning and announced a recall of similar products manufactured by Raritan Pharmaceuticals and marketed by CVS.
If a child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation after using these products he or she should see a doctor immediately.
Health care professionals and patients can report adverse side effects to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or by calling 800-332-1088.
