On January 27, the U.S. Food and Drug Administration (FDA) announced that inconsistent amounts of toxic belladonna had been found in certain homeopathic teething tablets, posing an unnecessary risk to infants and children.
What is Belladonna?
Belladonna is a poisonous plant native to Europe and parts of Asia that has been used as a medicine for centuries. Although widely regarded as unsafe, belladonna is frequently used as:
• A sedative
• To treat asthma and whooping cough
• As a cold and hay fever remedy
• For Parkinson’s disease
• To relieve colic and motion sickness
• As a painkiller.
Belladonna is also used in certain homeopathic teething tablets, sometimes far in excess of the amount claimed on the label.
Homeopathic Teething Products Not FDA-Approved
Homeopathic teething products have not been evaluated or approved by the FDA for safety and effectiveness, and the agency is unaware of a proven health benefit from using them, although their labeling reflects an ability to relieve teething symptoms in babies and young children.
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. “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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
Hyland’s Refuses to Issue Recall
In light of laboratory findings, the FDA contacted the manufacturer of Hyland’s homeopathic teething products, Standard Homeopathic Company in Los Angeles regarding a recall of its products known to contain belladonna. According to the FDA, the company failed to agree to a recall, although the FDA recommends that consumers stop using and dispose of Hyland’s teething tablets immediately.
In September 2016, the FDA first issued warnings against the use of homeopathic teething products after receiving numerous adverse event reports. In November 2016, Raritan Pharmaceuticals recalled three homeopathic products containing belladonna, two of which were marketed by CVS.