On September 30, 2016, the FDA warned consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA is analyzing adverse events reported to the agency since 2010 regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products. Homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly others, and are sold in retail stores and online.
In 2010 a safety alert about homeopathic teething tablets was issued. Hyland's Teething Tablets were manufactured to contain a small amount of belladonna, a substance that can cause serious harm at larger doses. For such a product, it is important that the amount of belladonna be carefully controlled. FDA laboratory analysis, however, found that Hyland’s Teething Tablets contained inconsistent amounts of belladonna. In addition, the FDA had received reports of serious adverse events in children taking this product that were consistent with belladonna toxicity. The company issued a voluntary recall.
The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.
Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.
“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”
Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives, January 2015 Report: Mothers, Infants, and Obstetrical Injuries: Labor and Delivery Liability
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, April 2013 Report: Complementary and Alternative Medicine: Practitioner Liability
For news articles regarding homeopathic teething gels see:
Nicholas Bakalar, Homeopathic Teething Gels May Pose Risks, New York Times (October 5, 2016).