On September 30, 2016, the U.S. Food and Drug Administration warned consumers that homeopathic teething tablets and gels may pose a risk to infants and children.1 The FDA recommended that consumers stop using these products and dispose of any in their possession. Although homeopathic treatments are regulated as drugs under the Federal Food, Drug, and Cosmetic Act, the FDA does not evaluate the remedies for safety or effectiveness.2 Manufacturers of homeopathic teething gels and tablets list ingredients such as Calcarea Phosphorica, Chamomilla, Coffea Cruda, Belladonna, Calcarea Carbonica, Passiflora Incarnata, and Terebinhina.

According to the FDA, "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."

The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels since a 2010 FDA consumer safety alert on teething tablets.3 The FDA urges both health care professionals and consumers to report adverse events to the FDA’s MedWatch Adverse Event Reporting program.4

References

  1. U.S. Food and Drug Administration. FDA warns against the use of homeopathic teething tablets and gels; 2016.
  2. National Center for Complementary and Integrative Health Homeopathy. 2015.
  3. U.S. Food and Drug Administration. Hyland’s Teething Tablets may pose a risk to children; 2010.
  4. U.S. Food and Drug Administration MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 2016.

Prepared by: Center for Scientific Information, ADA Science Institute