FDA News

FDA warns against use of homeopathic teething tablets, gels

The FDA has issued a safety alert that homeopathic teething tablets and gels may present a health risk for infants and children.

The alert also recommended that consumers stop using these products or dispose of any currently in their possession.

Janet Woodcock
Janet Woodcock

“Teething can be managed without prescription or over-the-counter remedies,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their healthcare professional for safe alternatives.”

Homeopathic teething remedies have not been evaluated or approved by the FDA for safety and efficacy, and the agency is currently analyzing reported adverse events, including seizures in infants and children who were given these products, following a 2010 safety alert about homeopathic teething tablets.

According to the FDA, consumers who have purchased homeopathic teething tablets and gels distributed by CVS, Hyland’s and possibly other retail stores should seek immediate medical attention if their child experiences seizures, trouble breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation after use.

The FDA has asked health care professionals and patients to report adverse events or side effects related to the use of teething tablets and gels to the agency’s MedWatch Safety Information and Adverse Event Reporting program at www.fda.gov/MedWatch/report.

The FDA has issued a safety alert that homeopathic teething tablets and gels may present a health risk for infants and children.

The alert also recommended that consumers stop using these products or dispose of any currently in their possession.

Janet Woodcock
Janet Woodcock

“Teething can be managed without prescription or over-the-counter remedies,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their healthcare professional for safe alternatives.”

Homeopathic teething remedies have not been evaluated or approved by the FDA for safety and efficacy, and the agency is currently analyzing reported adverse events, including seizures in infants and children who were given these products, following a 2010 safety alert about homeopathic teething tablets.

According to the FDA, consumers who have purchased homeopathic teething tablets and gels distributed by CVS, Hyland’s and possibly other retail stores should seek immediate medical attention if their child experiences seizures, trouble breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation after use.

The FDA has asked health care professionals and patients to report adverse events or side effects related to the use of teething tablets and gels to the agency’s MedWatch Safety Information and Adverse Event Reporting program at www.fda.gov/MedWatch/report.