[Pedfac] FW: FDA MedWatch - Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children

Sat Oct 1 17:35:58 EDT 2016

Thought this information might be of interest to you.

From: FDA MedWatch [mailto:fda at service.govdelivery.com]
Sent: Friday, September 30, 2016 3:34 PM
To: Flaitz, Catherine
Subject: FDA MedWatch - Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children

[MedWatch logo][MedWatch - The FDA Safety Information and Adverse Event Reporting Program]

Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children

AUDIENCE: Consumer

ISSUE: The FDA is warning 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 regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. 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.

BACKGROUND: Homeopathic teething tablets and gels are distributed by CVS, Hyland's, and possibly others, and are sold in retail stores and online.

RECOMMENDATION: The FDA recommends that consumers stop using these products and dispose of any in their possession. 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

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