FDA Warning: Use of Homeopathic Teething Tablets and Gels
Published : 2016-10-06 - Updated : 2017-06-26
Author : U.S. Food and Drug Administration - Contact: fda.gov
🛈 Synopsis : FDA warns homeopathic teething tablets and gels may pose risk to infants and children and recommends consumers stop using these products.
The U.S. Food and Drug Administration is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession.
Homeopathic teething tablets and gels are distributed by CVS, Hyland's, and possibly others, and are sold in retail stores and online.
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.
"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."
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.
The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of homeopathic teething tablets or gels to the FDA's MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Related Warnings - Advisories Documents
- 1: Common Poisons: Prescription Drugs, Bath Salts, Fake Pot, Laundry Pods : Poisonings from bath salts, synthetic marijuana, rx drugs and laundry detergent pods are emerging threats to public health in the U.S..
- 2: Concern Worldwide Responds to Haiti Cholera Outbreak : Confirmed outbreak of cholera in Artibonite region of Haiti with 142 deaths reported and an estimated 1,000 people infected.
- 3: Coronavirus Pandemic: COVID-19 Updates and Statistics : Regular updates, statistics, warnings, and current information resources from the U.S. CDC regarding the new novel coronavirus, referred to as 2019 Novel Coronavirus (2019-nCoV).
- 4: ADA and COVID-19 Fraudulent Face Mask Flyers : U.S. Department Of Justice warns of inaccurate flyers and postings regarding the use of face masks and The Americans With Disabilities Act.
- 5: Food Labelled Gluten Free May Still Contain Gluten : Study finds some foods labelled gluten-free do not comply with Australian standard that requires GF-labelled foods to contain no detectable gluten.
You're reading Disabled World. Be sure to check out our homepage for further informative disability news, reviews, exclusive stories and how-tos. You can also follow Disabled World on social media sites such as Twitter, Facebook, and LinkedIn.
Disclaimer: Disabled World provides general information only. Materials presented are in no way meant to be a substitute for professional medical care by a qualified practitioner, nor should they be construed as such. Any 3rd party offering or advertising on disabled-world.com does not constitute endorsement by Disabled World. View our Advertising Policy for further information. Please report outdated or inaccurate information to us.
Journal: Disabled World. Language: English (U.S.). Author: U.S. Food and Drug Administration. Electronic Publication Date: 2016-10-06 - Revised: 2017-06-26. Title: FDA Warning: Use of Homeopathic Teething Tablets and Gels, Source: <a href=https://www.disabled-world.com/disability/emergency/advisories/teething.php>FDA Warning: Use of Homeopathic Teething Tablets and Gels</a>. Retrieved 2021-04-12, from https://www.disabled-world.com/disability/emergency/advisories/teething.php - Reference: DW#445-12405.