FDA Warns about Harmful Effects of Teething Gels and Tablets
Washington, Nov 17 (ANI): The U.S. Food and Drug Administration (FDA) is warning parents and consumers that homeopathic teething tablets and gels such as Hyland’s and those distributed by CVS can pose a risk to infants and children. It has recommended parents immediately stop using the products and throw away any in their possession. This strict warning comes as the agency is investigating 10 deaths and more than 400 reports of seizures, fever and vomiting in infants that could be connected to the used of homeopathic teething remedies. Consumers are advised that if their child experiences any seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels to seek immediate medical attention. Dental experts such as H. Peter Ku, D.D.S. PA warn that since this supplement isn’t industry regulated it is impossible to know or verify the ingredients of each tablet. Irregularities in the product are of great concern due to its contents and their potency.
In 2010, the FDA issued an initial warning about the potential harmful side effects of Hyland’s Teething Tablets after it received reports of serious adverse effects in children. One of the active ingredients in the teething tablets, belladonna, is added as a natural pain killer; however, it must be tightly controlled because at unsafe levels it can be deadly. From the 2010 investigation, the FDA found the amount of belladonna in the teething tablets was not properly diluted and was inconsistent. While the FDA stopped short of recalling the product in 2010, it did offer a stern warning and advised parents to consult with health care professionals prior to use.
In an open letter, Hyland’s stands by their product that has been used for over 90 years. However, they acknowledge the FDA warning and have decided to discontinue the distribution of their product in the United States. While they will no longer be restocking supplies in major retailers, they reaffirm the safety of the remaining products still in stores. Large retailers like CVS have already voluntarily removed these products from their shelves.
While the FDA does not regulate homeopathic treatments in the same way it does traditional pharmaceuticals, they still conduct oversight and evaluate the effectiveness and safety of the remedies. Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research issued the following statement, “Teething can be managed without prescription or over-the-counter remedies. 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 American Academy of Pediatrics is also warning parents to stay away from these products. Although these products have been used for almost a century, they are not FDA approved nor do they have any proven health benefits.