Federal health experts are warning parents not to use homeopathic teething tablets or gels, due to the risk of serious problems they may pose for babies.
An FDA safety alert was issued September 30, indicating that homeopathic teething tablets and gels commonly used to ease pain among infants have been linked to reports of seizures and other serious side effects, which the agency is currently analyzing.
Homeopathic teething tablets and gels are marketed as natural products, and sold over-the-counter at retail stores to help relieve teething symptoms in children. The tablets are placed on a baby’s tongue to dissolve, and the homeopathic products are often a favorite among parents who want to offer their child pain relief without turning to traditional drugs and medication.
The FDA indicates that reports of problems with the teething tablets and gels suggest that there may be serious risks associated with the use. The agency is testing product samples to investigate further.
While this latest warning does not mention a specific problem or incident, in 2010, problems with Hyland’s Teething Tablets resulted in a recall, after the agency discovered that that the tablets contained varying amounts of belladonna, a potentially harmful ingredient. Belladonna is a plant with leaves and berries that can be toxic if consumed in large amounts, thus the amounts used in homeopathic products must be carefully controlled.
At that time, the FDA received reports children were taking more tablets than recommended because the product didn’t have childproof caps. An analysis also concluded the levels of belladonna in the Hyland’s products were inconsistent, posing a threat to children. Directions on the package indicate children can take two to three tablets up to four times a day.
This latest safety alert indicates that the homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The FDA is also not aware of any “proven health benefit” offered by homeopathic teething products.
The agency recommends consumers stop using the products immediately and dispose of any remaining tablets or gels.
Parents should seek medical care if a child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation after using the homeopathic teething tablets or gels.
The FDA said it will continue to keep the public updated concerning the situation as more information has become available, but did not detail any reports of incidents involving the products.
“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.”
In 2012, other baby teething products came under fire after federal health regulators warned of a risk Baby Orajel, Anbesol, Hurricane and other over-the-counter tooth pain gel products posed to children.
That warning was directed at a non-homeopathic product used to relieve pain from teething and toothache. The warning indicated benzocaine, the main ingredient, may cause children to develop a rare condition causing brain damage or death.
Parents and caregivers are warned to report adverse events from any product to the FDA’s Med Watch Program at 800-332-1088.