Ten infants have died and 400 others have experienced adverse side effects after reportedly using homeopathic teething tablets, the US Food and Drug Administration says. In a warning issued by the U.S. federal agency on September 30, 2016, parents are urged to stop using the natural remedies immediately and call a doctor if their child has any reaction.
The products are used to soothe teething babies, but the FDA has received numerous reports that the tablets and gels have caused adverse effects such as fever, lethargy, vomiting, sleepiness, tremors, shortness of breath, irritability and agitation.
The agency is investigating the adverse events and the cases involving the deaths, as “the relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review” according to a statement.
The FDA wrote that the homeopathic teething tablets and gels are distributed by CVS, Hyland’s, and possibly other companies, and are sold in stores and online.
Hyland’s has proactively stopped distributing the products in the United States until they receive further information from the FDA on their findings.
The retailer, Walgreens, also confirmed that it has withdrawn homeopathic teething products that were subject to this FDA warning.
The FDA issued a similar warning about homeopathic teething tablets back in 2010. That investigation discovered inconsistent amounts of belladonna in some tablets, that may have caused belladonna toxicity in babies.
Belladonna is a plant and the extract from its roots and leaves is widely regarded as unsafe. However, it is is used as a sedative and as a remedy to stop coughs and asthma. It is also used for Parkinson’s disease, colic, motion sickness, and as a painkiller, according to WebMD.
The American Academy of Pediatrics’ HealthyChildren.org has warned parents to stay away from teething tablets that contain belladonna and gels with benzocaine, citing the FDA warnings and the potential side effects, Fox News reported.
Instead, the association of doctors suggest that parents massage their child’s gums with a clean finger rather than administering the tablets or gels. Or, they suggest using a solid teething ring (many are available for sale, like this one) or a clean wet washcloth cooled in the freezer.
“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 in their press release. “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.”
Please share this important information with the parents and caregivers you know!