The U.S. Food & Drug Administration (FDA) has issued a new warning letter to Nova Homeopathic, a New Mexico-based company that markets an infant teething medication laced with potentially-toxic belladonna.
The FDA letter is the third issued this year to a manufacturer of homeopathic teething remedies. Last year, the agency warned parents and caregivers not to use the medications, after teething tablets and gels had been linked to hundreds of serious injuries, including seizes and deaths.
New Mexico-based Nova Homeopathic markets an oral liquid drug called Teething Complex, which is used to treat teething pain in infants and children. As is the case with many other homeopathic teething medications, Teething Complex contains the herbal ingredient belladonna. In very small amounts, belladonna has a sedative effect. However, excessive levels of belladonna can prove toxic.
The FDA’s September 1st Warning Letter was issued in response to an inspection the agency conducted of Nova Homeopathic’s Albuquerque facility last October, at which time a number of specific violations were observed, including:
Nearly one year ago, the FDA issued a consumer alert cautioning parents and caregivers against the use of homeopathic teething medications in infants and children, after such products had been implicated in nearly 400 adverse event reports, including 10 infant deaths. According to the agency, many of the teething tablets injuries were indicative of belladonna toxicity.
“Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy,” the FDA noted. “The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.”
Complications associated with belladonna poisoning include:
The FDA’s warning prompted some retailers to remove homeopathic teething medications from their store shelves. Standard Homeopathic, which manufactures Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets, discontinued U.S. sales of those products, However the company declined to issue a teething tablets recall at that time.
In November 2016, Raritan Pharmaceuticals announced a recall of its homeopathic teething and ear pain gels, after testing suggested the products contained inconsistent levels of belladonna. Products involved in the Raritan recall include:
Standard Homeopathic finally announced a teething tablets recall for Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets in April 2017, following a formal request by the FDA.