Another Homeopathic Manufacturer Cited for Belladonna in Teething Drugs

Published on September 25, 2017 by Sandy Liebhard

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.

FDA Inspectors Cite Nova Homeopathic for Lack of Quality Control, Failure to Test Drug Components

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 1^st 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:

• Failure to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products.
• Failure to conduct at least one test to verify the identity of each component of a drug product, as well as the failure to test each component for conformity with all appropriate written specifications for purity, strength, and quality.
• Failure to establish adequate written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

FDA Teething Tablets Recalls and Warnings

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:

• Difficulty breathing
• Lethargy
• Excessive sleepiness
• Muscle weakness
• Skin flushing
• Constipation
• Difficulty urinating
• Agitation
• Seizures
• Death

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:

• CVS Homeopathic Infants’ Teething Tablets
• Kids Relief Homeopathic Ear Relief Oral Liquid
• CVS Homeopathic Kids’ Ear Relief Liquid

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.