The inconsistencies in belladonna levels found in homeopathic teething products continue to put babies at risk.
Late last year, the FDA began investigating inconsistent levels of belladonna – also known as nightshade – in homeopathic remedies for infant teething pain. As a homeopathic remedy, these so called ‘natural’ products are not subject to FDA verification or regulation. They are not tested for safety before being unleashed on an unwitting public and any test results that are released about products come from the company’s own internal test procedures.
The results of these policies, as one can guess, have been less than reassuring. To be used safely, nightshade must be diluted to nearly undetectable levels. Yet, tests carried out on homeopathic teething rings showed varying levels of nightshade across test samples. This illustrates a complete lack of consistency – something that is unacceptable and intolerable when working with a substance that can kill.
New findings published by the FDA indicate that homeopathic teething tablets from Standard Homeopathic Company, the manufacturer of Hyland’s homeopathic teething products, contain wide variances in the amount of belladonna present in each tablet. In some cases, these amounts can be much, much greater than the amounts shown on the product label.
FDA officials spoke with Standard Homeopathic Company representatives and suggested a recall of Hyland’s homeopathic teething tablets, given the risks that these products pose to infants. The agency is already investigating 10 infant deaths and over 400 instances of other harm caused by teething products containing too much belladonna. These babies have suffered seizures, fevers, and vomiting as the result of ingesting a toxic substance. Removing that danger from the market seemed like a logical next step.
Standard Homeopathic Company disagreed. As of this writing, they have refused FDA requests for a recall of Hyland’s homeopathic tablets.
Thankfully, other companies have been more aggressive in their duty to keep customers and their babies safe. Raritan Pharmaceuticals, for example, pulled three of their homeopathic products off shelves in November of 2016 when excessive belladonna levels were brought to their attention.
Absent a recall put in place by Standard Homeopathic Company, the FDA can only hope that parents get word of the potentially dangerous levels of nightshade they may be giving to their babies and dispose of the products themselves. In addition to the symptoms listed above, other signs of belladonna or nightshade poisoning include difficulty breathing, lethargy, excessive sleepiness, weakness, flushed skin, constipation, difficulty with urination, or agitation.
If you notice any of these symptoms in your baby after giving them a homeopathic teething product you should contact your medical provider immediately. Healthcare providers and patients are also encouraged to use the FDA’s MedWatch program to submit a report directly to the agency. The FDA has requested that anyone who has purchased Hyland’s homeopathic teething relief products dispose of those products immediately.