The Food and Drug Administration Office (FDA) issued a report this Friday that states that there is a presence of toxic substances in several homeopathic teething products.
According to the official press release from the FDA, there are inconsistent amounts of a substance called belladonna in certain homeopathic tablets, and in some cases, with amounts that exceed the one that is specified on the label of the product. This finding was discovered after exhaustive analysis done in the FDA laboratories.
The recommendation from the federal agency is for people not to consume these products since they represent an unnecessary and dangerous risk, especially to infants and children.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. ”We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”
FDA warnings and its contact with the manufacturer of the products
After all the laboratory tests that showed the high amounts of belladonna in certain teething products, the FDA made contact with Standard Homeopathic Company in Los Angeles, which is the company responsible for Hyland’s homeopathic teething tablets.
The federal agency asked the company for a recall regarding the labeling of their products, in order for those products to actually show the right amount of belladonna. However, to this date, the company has not responded and has not conducted any recall. Because of this, the FDA is recommending people not to acquire any of the products of the company.
The Standard Homeopathic Company discontinued its teething products in October of 2016. According to Mary C. Borneman, a spokeswoman for Hyland’s, they didn’t want to put parents in a place between an FDA warning and the company saying that the product was safe and then deciding who to trust.
The first warning from the federal agency came in 2010 when they issued a safety alert regarding some of Hyland’s products and its inconsistent amounts of belladonna. Since that opportunity, the FDA has received almost 500 reports of complications in patients that are linked directly to the consumption of the homeopathic products that contain belladonna.
Lyndsay Meyer, a spokeswoman for the FDA, stated that most of the reports consist of serious adverse events like seizure episodes. In fact, Meyer noted, there has been over ten deaths reported during the consumption of homeopathic products. However, the direct relation between these products and the deaths is not confirmed, as the cases are currently under revision.
Later, in September, the FDA issued a second warning that consisted, again, on the dangerous amounts of belladonna present in certain teething tablets. Even when Hyland discontinued the product one month after, they still published an article on their website claiming that their products were safe.
“Our understanding is that the Food and Drug Administration’s investigation of these products is still ongoing. The fact is that we have not been made aware of any medical or statistical evidence to support a causal link between homeopathic teething tablets and adverse outcomes at this point. We continue to request any available information and statistics from the FDA,” the company wrote on its official website.
According to the company, the FDA never asked for recall and therefore they never refused to do it. The company stated that the agency’s results “remained within the documented margin of safety,” as the samples and data presented are limited when it comes to affirming the inconsistency in the teething products.
Back in November of last year, a similar case happened with a company from East Brunswick, New Jersey. The company, called Raritan Pharmaceuticals, recalled three homeopathic products that contained belladonna, and even two of those products were marketed by CVS.
Homeopathic products and its tradition
The Homeopathic teething tablets are commonly known as a medicine that helps kids on the pain that mean the growing of their first teeth. According to Borneman, the Hyland’s spokesperson, that company has over 114 years of tradition in the United States, as families around the country are at the core of what they do.
However, the Mayo Clinic has a body of recommendations that could substitute the regular homeopathic treatment. For example, parents could rub the child’s gums, change the kid’s diet regime or apply a cold washcloth.
The homeopathic products are often made from “natural ingredients” such as chamomile, Calcarea carbonica, and the polemic belladonna. This last ingredient’s effect on children below two-years-old when they consume it is yet to be proven. However, Meyer from the FDA stated that is an unnecessary risk to kids the usage of this kind of products, as they can be harmful.
Neither the FDA or any health organization has proven the real and scientific effectiveness of the homeopathic products, and even the American Academy of Pediatrics has recommended stopping the consumption of these teething products.
Source: FDA