The FDA has just issued a terse and serious warning against the use of homeopathic teething tablets and gels which have gained popularity in recent years. They recommend, in fact, “that consumers stop using these products and dispose of any in their possession.”
The statement goes on: “The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples. The agency will continue to communicate with the public as more information is available.”
Homeopathic remedies, which are not considered medicines and are therefore not regulated by any government agency for quality, safety, or effectiveness, have grown in popularity as more and more real medications have been disqualified for use on very young babies. Homeopathy is defined as “the treatment of disease by minute doses of natural substances that in a healthy person would produce symptoms of disease.” In fact, no over-the-counter medications are now labeled for use on babies under the age of 6 months.
This has presented a particular problem for parents of young babies and a marketing opportunity for companies looking to cash in on a short but intense period: the time when a baby under the age of 6 months is teething. Teething can cause discomfort and irritability, and it is, conveniently for homeopathic remedy makers, notoriously hard to diagnose. While kids sprout their first tooth on average around the age of 6 months, many parents believe they are seeing signs of teething much earlier. After 6 months of age, it is safe to give a teething baby Tylenol, but before that, many parents have increasingly opted for homeopathic remedies.
It is a testament to their increasing exposure and popularity in the mainstream that CVS pharmacy is listed by name as being a distributor of the products. Though there are many manufacturers of these products, the arguably best known one is Hyland’s, which is also mentioned by name in the release. CVS has issued a voluntary withdrawal of all homeopathic teething products and removed them from shelves, including Hyland’s products, several products made by Orajel, as well as products under the CVS brand itself.
This is not the first time Hyland’s in particular has had problems: The company was the culprit of the previously mentioned 2010 safety warning issued by the FDA, in which it found “inconsistent” amounts of belladonna, which at high concentrations can be dangerous or even fatal. There were at the time reports of serious side effects from several consumers.
The FDA does not directly issue recalls on consumer products and it is generally left up to the manufacturers to do so. This new warning should be considered seriously by consumers as the products remain available for sale at many retailers at this time.