Steven Novella recently wrote a post discussing an FDA warning against the use of homeopathic teething products over safety concerns related to the possibility of toxic amounts of belladonna. He goes into the hypocrisy of the FDA regulation of homeopathic products, a topic covered numerous times here on Science-Based Medicine, as well as the misleading initial response from Hyland’s, producers of the most popular homeopathic teething remedies in the United States and Canada. There have been some updates over the past two weeks that I’ll cover in this post.

FDA reveals concerning cases of possible serious harm

belladonnaJust as the media response to the initial FDA warning announcement on September 30th was dying down, a new round of articles, like this one from CNN, were published in response to new information from the FDA. Although the data is unpublished at this time, a spokesperson from the FDA has disclosed that their investigation into adverse events related to homeopathic teething products has revealed 400 reports, including 10 deaths, since 2010. They were clear that a causal relationship between these products and the adverse events has not been proven and that the investigation is ongoing.

I also want to be very clear and point out that as proponents of scientific skepticism we must not rush to judgement regarding these new revelations. While I am certainly no fan of homeopathy, because it is abject nonsense that carries risk of both direct and indirect harm to patients without any specific benefit, there is a very real possibility that the outcomes in question had nothing to do with these products. The reports absolutely do require further investigation, in particular when considering that this exact problem has happened before in 2010.

Why we shouldn’t rush to judgement

Adverse event reporting for drugs, which homeopathic products are designated as by the FDA despite not being tested for safety or efficacy, is no different than for vaccines. Vaccines are also drugs, but they have a completely separate reporting system known as the VAERS. Both systems serve only as a guide for more directed investigation because both can be misleading or even abused by biased individuals with a self-serving agenda.

Although it is a continuous source of cerebral embogglement for me, parents frequently attribute a variety of symptoms, even significant systemic manifestations of actual illness, to teething. Seizures, vomiting, constipation, difficulty breathing, and fever appear to make up the bulk of the adverse events discovered by the FDA so far in their investigation, but I’m sure there are more. Perhaps a child was even turned into the Hulk, or at the very least Matter-Eater Lad.

Because of how common teething is, and the sad fact that hundreds of thousands of doses of homeopathic remedies are given to teething children every year, it is possible that administration was simply coincidental to the reported outcomes. Bottom line, we need to wait until the investigation is complete and published. But we have plenty of legitimate reasons to question the availability of these products.

Response from the homeopathic community

The initial response from Hyland’s to the FDA warning, as discussed in Dr. Novella’s post, was predictably to deny the link between their product and serious adverse events, and to make clear that the FDA had not actually recalled any of their products. They followed this with a press release that again trumpeted the safety of their product and even included a condescending informational video that is full of propaganda. According to the video, even doctors can make the mistake of jumping to conclusions about homeopathic belladonna. But once we learn a little bit about the science of diluting a deadly poison into non-existence, our concerns become just plain silly.

On October 11th, just prior to the publication of numerous articles mentioning the FDA revelation of possible deaths and other adverse events caused by homeopathic teething products, Hyland’s released a letter to the public from their employees, and an accompanying FAQ, announcing that they will stop distributing their teething products in the United States. It came complete with signatures of the employees and pictures of their children and grandchildren, all supposedly relieved of their suffering by Hyland’s products. In the letter, Hyland’s lamented the confusion caused by the FDA warning and the fact that some retailers have chosen to pull their products from store shelves.

This voluntary cessation of distribution only affect retail stores in the United States. Canadian parents can still purchase Hyland’s teething products and they can still be ordered online. In the UK, homeopathic products such as Hyland’s that are produced in the United States and available online are not licensed for use, and parents across the pond have been advised by their government to avoid them.

The most obnoxious response to the FDA warning, which should come as a surprise to exactly nobody, was an “ACTION ALERT” from the National Center for Homeopathy on October 17th. It’s short but full of reality-challenged misinformation, so I’ll just reproduce it here:

On September 30th, the Food and Drug Administration issued a press release warning consumers to stop using homeopathic teething tablets and gels. The sensational and dramatic headlines that followed created a public scare and led to the removal of homeopathic teething products from the shelves of stores. This was met with wide spread “anti-FDA” sentiment in social media.

The FDA later clarified that they were conducting an ongoing investigation as a response to reported serious adverse events. While the FDA’s warning about homeopathic teething preparation seems arbitrary and capricious, the media’s exaggerated fear mongering has made a bad situation worse. In fact, an FDA spokesperson told news agencies that the relationship between serious adverse events and homeopathic teething products has not yet been determined and is currently under review.

Homeopathy has a laudable and extensively documented clinical record and there are hundreds of high quality, peer-reviewed basic science, pre-clinical, and clinical studies showing its efficacy and safety. There are no studies linking homeopathically-prepared medicines and serious adverse events.

Despite these facts, groups interested in seeing homeopathy destroyed continue to hammer away at the system – making exaggerated claims that create misunderstandings about [sic] and limit consumer access.

Homeopathy is a safe, gentle, and natural system of healing that works with your body to relieve symptoms, restore itself, and improve your overall health. It has been used successfully for the last 200 years by over 250 million people worldwide. Homeopathy is growing in popularity in the United States, where homeopathic over the counter (OTC) medicines are regulated by the FDA and have been so for decades.

No studies linking homeopathy to serious adverse events? I’ll just leave this here for you to review at your leisure. About the only accurate fact in this response is the date of the FDA warning. Even worse is the fact that they link to an anti-vaccine, conspiracy laden blog post from Living Whole.

Conclusion: It’s not personal, it’s about patient safety

The FDA and supporters of science-based medicine are not out to get Hyland’s, or any proponents of homeopathic treatments for that matter. There is no personal vendetta, only the desire for patients and parents to be given legitimate information and to protect people from possible harm, especially considering the absence of any benefit from these products beyond placebo. The FDA has reason to investigate these products and to let consumers know of their concerns so that they can make informed choices.

 

 

Posted by Clay Jones

Clay Jones, M.D. is a pediatrician practicing at Newton-Wellesley Hospital in Newton, MA, and a regular contributor to the Science-Based Medicine blog. He primarily cares for healthy newborns and hospitalized children, and devotes his full time to educating pediatric residents and medical students. Dr. Jones first became aware of and interested in the incursion of pseudoscience into his chosen profession while completing his pediatric residency at Vanderbilt Children’s Hospital a decade ago. He has since focused his efforts on teaching the application of critical thinking and scientific skepticism to the practice of pediatric medicine. Dr. Jones has no conflicts of interest to disclose and no ties to the pharmaceutical industry. He can be found on Twitter as @skepticpedi and is the co-host of The Prism Podcast with fellow SBM contributor Grant Ritchey.

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