Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA Warns Against Use of Homeopathic Teething Tablets
FDA press release; 2016 Sep 30
The FDA has issued a warning against the use of homeopathic teething tablets and gels as they may pose a risk to infants and children. The FDA recommends that consumers stop using these products and dispose of any in their possession. These products are sold in retail stores and online.
The FDA says consumers should seek medical care immediately if their child experiences any of the following symptoms after using homeopathic teething tablets or gels:
- Seizures
- Difficulty breathing
- Lethargy
- Excessive sleepiness
- Muscle weakness
- Skin flushing
- Constipation
- Difficulty urinating
- Agitation
The FDA is analyzing adverse events relating to homeopathic teething tablets and gels and encourages health care professionals and consumers to report adverse events or quality problems to its MedWatch Adverse Events Reporting program.
US Food and Drug Administration. FDA warns against the use of homeopathic teething tablets and gels. FDA web site. September 30, 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm523468.htm. Accessed October 9, 2016.
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This FDA alert reminds us that untested, unregulated products with poor quality control may not be as safe as advertised. It turns out that these homeopathic teething aids contain belladonna.1 Belladonna, also known as the “deadly nightshade,” has been used throughout history as a deadly poison. Belladonna has also been used as a medicinal in tinctures to treat GI disorders, motion sickness and pain. The name belladonna comes from the Italian, Bella Donna, meaning beautiful lady, as belladonna was also used by women to dilate their pupils to enhance the attractiveness of the eyes. The main ingredients in belladonna are atropine and scopolamine, both strong anticholinergic medications.2 Symptoms of cholinergic poisoning include dilated pupils, blurred vision, tachycardia, loss of balance, dry mouth, constipation, urinary retention, delirium and seizures. The main lesson here is that physicians and our patients need to be cautious about the use of seemingly safe homeopathic products as they can contain ingredients which can be quite dangerous. —Neil Skolnik, MD
US Food and Drug Administration. FDA issues consumer safety alert. FDA web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm230761.htm. Accessed October 17, 2016.
Wikipedia Web site. Atropa belladonna at: https://en.wikipedia.org/wiki/Atropa_belladonna. Accessed October 17, 2016.