Homeopathic Teething Tablets Recalled Due to Possible Belladonna Toxicity in Children

On Oct. 23, 2010, the Food and Drug Administration (FDA) warned consumers to stop using and discard any Hyland’s Teething Tablets in their possession. The FDA also ordered the manufacturer, Hyland’s Inc. to withdraw the tablets from the market.

Hyland’s Inc. promoted the tablets for temporary relief of teething symptoms in children. The tablets are homeopathic products that contain the potentially toxic plant belladonna (commonly known as Deadly Nightshade). It is a plant with extremely toxic leaves and berries, and it has a long history as both a poison and a medicine.

The grounds for the FDA warning and ban of Hyland’s Teething Tablets was the result of analysis and testing by the agency, which identified some tablets containing varying amounts of belladonna. The FDA has received reports of serious adverse events in children taking this product that are consistent with belladonna toxicity. The agency’s ongoing inspection of the manufacturer indicates that Hyland’s has poor control over its processes of manufacturing the tablets. The FDA also has received reports of children consuming more Hyland’s Teething Tablets than recommended, because the containers do not have child resistant caps.

What are symptoms of belladonna toxicity or overdose?

Belladonna alkaloids have anticholinergic effects. Classic signs of anticholinergic toxicity include fast heart rate, increased body temperature, dry skin, dry mouth, flushed skin, constipation, decreased urination, agitation, disorientation, hallucination and dilated pupils. Drowsiness also may be seen in infants.

Are homeopathic remedies safe?

A German physician named Samuel Hahnemann introduced homeopathy in the late 1700s. Hahnemann formulated the “Law of Similars,” which theorizes that “like cures like.” This law claims that a substance that produces a set of symptoms in a healthy person has the ability to cure an ill person who has those same symptoms, if the substance is administered in very low doses. Proponents remarkably claim that the more dilute the homeopathic preparation, the more potent the product.

We reviewed homeopathy in the October 2009 issue of Worst Pills, Best Pills News, stating, “Given the uncertainties over the actual content of homeopathic remedies and their cost, we recommend that you not use homeopathic remedies to treat symptoms or illness.”

The U.S. government officially recognizes homeopathic drugs in the Food, Drug and Cosmetic Act of 1938, but the FDA has chosen to exercise only limited regulatory authority over these products, such as authority over their manufacturing quality. However, the FDA does not evaluate homeopathic drugs for safety and efficacy, perhaps because the concentration of ingredients in these products is usually so low. To the best of our knowledge, the FDA does not inspect homeopathic drugs to determine the strength of their active ingredients before the products are sold. In fact, according to the agency, it had never evaluated Hyland’s Teething Tablets for safety or efficacy and was not aware of any proven clinical benefit offered by the product.

The Hyland’s Teething Tablets episode illustrates what can happen when the FDA does not exercise its regulatory responsibility, and superpotent drugs enter the marketplace.

What You Can Do

You should not use Hyland’s Teething Tablets or other homeopathic remedies.

Consumers may report serious adverse events with Hyland’s Teething Tablets or other products to the FDA’s MedWatch Adverse Event Reporting program either online or by regular mail, fax or phone.

• Online: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
• Regular mail: Use postage-paid, pre-addressed FDA form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: (800) FDA-0178
• Phone: (800) FDA-1088