The U.S. Food and Drug Administration (FDA) recently warned consumers and the general public that homeopathic teething tablets and gels may be dangerous and could pose significant risks to babies and children. The FDA has gone so far as to recommend that these products not be used and that they be discarded if already purchased. The products are sold under Hyland’s, CVS, and other brand names.

No FDA Evaluation for These Products

It is important for consumers to know that products described as homeopathic teething gels and tablets are not evaluated for safety or effectiveness by the FDA. These are types of products that are not considered to be medicine, and are therefore unregulated by any federal agency. The FDA has issued a warning now because it has received reports of harm caused to infants. The agency has begun investigations into the tablets and gels, including analyzing the adverse events reports and testing the products.

Homeopathic Teething Products

Homeopathy is not considered traditional medicine and is not supported by research to be effective. The idea of homeopathic medicine is to give patients very small doses of natural substances, some of which are toxic in higher doses. One potential problem with the homeopathic teething products in question may be that a toxic ingredient, belladonna, or deadly nightshade, is actually present in larger amounts that stated on the label.

This is not the first time that the homeopathic teething tablets have presented a problem. Hyland’s teething tablets were recalled in 2010 after the FDA issued a warning about their safety. The FDA had tested several samples and found that the amounts of belladonna varied. In order for the product to be safe, this ingredient must be carefully and consistently controlled.

Adverse Events

The FDA received reports of adverse events in some infants who were given the teething tablets or gel, including seizures. The symptoms have been consistent with belladonna toxicity. Parents are being urged to watch for certain signs in their babies or children that have used the tablets or gel: trouble breathing, unusual lethargy, sleepiness, flushed skin, difficulty urinating, constipation, weak muscles, agitation, or seizures. If these symptoms are seen, parents should seek medical attention for their child immediately.

Managing Teething Safely

The FDA has stated that it will continue to investigate the reports of seizures and other symptoms associated with the homeopathic teething gels and tablets and will also keep testing samples of these products. The agency hopes to issue more information in the future, but in the meantime encourages parents to seek safe alternatives to managing teething in their babies.

According to the FDA, teething does not require any prescription or even over-the-counter remedies. Parents are urged to contact their pediatricians to get advice on managing the irritability, pain, discomfort, and sleeplessness that may accompany active teething. Teething rings for chewing on and massaging the child’s gums are accepted safe remedies for easing pain and discomfort. In some cases a doctor may recommend an over-the-counter pain medication, but for most babies and toddlers, this isn’t necessary.

Currently the recommendation is to avoid using homeopathic teething products. The FDA may issue more information, but the inconsistent levels of toxic belladonna in these products are likely to be the culprit causing some babies to have seizures and other symptoms. Until more information is released, no one should give these products to babies or children.