FDA Warning: Homeopathic Teething Remedies May Harm Babies

When babies experience the discomfort of teething, parents naturally seek solutions to ease their little one’s pain. However, a serious warning from the Food and Drug Administration has put certain popular teething remedies under intense scrutiny. The FDA’s investigation into homeopathic teething tablets and gels has revealed alarming connections to infant deaths and hundreds of adverse health events, prompting urgent advisories for parents and caregivers across the nation.

The agency’s warning, issued in September 2016, represents a significant escalation in concerns about these widely available products. What many parents assumed were gentle, natural remedies have been linked to seizures, breathing difficulties, and even fatalities in young children. This development has sent shockwaves through the parenting community and raised critical questions about the safety and regulation of homeopathic products marketed for infants.

The FDA’s Investigation and Findings

The Food and Drug Administration launched a comprehensive investigation after receiving disturbing reports connecting homeopathic teething products to serious health complications in infants and young children. Over a six-year period, the agency documented more than 400 adverse health events among children who used these products. These incidents ranged from relatively minor symptoms to life-threatening emergencies that required immediate medical intervention.

Most alarmingly, the FDA’s investigation identified reports of 10 children’s deaths that referenced the use of homeopathic teething medicines. While the agency cautioned that a conclusive link between the deaths and the medications had not been definitively proven at the time of the initial warning, the pattern of reports raised sufficient concern to warrant immediate action. The most recent case before the warning involved a child who experienced a seizure on September 9, 2016, after using these products.

The adverse events reported to the FDA included a range of severe symptoms that should alarm any parent. Children experienced seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, and unexplained agitation. These symptoms are consistent with belladonna toxicity, a dangerous condition that can occur when a person is exposed to excessive amounts of this plant-derived substance.

The Belladonna Problem: Understanding the Dangerous Ingredient

At the heart of the controversy surrounding homeopathic teething products lies a single ingredient: belladonna. Also known as deadly nightshade, belladonna is a plant that has been used for centuries as both a poison and a medicine. The name itself—deadly nightshade—should give parents pause about any product containing this substance being marketed for use in infants.

Homeopathic teething tablets like Hyland’s Teething Tablets were manufactured to contain what the company described as a small amount of belladonna. However, the FDA’s testing revealed a critical problem: the tablets contained inconsistent amounts of this dangerous ingredient. For products containing substances that can cause serious harm at larger doses, precise control of the ingredient amount is absolutely essential. The lack of consistency meant that some tablets could potentially contain dangerous levels of belladonna.

The FDA first raised concerns about belladonna levels in homeopathic teething products in 2010, when testing determined that Hyland’s Teething Tablets contained variable and sometimes excessive amounts of the substance. The agency noted at that time that for products containing belladonna, it is critically important that the amount be carefully controlled. This earlier warning should have served as a red flag, but the products remained on the market and continued to be used by unsuspecting parents.

Official FDA Position and Recommendations

Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research, issued a clear and unequivocal message to parents and caregivers in the September 2016 warning. Her statement emphasized that teething can be managed without prescription or over-the-counter remedies. The FDA’s official recommendation was direct: parents and caregivers should not give homeopathic teething tablets and gels to children and should seek advice from their healthcare professionals for safe alternatives.

The FDA urged consumers to stop using homeopathic teething products immediately and to dispose of them. This wasn’t merely a precautionary suggestion but an urgent safety directive based on the agency’s ongoing investigation. The warning applied to products distributed by multiple companies, including CVS, Hyland’s, and potentially others, and encompassed items sold both in retail stores and online.

Parents were advised to seek immediate medical care if their child exhibited any of the following symptoms after using teething tablets or gels: seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation. The FDA also encouraged healthcare professionals and patients to report adverse side effects through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Market Response and Product Recalls

The FDA’s warning triggered swift action from major retailers and manufacturers. CVS Pharmacy, one of the largest drug store chains in the United States, immediately removed Hyland’s products, Baby Orajel Naturals, and its own version of homeopathic teething remedies from store shelves. This decisive action by a major retailer underscored the seriousness of the FDA’s concerns and helped protect consumers from potentially dangerous products.

Hyland’s, the manufacturer of teething tablets and gels for more than 90 years, ultimately made the decision to discontinue distribution of its teething medicines in the United States. In an open letter published on its website, the company stated that the decision was made in light of the FDA warning, which had created confusion among parents and limited access to the medicines. While Hyland’s expressed confidence that any remaining products on store shelves were safe to use, the company acknowledged the burden placed on parents by contradictory information.

The company’s decision to discontinue these products represented a significant acknowledgment of the controversy, even as Hyland’s maintained its position regarding product safety. The discontinuation effectively removed these specific products from the market, though questions remained about other homeopathic teething remedies that might still be available from different manufacturers.

Understanding Homeopathic Products and Regulatory Gaps

The controversy surrounding homeopathic teething remedies highlights broader questions about how homeopathic products are regulated in the United States. Unlike conventional drugs, which must undergo rigorous testing and approval processes before reaching the market, homeopathic products have historically faced less stringent regulatory requirements. This regulatory gap has allowed products to be marketed and sold without the same level of safety verification required for traditional medications.

Many parents choose homeopathic products believing they are gentler and safer alternatives to conventional medicines. The word “homeopathic” carries connotations of natural, gentle remedies that work in harmony with the body. However, this perception can be dangerously misleading. Natural does not automatically mean safe, particularly when products contain substances like belladonna that are known toxins.

The homeopathic industry operates on principles that differ fundamentally from conventional medicine. Homeopathy is based on the concept that “like cures like” and that substances should be highly diluted to be effective. However, the FDA’s testing revealed that some homeopathic teething products contained inconsistent and sometimes dangerous levels of active ingredients, demonstrating that manufacturing processes did not always achieve the claimed dilution levels.

Other Risky Teething Remedies to Avoid

The FDA warning about homeopathic teething products is not the only caution parents need to heed when seeking teething relief for their babies. Several other popular remedies pose significant risks and should be avoided entirely.

Benzocaine Products: Over-the-counter gels and liquid benzocaine products, such as Anbesol and Orajel, are unsafe for teething babies. The FDA issued a warning in 2011 against the use of these products with children under 2 years old due to the risk of methemoglobinemia, a sometimes-fatal condition that results in a severe drop in the amount of oxygen in the bloodstream. Despite being widely available, these topical anesthetics pose serious health risks when used on young children.

Amber Teething Necklaces: Amber teething necklaces have gained popularity in recent years, sometimes sold with claims that the amber releases pain-relieving chemicals absorbed through the baby’s skin. However, there is no scientific evidence that they actually soothe pain, and they pose potential risks for both strangulation and choking. The American Academy of Pediatrics advises parents not to allow babies to wear any jewelry because of these safety concerns.

Safe and Effective Teething Alternatives

The good news for parents is that teething discomfort can be effectively managed without resorting to potentially dangerous remedies. Healthcare professionals recommend several safe approaches that can provide genuine relief for teething babies without exposing them to unnecessary risks.

Cold Therapy: Applying gentle cold to irritated gums can provide significant relief. Parents can offer a clean, cold, wet washcloth for the baby to chew on, or refrigerate (not freeze) a clean teething ring made from firm rubber. The cold helps numb the gums and reduce inflammation, providing natural pain relief without any medications.

Gentle Pressure: Massaging the baby’s gums with a clean finger can help alleviate discomfort. The counterpressure provides relief and can be done as often as needed throughout the day. This hands-on approach also provides comfort through parental touch and attention.

Age-Appropriate Pain Relief: When non-medicinal approaches are insufficient, parents can consult with their pediatrician about appropriate doses of acetaminophen or ibuprofen. These conventional pain relievers, when used as directed by a healthcare provider, are safe and effective for managing teething discomfort in infants who are old enough to take them.

Distraction and Comfort: Sometimes the best remedy is simply providing extra comfort, attention, and distraction. Engaging the baby in play, offering favorite toys, or providing additional cuddle time can help take their mind off the discomfort and provide emotional support during this challenging developmental phase.

The Importance of Consulting Healthcare Professionals

One of the key messages from the FDA warning is the importance of consulting with healthcare professionals rather than relying on over-the-counter remedies, particularly those making homeopathic claims. Pediatricians and family physicians can provide evidence-based guidance on managing teething symptoms and can help parents distinguish between normal teething discomfort and symptoms that might indicate other health issues.

Healthcare providers can assess each child’s individual situation and make appropriate recommendations based on the baby’s age, overall health, and specific symptoms. They can also help parents understand what symptoms are typical for teething and which warrant medical attention. This professional guidance is invaluable in ensuring that babies receive safe, effective care during the teething process.

Parents should not hesitate to contact their child’s healthcare provider if they have questions or concerns about teething. Medical professionals would much rather answer questions and provide reassurance than have parents use potentially dangerous products or miss signs of more serious health issues.

Recognizing the Signs of Teething

Understanding normal teething symptoms can help parents respond appropriately to their baby’s discomfort. Teething generally begins between 4 and 7 months of age, though the timing can vary considerably from one child to another. The signs of discomfort can come and go as additional teeth emerge throughout infancy and early toddlerhood.

Common teething symptoms include increased drooling, the urge to chew on objects, irritability and fussiness, swollen or tender gums, and sometimes mild temperature elevation (though high fever is not a typical teething symptom and should be evaluated by a doctor). Even the happiest babies can become temporarily irritable and fussy when their first teeth come in.

It’s important for parents to understand that while teething can cause discomfort, it should not cause severe illness. Symptoms like high fever, diarrhea, rash, or extreme lethargy are not normal teething symptoms and warrant evaluation by a healthcare provider. Attributing serious symptoms to teething can delay diagnosis and treatment of actual illnesses.

Moving Forward: Consumer Awareness and Product Safety

The FDA’s warning about homeopathic teething remedies serves as an important reminder about the need for consumer awareness and vigilance when it comes to products marketed for infants and children. Just because a product is available for sale does not guarantee its safety, and natural or homeopathic labels do not ensure that a product is free from risks.

Parents should approach health products for their children with healthy skepticism and should prioritize recommendations from qualified healthcare professionals over marketing claims. Reading labels carefully, researching products before use, and staying informed about FDA warnings and recalls are all important aspects of protecting children’s health.

The investigation into homeopathic teething products also raises broader questions about how such products should be regulated to ensure consumer safety. As the FDA continues to evaluate its approach to homeopathic drugs, parents can protect their children by choosing proven, safe methods for managing teething discomfort and consulting with healthcare providers about any concerns.

Frequently Asked Questions

Q: What should I do if I’ve already given my baby homeopathic teething tablets?

A: Stop using the product immediately and dispose of it. Monitor your baby closely for any adverse symptoms such as seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation. If any of these symptoms occur, seek immediate medical attention. Contact your pediatrician to discuss what you’ve observed and get guidance on safe alternatives for managing teething discomfort.

Q: Are all teething products dangerous?

A: No, not all teething products are dangerous, but several categories should be avoided. The FDA specifically warns against homeopathic teething tablets and gels containing belladonna, and benzocaine-containing products for children under 2 years old. Amber teething necklaces also pose strangulation and choking risks. Safe options include firm rubber teething rings (refrigerated, not frozen), cold washcloths, and gentle gum massage. Always consult your pediatrician for recommendations.

Q: Why are homeopathic products less regulated than regular medications?

A: Homeopathic products have historically been subject to different regulatory standards than conventional drugs. They have not been required to undergo the same rigorous testing and approval processes that apply to traditional medications. However, this does not mean they are inherently safer. The FDA is working to update its regulatory approach to homeopathic products, particularly those marketed for vulnerable populations like infants and children.

Q: What are the safest ways to help my teething baby?

A: The safest approaches include offering a cold, clean washcloth or refrigerated teething ring for the baby to chew on, gently massaging the gums with a clean finger, providing extra comfort and distraction, and consulting your pediatrician about appropriate doses of acetaminophen or ibuprofen if non-medicinal methods aren’t sufficient. Always avoid products containing belladonna, benzocaine, or any unproven ingredients.

Q: How can I report an adverse reaction to a teething product?

A: You can report adverse reactions to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online at www.fda.gov/MedWatch/report or by calling 800-332-1088. Healthcare professionals and consumers are both encouraged to report any adverse events, as these reports help the FDA identify potential safety issues and protect other children from harm.

Q: Is belladonna ever safe for babies?

A: Belladonna, also known as deadly nightshade, is a toxic plant that can cause serious harm, especially in infants and young children. Even small amounts can be dangerous, and the risk increases significantly when product manufacturing results in inconsistent concentrations. There are no circumstances where parents should give babies products containing belladonna without explicit direction from a qualified medical professional, and even then, safer alternatives should be strongly considered.