The US Food & Drug Administration has cautioned parents to stop using homeopathic teething products in babies. Over the last five years, the federal agency has received over 400 reports of severe side effects in infants treated with homeopathic teething tablets and gels. At least 10 child deaths have been linked to the products, along with symptoms like seizures and difficulty breathing.
Homeopathic Teething Tablets & Gels May Cause Seizures
Homeopathic teething products are manufactured and marketed by a number of companies, including Hyland’s Homeopathic, Orajel and CVS – but it’s unlikely that caregivers will be able to find the tablets and gels in stores anymore. In response to the FDA’s warnings, Hyland’s Homeopathic has discontinued distribution of its infant teething products. CVS and Walgreens, the nation’s largest pharmacy chains, have pulled teething tablets and gels from store shelves.
No recalls have yet been issued. The FDA does not have the regulatory authority to recall homeopathic products of its own accord, the New York Times reports. Hyland, one of the nation’s largest manufacturers of homeopathic remedies, continues to stand behind the safety of its teething tablets and gels. In a recent press release, the company wrote:
“Our Baby Teething Tablets, like all Hyland’s branded homeopathic medicines, are made in facilities that follow current Good Manufacturing Practices and are inspected by the FDA in the same way as other OTC drugs are. You may use them with confidence.”
The FDA has taken a different position on the issue, warning caregivers in no uncertain terms to discontinue the use of teething tablets and gels immediately. Teething pain and discomfort can be adequately managed without the use of prescriptions or over-the-counter products, says Lyndsay Meyer, an FDA spokesperson.
Reported Side Effects “Consistent” With Belladonna Toxicity
The association between these injuries and homeopathic teething products has not yet been confirmed. However, government researchers say that many of the reports are consistent with belladonna poisoning. Belladonna is an extremely-toxic plant, a favored method of execution during the Middle Ages – and the active ingredient in homeopathic teething tablets and gels.
Belladonna can be extremely poisonous, especially in children. The plant’s leaves and berries contain several “anticholinergic” chemicals, which shut down the body’s parasympathetic nervous system and inhibit basic body functions like respiration, circulation and digestion. The symptoms of acute belladonna poisoning include:
- dry mouth
- difficulty breathing
- excessive sleepiness
- agitation and disorientation
- muscle weakness
These symptoms are strikingly similar to those reported in children who were treated with homeopathic teething products. “While the investigation is still ongoing, our preliminary analysis of the adverse events was enough evidence for us to warn consumers not to use these products,” FDA spokesperson Meyer told reporters at the New York Times. She says product testing is currently underway, though there’s no timeline for further updates.
Hyland’s Products Recalled In 2010
To anyone familiar with homeopathic remedies, this may all sound familiar. The FDA raised similar concerns about the safety of Hyland’s Teething Tablets in 2010, after receiving reports of infants experiencing seizures, difficulty breathing and muscle weakness. In fact, the company was placed under federal investigation – an inquiry that found “inconsistent amounts of belladonna” in Hyland’s products and “substandard control of the manufacturing process” at Hyland’s production facility.
After consulting with FDA regulators, Hyland issued a voluntary recall of its Teething Tablets. Soon after, another company, Humphreys, discontinued its own line of homeopathic teething strips and pellets. Today, the products are still listed as “temporarily unavailable” on Humphreys’ website. As for Hyland’s Teething Tablets, the product was “reformulated” and placed back on the market in 2011.
Belladonna Content “Decreased,” But Child Injuries Continue
After “reformulating” its Teething Tablets, Hyland’s Homeopathic assured parents that every precaution had been taken to protect child safety. In a press release reported by Snopes.com, the company said that “significant changes” had been made to the manufacturing process, including the introduction of “rigorous testing protocols.”
Moreover, Hyland chose to reduce the amount of belladonna in its Teething Tablets, a measure that the company said would provide “an even wider margin of safety” and actually increase the medication’s “effectiveness.” Homeopathy is in part based on the principle – completely unfounded by scientific evidence – that a remedy’s efficacy increases as the dosage of an active ingredient decreases. In fact, many homeopathic remedies are simply water, without any active ingredient at all. According to the National Institutes of Health, several of homeopathy’s key principles violate “fundamental concepts of chemistry and physics.”
It should be noted that parents have sued Hyland’s Homeopathic on several occasions over allegations that the company misrepresents the effectiveness of its medications. The company has also been cited by the FDA for misbranding its over-the-counter remedies in violation of federal law. Now, government health officials are again warning parents to stop using homeopathic teething products.
Along with products manufactured by Orajel and CVS, Hyland’s Teething Tablets and Gels have been linked to severe side effects in children. Our experienced attorneys believe that some families may be eligible to pursue financial compensation. If your child experienced any symptoms of belladonna poisoning after being given a teething tablet or gel, legal action may be possible.
Contact our product liability lawyers today to learn more about your options. The attorneys at Banville Law offer free consultations. You can find more information at no cost and no obligation.