Weitz & Luxenberg is now accepting cases of children or infants who were injured after using homeopathic teething tablets and gels produced by Hyland’s or sold under the CVS brand.
Used by parents in an effort to reduce irritability and restlessness in teething children, as the tablet labeling suggests is a benefit, these products were found by the FDA to contain inconsistent, and in some cases elevated, amounts of belladonna, an herb also known as deadly nightshade. The FDA has received serious reports of adverse events in children and infants after ingesting these products, including death, loss of consciousness, seizures, and episodes of sleepiness, lethargy, or difficulty with or slowed breathing.
The U.S. Food & Drug Administration (FDA) issued warnings about the products in 2010 and 2016, and confirmed in January 2017 via laboratory testing that the levels of belladonna in selected samples of certain products were often much higher than indicated on labels. CVS brand teething tablets were voluntarily recalled by the manufacturer, Raritan Pharmaceuticals, in November 2016. Under pressure from the FDA, Standard Homeopathic Company, the manufacturer of Hyland’s products, issued a nationwide voluntary recall of its belladonna-containing teething tablets in April 2017.
Hyland’s Homeopathic Teething Products Claimed to Be Safe
Hyland’s Baby Natural Relief Teething Tablets, Hyland’s Baby Natural Relief Nighttime Teething Tablets, and Hyland’s Baby Teething Gel are homeopathic products whose labeled use is for relieving pain and irritability due to teething. They come in two forms: a quick-dissolve tablet or a gel topically applied to the gums.
The products were marketed by Hyland’s as safe and effective, containing “all-natural” “medicines.” Belladonna is one of the ingredients in the products and is used for its purported ability to, according to Hyland’s website, relieve “symptoms of redness and inflammation of the gums during teething.”
The company made these claims regarding the benefits of its teething tablets and gel in spite of a safety alert issued in 2010 by the FDA, and another series of safety updates issued in 2016, in which the agency stated it is “not aware of any proven health benefit of the products” while warning they may “pose a risk to infants and children” after receiving adverse event reports of serious injuries and death in children after ingestion of these products.
In a letter to the public regarding teething tablets from Hyland’s on its website, Hyland’s said that the amount of belladonna in its products was “minuscule.” The company minimized potential side effects of belladonna and directed parents to “please keep in mind that even if a child ate an entire bottle of homeopathic medicine, the minute total amount of active ingredients renders the changes of a medically serious anticholinergic toxicity effects highly unlikely.”
These statements are still on Hyland’s website in spite of the FDA’s safety announcements to the public that these belladonna-containing products may pose risks to infants and children, and confirmation via FDA laboratory analysis that these products may contain widely varying amounts of belladonna, several samples of which were higher than the amounts stated in product labeling.
FDA Issues Several Safety Warnings About Homeopathic Teething Products
Between 2006 and 2016, the FDA received reports of adverse events in more than 370 children who had been given Hyland’s teething products. In eight of these cases, the infant was reported to have died after using the product.
In one case reported to the FDA, a mother said that her daughter stopped breathing within minutes after taking three homeopathic teething pills, and subsequently had a seizure, lost consciousness, and required hospitalization.
After a 2010 FDA inspection of Hyland’s facilities revealed substandard manufacturing practices, the FDA found inconsistent ingredient levels of belladonna in the company’s products and issued a public safety warning about the homeopathic teething tablets, citing adverse events characteristic of belladonna toxicity. Standard Homeopathic Company, the manufacturer of Hyland’s products, voluntarily recalled the tablets and agreed to reformulate them after the warning.
In September 2016, after another inspection of a Standard Homeopathic Company’s facility, the FDA issued another warning to consumers stating that homeopathic teething tablets and gels could pose a health risk to infants and children, and recommended consumers discontinue use of the products. Despite this warning and a subsequent request made in April 2017 by the FDA to Standard Homeopathic to immediately initiate a recall, the company did not recall its teething tablets until April 13, 2017.
Instead in October 2016, Hyland’s announced to customers that Hyland’s would stop manufacturing and selling its teething tablets, expressing regret to consumers due to the FDA’s creating “confusion” with customers. The company did not, however, address the products already sold or those in distribution. One month later, Raritan Pharmaceuticals, some of whose belladonna-containing teething products were sold as CVS branded teething tablets, issued a voluntary nationwide recall of its teething product.
Following the recall, the FDA sent warning letters to Homeolab USA/Homeocan Inc., which manufactured homeopathic mixtures for contract manufacturer Raritan Pharmaceuticals, which also received a warning letter from the FDA, regarding “methods, facilities, or controls for manufacturing, processing, packing, or holding…” that did not conform to good manufacturing practices.
By January 2017, the FDA completed its analysis of belladonna levels in samples of homeopathic teething products and found that amounts in some far exceeded the stated levels on the product labels and were even inconsistent across tablets in the same bottle. In spite of repeated warnings and evidence presented by the FDA, Hyland’s did not take its products off shelves until April 2017, when Standard Homeopathic Company recalled all lots of Hyland’s teething tablets because of inconsistent levels of belladonna in its teething tablets.
Injuries from Belladonna in Homeopathic Teething Tablets
Reported injures in children and infants who ingested homeopathic teething products containing belladonna include seizure, loss of consciousness, difficulty breathing, and death.
W&L Can Help Individuals Harmed After Ingesting Teething Products
Weitz & Luxenberg’s Drug & Medical Device Litigation Unit Practice Group Co-Chair Ellen Relkin says the firm is interested in hearing from anyone whose child or infant suffered death or injury, including loss of or reduced consciousness, seizures, or difficulty breathing, requiring hospitalization, after ingesting the following homeopathic teething products:
- Hyland’s Baby Natural Relief Teething Tablets
- Hyland’s Baby Natural Relief Nighttime Teething Tablets
- Hyland’s Baby Teething Gel
- CVS Homeopathic Infants’ Teething Tablets
Families may be entitled to compensation for medical expenses and other costs. An experienced attorney can help explore all legal options.
Ms. Relkin has played in lead roles in several major dangerous drug litigations, including serving on the court-appointed Executive Committee of the MDL involving the Ortho Evra birth control patch. She was also part of the trial team that secured a $13.5 million verdict in a case involving the medication Vioxx and the risk for heart attack.
Weitz & Luxenberg is ready to assist you, beginning with a free consultation. Contact us at (866) 268-2926 or by using the online form on this page to discuss your legal options.