Hyland’s Teething Tablets and Gels, homeopathic medications marketed for use in children, have been linked to severe side effects, including non-epileptic seizure disorders. The teething tablets have already been linked to the deaths of 10 children, according to the US Food & Drug Administration, along with 400 adverse events.
Hyland Teething Tablets “May Pose Risk” To Children
The FDA has formally warned parents and caregivers, instructing them to discontinue the use of homeopathic teething remedies immediately. In a public warning letter released on September 30, 2016, the US Food & Drug Administration cautioned families that “homeopathic teething tablets and gels may pose a risk to infants and children.”
This is not the first time federal authorities have warned caregivers about homeopathic teething products. In fact, Hyland came under federal investigation in 2010, after the FDA received multiple adverse event reports linked to the company’s teething tablets and gels.
Belladonna: Deadly Nightshade In Infant Teething Products
The homeopathic products contain trace amounts of belladonna, an extremely-toxic plant often known as “deadly nightshade.” The substance is “widely regarded” as dangerous, WebMD reports, because it can inhibit natural functions of the body’s nervous system. The National Institutes of Health, among other medical authorities, consider belladona “likely unsafe when taken by mouth.”
Very low doses of belladonna, however, are commonly used in homeopathic products, including teething tablets and gels labeled for use in infants. Homeopathic products are not evaluated or approved for safety purposes by the FDA. The agency is unaware of any “proven health benefit” created by the teething products.
Symptoms “Consistent” With Belladona Poisoning
Federal researchers have found evidence that links the wave of severe adverse events in children to the belladonna contained in Hyland’s Teething Tablets and Gels.
In 2010, government-run lab tests discovered “inconsistent amounts of belladona” in tablets manufactured by Hyland. Further inspections found “substandard” manufacturing controls at Hyland’s facility. The agency’s worries were increased because Hyland’s products did not feature a child-proof cap, and several children had consumed more tablets than recommended. Further, serious adverse events analyzed by the FDA were “consistent with belladona toxicity,” including symptoms like:
- difficulty breathing
- excessive sleepiness
- muscle weakness
- skin flushing
- difficulty urination
According to the FDA, parents should stop giving these products to their children immediately. The federal health agency recommends throwing out any unused homeopathic teething tablets or gels.
Hyland Discontinues Teething Tablet Distribution
Only 12 days after the FDA’s most recent warning, Hyland announced that it would be discontinuing distribution of the homeopathic teething tablets in the United States. But Hyland stands behind its product, writing in a press release dated October 11, 2016: “we are confident that any available Hyland’s teething products, including those you have, are safe for use.” The company says its decision was due, not to safety risks, but the “confusion among parents” caused by the FDA’s warnings.
The FDA, however, may not be convinced. The agency has launched further investigations of Hyland’s Teething Tablets, including laboratory testing of product samples. Many legal observers believe that teething tablet and gel lawsuits could be on the horizon, as parents become aware of the link between homeopathic teething products and severe side effects.
CVS, Walgreens Pull Hyland Teething Tablets From Shelves
CVS, the country’s largest pharmacy chain, has voluntarily pulled homeopathic teething products from the shelves of its 9,600 locations.
Included in the withdrawal are Hyland’s Baby Nighttime Teething Tablets, Baby Teething Tablets and Teething Gels, along with homeopathic teething products manufactured by Orajel. In an announcement issued immediately after the FDA’s most recent warning, CVS informed the public that “a ‘do not sell’ block has been placed in the Company’s store register system to prevent further sale of any” homeopathic teething products.
Walgreens has followed suit, withdrawing every homeopathic teething product implicated in the FDA warning.
Hyland Teething Tablet Lawsuits
Our attorneys are now investigating the potential for lawsuits involving injuries and seizure disorders linked to Hyland Teething Tablets and Gels. If your child experienced severe side effects after receiving a homeopathic teething product, your family may be entitled to significant financial compensation.
Contact our experienced attorneys today to learn more about your legal options. Receive a case evaluation – at absolutely no charge – now.