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FDA Issues Additional Warning for Baby Teething Tablets

Steve Wagner


The American Academy of Pediatrics has been warning parents to stay away from teething tablets that contain belladonna and gels with benzocaine, citing the U.S. Food and Drug Administration ongoing warnings of the potential side effects. Now, in January of 2017, the FDA has issued another ‘loud’ warning for Hyland’s homeopathic teething products since the company has refused to recall.

Hyland’s has stood alongside this criticism since 2016 when the deaths of ten children who used homeopathic teething tablets and 400 adverse events associated with the tablets were reported to the FDA.

“Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children,” the FDA said.


Initial laboratory analysis conducted by the FDA found inconsistent amounts of belladonna, an extract of the deadly nightshade plant. It has hallucinogenic qualities and is toxic in large amounts.

“The body’s response to belladonna in children under 2 years of age is unpredictable and puts them at unnecessary risk,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “We recommend that parents and caregivers not give these homeopathic teething tablets to children and seek advice from their health care professional for safe alternatives.”

Belladonna alkaloids have anticholinergic effects. Soon after using the teething products, children may experience:

  • fast heart rate
  • increased body temperature
  • dry skin and dry mouth
  • disorientation
  • hallucinations
  • dilated pupils
  • seizures
  • difficulty breathing
  • lethargy
  • excessive sleepiness especially in infants
  • muscle weakness
  • skin flushing
  • constipation
  • difficulty urinating
  • agitation


Hyland’s withdrew teething products in October 2016, after the last FDA warning, but the company has yet to inform customers to rid their medicine cabinets of the product, stating they are confident that any available Hyland’s teething products are safe for use. Standard Homeopathic Co. in Los Angeles was the maker of the product up until October 7, 2016.

Many studies have shown that homeopathic products, like the tablets, do not benefit health in the ways they are marketed. The FDA does not approve such products.

Since 2010, the FDA has been urging parents and caregivers to stop using these products immediately and dispose of any in their possession and recommends that consumers contact their health care professional if their child experiences symptoms after taking Hyland’s Teething Tablets.

Defective drug cases are complex and can place consumers in a vulnerable place. Our experienced attorneys at Wagner Reese can help restore the balance of power, providing you the legal support and advice you need so that you can focus on the health and healing of your child.

Whether your child’s drug-related injuries were caused by defectively designed or manufactured drugs, by hidden side effects, or by inadequate warnings we offer a free, no-obligation consultation. Contact us now at (888) 204-8440 to schedule an appointment in our Indianapolis or Carmel offices, or use our convenient, confidential contact form.


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