In a news release late last month, the U.S. Food and Drug Administration (FDA) urged parents not to give their babies Hyland’s homeopathic teething tablets containing belladonna.
Parents have used homeopathic teething tablets since the early 1900s to provide temporary pain relief to babies who are growing their first teeth.
However, laboratory analysis by the FDA revealed that Hyland’s tablets contain inconsistent amounts of belladonna, with some containing far more of the substance than is indicated on the product label.
The FDA has received more than 400 reports of adverse events related to teething tablets with belladonna. Most of the adverse events were seizures, but there were also 10 reports of deaths.
Allowing your baby to use a product with belladonna is an unnecessary risk because it is difficult to predict how a baby’s body will respond to this substance, according to FDA spokeswoman Lyndsay Meyer.
The FDA news release advises parents to seek immediate medical attention if they have given their children Hyland’s teething tablets and their children experience any of the following side effects:
- Labored breathing
- Muscle weakness
- Flushed skin
- Difficulty passing urine
The FDA released its first warning about teething products with belladonna in 2010, noting inconsistent levels of belladonna in the tablets. The FDA released its second warning in September 2016, urging parents to stop using the product and throw away any tablets in their possession.
The manufacturer of Hyland’s teething tablets, Standard Homeopathic Co., discontinued the product on Oct. 7, 2016. The manufacturer claims that the product is safe, but it did not want to create confusion among parents in light of the FDA’s second belladonna warning.
You can submit adverse event reports online or download the reporting form and fax it to 1-800-FDA-0178.
Did your child suffer an injury or become sick after taking homeopathic teething tablets you thought were safe? O’Connor, Acciani & Levy’s product liability lawyers will fight to protect your family as we work to collect fair compensation for your medical bills, lost wages, and pain and suffering. Call today.