The U.S. Food and Drug Administration FDA announced last Friday that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.
Teething in babies can be irritable for babies and it is difficult to keep them happy. This is challenging for parents who want to alleviate their suffering. There are many teething remedies out there to help babies deal with the pain of cutting teeth. These products can range from chew toys to homeopathic teething medications, such as teething tablets.
“The body’s response to belladonna in children under two years of age is unpredictable and puts them at unnecessary risk,” said Janet Woodcock, M.D., 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.”
The FDA originally issued a safety alert in 2010 that recommended against Hyland’s Teething Tablets based on laboratory results showing that they contained inconsistent amounts of belladonna. Since then, the agency has received more than 400 reports of adverse events linked to teething products that contain belladonna.
FDA recommends that consumers contact their health care professional if their child experiences symptoms after taking Hyland’s belladonna Teething Tablets. Symptoms include a depressed level of consciousness, seizure, difficulty or slowed breathing, lethargy, sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation.
Belladonna, which comes from the deadly nightshade plant, can be poisonous. The FDA found that Hyland’s homeopathic teething products in some cases had belladonna levels far exceeding the amount claimed on the label and asked the Standard Homeopathic Company in Los Angeles recall their product.
Standard Homeopathic Co., the Los Angeles-based maker of Hyland’s, discontinued its product October 7 itself. “We discontinued it because we are committed to our moms and our dads who choose to trust us to put medicines in their young infants’ mouths, and we didn’t want to put them in a place between the FDA warning and us saying the product was safe and having to decide who to trust,” said Mary C. Borneman, a spokeswoman for Hyland’s.
The FDA announcement Friday confirms its original laboratory assessment of inconsistent amounts of belladonna. “They showed some limited data on samples they tested that indicated inconsistent amounts of belladonna alkaloid at the nanogram level,” Borneman said. However, the results “remained within the documented margin of safety.”
“The implication in the FDA release is that consumers who still have the product shouldn’t use it because it might be unsafe” Borneman said.
The American Academy of Pediatrics recommends instead of using teething gels or tablets gently rubbing or massaging the child’s gums with your finger and giving the child a cool (not cold) teething ring or a clean, wet, cool washcloth to chew on.
Author: Sumana Rao | Posted on: January 30, 2017