Ten deaths of children who were given homeopathic teething tablets and 400 adverse events linked to the tablets have been reported to the U.S. Food and Drug Administration, the agency reported Wednesday. According to a KTLA news report, the FDA has warned caregivers to stop using these products, which are often used to soothe teething babies. They are also warning parents and caregivers to take their child to a doctor immediately if he or she experiences any problems.
The FDA is looking into the reported adverse events and the cases involving the deaths in an attempt to establish the relationship between the incidents and the teething tablets. Some of the symptoms reported in connection with these tablets, manufactured by Hyland’s, include fever, lethargy, vomiting, sleepiness, tremors, shortness of breath, irritability and agitation. The adverse events were reported to the FDA over the last six years. Hyland has discontinued distribution of its teething tablets and gels in the U.S. after the FDA alert.
Potentially Toxic Products
So far, there has been no recall on the products in question that include Hyland Baby Teething Tablets, Hyland’s Baby Teething Tablets Nighttime and Hyland’s Baby Teething Gel. CVS, which also sells its own brand of these products, has pulled all of them from its shelves as has Walgreen’s. The FDA issued a safety alert about the tablets in 2010 and Hyland’s issued a recall at that time. After lab testing, the FDA said it found inconsistent amounts of belladonna (a toxic plant) in the tablets.
The adverse events reported were consisted with belladonna toxicity.
Hyland’s said it has reformulated the product to reduce the amount of belladonna. The American Academy of Pediatrics has warned parents to stay away from these teething tablets or gels. Instead, the recommendation is to massage the child’s gums with a clean finger when the baby is in pain, use a solid teething ring or wet washcloth that has been chilled in the freezer. Also recommended for teething relief are frozen bananas, berries or bagels.
Why Were These Products Not Recalled?
It’s truly puzzling and disturbing as to why these seemingly toxic products have not been recalled after 10 deaths and hundreds of adverse events. We sincerely hope the FDA will expedite its investigation of these potentially dangerous products and initiate a recall so these tragic incidents can be prevented. If your child has suffered adverse side effects as a result of using teething tablets or gels, contact an experienced product defect lawyer to obtain more information about pursuing your legal rights.