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Reports of seizures in infants and toddlers have prompted the U.S. Food and Drug Administration (FDA) to issue a warning about homeopathic teething tablets and gels sold by CVS, Hyland’s and possibly other retailers. The agency is recommending that consumers immediately discontinue use of these products and throw them away.
In response to the warning, CVS on Friday, September 30, began pulling all brands of homeopathic teething products sold in its retail stores and through its website. The company also placed a “do not sell” block on store registers to prevent the items from being sold. The products affected include:
- Baby Orajel Naturals Gel for Teething Pain, .33 oz
- Baby Orajel Naturals Gel for Teething Pain Nighttime Formula, .33 oz
- Baby Orajel Naturals Tablets for Teething Pain, 125 Count
- CVS Homeopathic Infant’s Teething Tablet, 135 Count
- CVS Homeopathic Infants’ Teething Liquid, .85 oz
- Hyland’s Baby Nighttime Teething Tablets, 135 Count
- Hyland’s Baby Teething Gel, .5 oz
- Hyland’s Baby Teething Tablets, 13 Count
- Hyland’s Baby Teething Tablets, 135 Count
- Hyland’s Teething Gel, .33 oz
Hyland’s issued a statement that read in part, “We are fully cooperating with FDA’s inquiry and we’re providing them with all the data we have. We also hope to learn from FDA what facts, if any, the Agency has based its action on.”
Homeopathic teething tablets and gels did not undergo a pre-market evaluation process and have not been approved by the FDA for safety or efficacy. The agency states that is not aware of any proven health benefit of the products.
“Teething can be managed without prescription or over-the-counter remedies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We recommend parents and caregivers not give homeopathic teething tablets and gels to children and seek advice from their health care professional for safe alternatives.”
Any consumers who have used the products on their teething children should “seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething tablets or gels,” according to the FDA. The agency is analyzing adverse events, including seizures, that have been reported and testing product samples.
Proving a personal injury or wrongful death case for an infant or child requires medical and scientific expertise in an array of disciplines ranging from neonatology and pediatric gastroenterology to epidemiology and genetics. For this reason, our law firm has spent years developing a strong background in these areas and cultivating relationships with world-class experts. To contact our legal team about a free case evaluation, click here.