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October 13, 2016WHAT HE SAID…
October 18, 2016
Managers of some drug stores in the Bayou Region confirm that they have removed teething gels and tablets from their shelves in response to a warning from the U.S. Food and Drug Administration.
The products specifically mentioned are Hyland’s and CVS brands of teething tablets and gels. Hyland’s, headquartered in Los Angeles, has announced that due to the FDA warning, the company has voluntarily halted distribution of its products in the U.S.
“The FDA recommends that consumers stop using these products and dispose of any in their possession,” the warning states. “Consumers 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.”
The FDA says it is analyzing “adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets.”
Class action litigation begun in 2012 alleges that 10 deaths are related to the products. No wrong-doing on the part of manufacturers has been verified.
But some retail outlets, since the FDA warning, are taking no chances.
“We had them taken off the shelves,” said Jessica Oubre, manager of a CVS store in Houma. Stores are not issuing refunds to consumers who have already purchased the products. But purchasers are free to contact manufacturers if they wish.
An FDA advisory says that Hyland’s tablets contained varying amounts of belladonna, a potentially toxic ingredient, and that the agency has received reports of “serious adverse events in children taking this product that are consistent with belladonna toxicity. An ongoing FDA inspection at the manufacturer indicates substandard control of the manufacturing operation. FDA has also received reports of children who consumed more tablets than recommended, because the containers do not have child resistant caps.”
Homeopathic teething tablets and gels have not been evaluated or approved by the FDA for safety or efficacy. The agency is also not aware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children.
FDA officials maintain that teething can be managed without prescription or over-the-counter remedies.
“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.
Despite its decision to withdraw the products from the U.S., Hyland’s says it stands by all of its products.
“For generations, we at Hyland’s have been proud to offer safe, effective and natural health solutions to families … for over 90 years, parents have trusted Hyland’s teething medicines to ease the pain of teething in infants,” a statement from the company reads.
The decision to withdraw from the U.S. market, according to the statement, was made “in light of the recent warning issued by the Food & Drug Administration against the use of homeopathic teething tablets and gels.”
A company spokeswoman, Mary Borneman, said the recipes for its products have remained the same since at least 1949, with earliest references to the product itself in 1925.
“We are proud of our teething tablets product and the consumer response to it,” said Borneman, who found the FDA warning “disappointing.”
If parents who have the product in their homes are displeased with it, Borneman said, the company will do what it always has which is stand behind what it produces, and that requests for refunds will be made if products are returned to it because of discomfort with the warning.
Hyland’s teething products like this one are among those that are the subject of an FDA warning.
