The US Food and Drug Administration is warning parents to stop using Hyland’s homeopathic teething treatments immediately while they investigate the possibility that they may be connected to the the deaths of ten babies.
More than 400 babies have reportedly fallen ill and suffered seizures as a result of using the tablets and gels, which were widely stocked by American pharmacies.
CVS and Walgreens have removed eight different Hyland’s homeopathic teething products from their shelves. They can also be purchased online through sites such as Amazon, so any parents who may have ordered them is advised to dispose of them immediately.
And it’s not the first time the company has been in hot water. In 2010, Hyland’s were ordered to recall their teething tablets after the FDA discovered that the amount of belladonna, also known as deadly nightshade, contained in them was inconsistent.
What is belladonna?
Belladonna is included in teething products to ease the redness, inflammation and gum discomfort. In large amounts, the plant extract is poisonous but when homeopathically prepared, homeopaths say the active ingredients are diluted to the point that the risk of toxicity is extremely low.
According to the FDA statement on the matter, 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.
“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.”
The FDA is currently investigating and testing product samples. In a statement, the agency said “the relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review,” .
In an emailed statement, Hyland’s confirmed told CNN that it has stopped distributing in the US for the time being,
“Hyland’s has not been made aware of any data that supports the claims in the warning against our teething tablets and gels. Our understanding is that the Food and Drug Administration’s investigation of these products is still ongoing.
“This decision was made in light of the recent warning issued by the Food & Drug Administration against the use of homeopathic teething tablets and gels. This warning has created confusion among parents and limited access to the medicines,”
“We are confident that any available Hyland’s teething products, including those you already have, are safe for use,”
The FDA will continue to communicate with the public as more information is available.
The HSE recommends discussing all teething gel options for babies with your GP before using them.
