Teething products pulled from sale in NZ
This article was first published March 27, 2017.
American company Hyland’s stopped distributing its homeopathic teething tablets and gels in the United States in October after a Food and Drug Administration warning, but New Zealand parents may not know of the risk
A popular treatment for teething babies has been pulled from sale in New Zealand, after a Newsroom report about possible links to seizures and deaths.
American company Hyland’s stopped distributing its homeopathic teething tablets and gels in the United States in October 2016 after a Food and Drug Administration (FDA) warning telling parents to stop using the products.
The FDA has since asked Hyland's to recall the products, but the company, which says the products are safe, hasn't agreed.
Medsafe told Trade Me to remove the products from sale after Newsroom contacted the Ministry of Health. The auction website says it removed the listings immediately and will monitor the site to make sure no new listings emerge.
Medsafe group manager Chris James says the products can’t be sold in New Zealand because they make therapeutic claims (to relieve teething symptoms), yet they haven’t gone through the process for approval as medicines.
Another New Zealand website removed the product page after being contacted by Newsroom, while a representative from a third was horrified to be told of the potential risk, and said she would immediately remove the products and ask her supplier for a refund. She said because the product was homeopathic (meaning ingredients are present in very diluted form) she’d thought there’d be no danger.
Though Hyland’s maintains the products are safe, lab tests show some samples have higher doses of atropa belladonna, or “deadly nightshade”, than is stated on the label.
The FDA put out a warning in September saying consumers should stop using homeopathic teething tablets and gels sold by Hyland’s, CVS pharmacies and others, and throw away any products they had already purchased. The agency is investigating reports of seizures and other “adverse events” including deaths of babies, though the FDA hasn’t yet concluded whether it was the teething products that caused the deaths.
“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 labelled to relieve teething symptoms in children,” said the FDA’s warning. “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.”
In contrast to the FDA warning about sleepiness, the listing for Hyland’s teething gel on Trade Me reassured parents their babies may become sleepy after using the gel: “If your baby has been crying or upset, your baby may fall asleep after using this product because the pain has been relieved and your child can rest,” it said.
Last month STAT News, a medical news website owned by the same company as the Boston Globe, obtained FDA records under US freedom of information laws showing babies who were given Hyland’s teething products suffered twitching, seizures and, in some cases, turned blue and died. Between 2006 and 2016 the FDA collected more than 370 reports of problems in children who used the tablets or gel, including eight cases where babies died, STAT reported.
Hyland’s released a statement when it stopped selling the products saying it was confident the products were safe. But the company said the FDA warning had confused parents and divided retailers about whether to keep selling the products. “It is therefore with much sadness that we share with you that we have chosen to discontinue the distribution of our Hyland’s teething medicines in the United States ... putting you in a position of having to choose who to trust in the face of contradictory information is burdensome and undermines the FDA,” it said.
The company hasn’t recalled the products, despite being asked to by the FDA.
STAT’s reporting shows the FDA kept receiving reports of problems tied to the teething products, even after it pushed Hyland’s to reformulate the gel and powder in response to concerns in 2010. The FDA’s worries focused on a toxic ingredient called atropa belladonna, otherwise known as “deadly nightshade." While it wouldn’t pose any health risk in low doses, it was found at inconsistent levels in Hyland’s products. The ingredient can be neurotoxic at bigger doses and is rapidly absorbed by the skin and mouth, with infants being extra susceptible, warned the FDA.
In January, the FDA issued another warning to American parents, saying testing showed that levels of belladonna sometimes far exceeded the amounts stated on the label and revealing it had asked Hyland’s to order a full recall, but Hyland’s had not agreed.
Another company, Raritan Pharmaceuticals, has recalled three belladonna-containing homeopathic products, said the FDA statement. “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 in the statement.
In New Zealand, a bill that would give the Ministry of Health more power over natural health products is awaiting a final debate in Parliament. Medsafe’s Chris James says there is no timeframe in place for this to happen.
There have been concerns the Natural Health and Supplementary Products Bill will add to the cost of selling harmless nutritional supplements, though proponents say the bill is needed to ensure non-prescription products are safe and that they do what they say on the label.
In the meantime, any products claiming to have a therapeutic effect – for example relieving teething symptoms - are considered medicines under New Zealand law, meaning they need approval under the Medicines Act before being sold here. James says the Hyland’s tablets and gels did not have that approval and did not meet the definition of a dietary supplement, so they could not be sold as a dietary supplement either. The medicines assessment is to make sure products meet international requirements for quality, safety and efficacy, James said.
“Any other sellers identified in New Zealand will also be contacted by Medsafe to halt their sale,” said James in an email. “No previous complaints have been received by Medsafe about these products and there have been no reports to the Centre for Adverse Reactions Monitoring of adverse reactions about these teething products.”
If parents do see problems: “People are encouraged to report any adverse effects from products, including alternative products, to Centre for Adverse Reactions Monitoring. Consumers should be aware of the risks if they are considering using unregulated products because their quality, efficacy and safety are unknown.”
In Australia, where the products have been for sale in pharmacies, the Therapeutic Goods Administration tested two batches of Hyland’s tablets and one batch of teething gel after hearing of the FDA warning last year and found no unsafe levels of belladonna.
But the regulator told the Melbourne Age last month it was considering whether to test more samples after the revelations in the latest FDA warning. Consumers were advised to be cautious about using the treatments and to get medical advice before giving teething tablets or gels to babies and children, said the Australian regulator.
CORRECTION: A previous version of this story contained a generic photo of a child with a teething product that is not the product reported on in this story. It has since been replaced. Newsroom apologises for the error.