News

Teething tablet fears prompt "urgent investigation" by TGA

EXCLUSIVE

PARENTS are being warned not to use homeopathic teething gels and tablets after they were linked to 10 deaths in the United States, as the Australian regulator investigates the products.

The Therapeutic Goods Administration has confirmed it has begun "urgent testing" of the range, aimed at calming distressed infants.

A TGA spokesperson said the drug regulator was urging parents "not to use the product while investigations are being conducted".

Manufacturer Hyland's has pulled the tablets and gels from shelves in US after the Food and Drug Administration warned the death of 10 children may be linked to the products.

The FDA - the American equivalent of the TGA - told parents to seek urgent medical help if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation after using the products.

The link between the homeopathic teething products and the deaths remains under review by the FDA.
 

The homeopathic teething tablets remain on sale in Australia, despite the company removing them from sale in the US.
The homeopathic teething tablets remain on sale in Australia, despite the company removing them from sale in the US.

In Australia, just as in the US, these products have avoided the kind of scrutiny applied to other medicines because they are a homeopathic remedy.

The FDA did not require the company to issue a recall on the products, although Hyland's voluntarily removed the items from sale.

The products remain for sale in pharmacies across Australia.

In 2010, the FDA received reports of illness in children who used the products was consistent with belladonna toxicity. At the time it also found the teething tablets had "inconsistent" amounts of belladonna.

Belladonna, also known as "deadly nightshade" is the active ingredient in the Hyland's products.

In a letter to its customers, Hyland's wrote that it would stop selling its teething gels and tablets in the US after the FDA's warning against their use.

The products are now subject to an "urgent investigation" by Australia's drug regulator.
The products are now subject to an "urgent investigation" by Australia's drug regulator.

The company maintains its products are safe to use, but added that parents with concerns should consult their doctor, and read the labels carefully.

In a statement, Hyland's wrote it "has not been made aware of any of the data" in relation to issues caused by its products.

"The fact is that we have not been made aware of any medical or statistical evidence to support a causal link between homeopathic teething tablets and adverse outcomes at this point," it wrote.

Hyland's has been sought for comment.

Topics:  baby drugs editors picks homeopathic parenting teething therapeutic goods association


Stay Connected

Update your news preferences and get the latest news delivered to your inbox.

Passenger dead, driver hurt as car hits power pole

The scene of the crash. Picture from Channel 7

Woman dies in crash south of Brisbane

Five men charged over alleged torturing at mechanic shop

Alexander Francis Pasquill, 24, coming out of the Southport Watchhouse.

The victim claimed he was taken from his home by up to 16 people

Councillor's $180k stealing charge hits court

Logan City Councillor charged with $180,000 theft

Local Partners

Car stolen from business

Police would like to talk to them in relation to a crime in Logan.

Puppetry of the Penis secrets revealed ahead of show

The famed Puppetry of the Penis is coming to the Sunshine Coast for shows in Noosa and Caloundra.

WARNING: This interview contains adult themes and traces of nuts

Noll meltdown won't affect Gympie Oz Day concert

Shannon Noll

Photo Contributed

Shannon Noll is still expected to perform in Gympie next Thursday

The surprising problem police face at Woodford Folk Festival

STREET SCENE: Woodford Folk Festival 2016.

The biggest issue for police at Woodfordia is not what you'd expect

Kristen Stewart to host SNL

Kristen Stewart will host a pre-Super Bowl episode of SNL next month

Louis Tomlinson celebrated his son's first birthday

Louis Tomlinson and Briana Jungwirth celebrate son's first birthday

Kylie Minogue will take husband's name

Kylie Minogue will take her fiancé Joshua Sasse's surname

Nicole reveals her biggest parenting challenges

Actress Nicole Kidman.

Nicole Kidman says her kids are ‘deeply attuned' to her moods.

Suicide Squad director reveals his regrets about the film

Margot Robbie in a scene from the movie Suicide Squad.

DIRECTOR of superhero flick on what he’d change about ‘flawed’ film.

Meet the new Marco on MasterChef Australia: Yotam Ottolenghi

Israeli-born, London-based chef Yotam Ottolenghi will be a guest chef for a week on the 2017 season of MasterChef Australia.

AFTER Marco’s defection to Seven, MasterChef signs a true food hero.

Stockland's $150m pitch: Build it and they will come

Gladstone Marina. The Gladstone Regional Council offers a range of exciting job opportunities. Photo Contributed: Murray Ware.

Here's why we need to see Stockland upgrade start soon.

By the water's edge

Secure your seachange

HOT PROPERTY: Money to spend on land, buildings

File picture.

Sale, leasing of industrial real estate picks up in Mackay

Collapsed Coast company could owe up to $5 million

Staff, ATO, landlords among those out of pocket.

Ipswich block of dirt sells for $582 a square metre

JUST SOLD: A property on the Brookwater golf course sold for a record-breaking $612,000.

Property smashed 2007 record by close to $100,000

Ready to SELL your property?

Post Your Ad Here!