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



'No Gladstone tax': Sexy new business caters for all

NEW VENTURE: Suzi Gould, Caroline Connor, Amanda Richards, Janet Miller and Nathan Gould at Gladstones new lingerie store.

THIS Gladstone couple run three businesses

Mystery boat involved in fatal Curtis Island accident found

Police divers search a dam west of Lawrence in connection to the disappearance of Sharon Edwards.

The boat sunk off the northern end of Curtis Island

HEATWAVE: Severe warning for Gladstone, sweltering temps rise

WEATHER WARNING: Temperatures continue to soar as the heatwave covers Queensland.

GLADSTONE will feel 'severe' heat today and tomorrow

Local Partners

Peppa Pig a popular hit

Lovable children's character Peppa Pig visited Gladstone on Tuesday.


New Year New Yard

Win $1000 Bunnings Voucher
Learn More

Noll meltdown won't affect Gympie Oz Day concert

Shannon Noll

Photo Contributed

Shannon Noll is still expected to perform in Gympie next Thursday

11 huge events coming to Gladstone in the next 6 months

Events coming up in Gladstone in 2017.

Your guide to exciting events coming to the Gladstone region

Summer SUNfest kicks off

SunFest Lazer shoot-out in the Tondoon Botanic Gardens January 11, 2016. Photo Mike Richards / The Observer

Tickets for SUNfest are selling fast, so get in quickly.

They're floating their way to Agnes Water

MUSIC: The Floating Bridges will be performing at the Agnes Blues, Roots and Rock festival next month.

"Sharing good vibrations”: Band set to impress

Why Emma Watson turned down Cinderella

Emma Watson in a scene from the movie Beauty and the Beast.

HARRY Potter star has standards when it comes to Disney princesses.

Wonder Woman a ‘disjointed disaster’, says DC insider

Gal Gadot in a scene from the movie Wonder Woman.

INSIDER says the much-hyped blockbuster will disappoint.

Kid nails Swift impersonation

Seven-year-old Xia Vigor nails Taylor Swift impersonation on the Philippine talent show Your Face Sounds Familiar Kids.

TAYLOR Swift has a seven-year-old doppelganger.

Global sensations holding music workshops

Bobby Alu will be giving music lessons at Agnes Blues, Roots and Rock Festival as well as perfoming.

'Small lessons': global musicians holding intimate workshops

WATCH: Man can balance toilet seat on head, coming to Gladstone

Stephen Robertson is coming to Gladstone to perform his balancing act at Fast Track Talent in February.

VIDEO: Man can balance brooms on his face

Sunday auction for historical home

Former Catholic school sure to attract spirited bidding

Looking back, looking ahead in Noosa

NEVER-ENDING GLORY: Looking towards Laguna Bay and Hastings St from Noosa National Park.

Natural appeal of Noosa continues to attract buyers

Thousands of jobs part of $1b retirement village project

THIS YEAR: An artist impression of the new Aveo retirement village in Springfield.

Aveo Springfield unveiled this month, homes ready by July

KNIFE-EDGE: The housing tightrope we now face

Even the smallest interest rate rise will be hard for some to handle.

One if five home owners at risk, according to new analysis

'Difficult times': Rental prices tipped to increase in 2017

GREAT BUYS: There are some great rentals and houses to buy in South Gladstone. Head to gladstoneobserver.com.au for the top 10 homes under $100 to rent right now in the Gladstone region.

Investors may soon see a "profitable return” on properties.

Ready to SELL your property?

Post Your Ad Here!