Teething tablet fears prompt "urgent investigation" by TGA


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

Nannas try to 'arrest' MPs across the country

The Knitting Nannas at Kevin Hogan's office in Molesworth St and, below left, Knitting Nanna Dororthy Moller with an 'arrest warrant for Kevin Hogan.

Group storms office in brazen stunt

Kalti on the trail of grand master's title

TOP TRACKER: Tracey Knox and her champion tracking dog Kalti celebrate their latest title, a Master of Track and Search.

Tracey Knox and her dog Kalti are searching for new titles.

Shark attacks: What's behind the steep rise?

Shark attacks on people have significantly increased i

Local Partners

Green light for sports centre to re-open

NEW operators hoping existing users will return to sports centre and get 'business back to normal'.

Tea party with the 'Queen'

TRADITION: 1955 Jacaranda Queen Stella Wilson sits with reigning 2015 Jacaranda Queen Charlotte White at last year's Jacaranda Afternoon Tea.

Meet the royal patyu in style

Making steps for 'Blacky' in Walk 4 Brain Cancer

Grafton locals are doing a Walk 4 Brain Cancer in Sydney for Robert Black.

Team Blacky aims to better $5000 to battle brain cancer.

Sound of Music star to compere An Afternoon at the Proms

This photo provided by Twentieth Century Fox Home Entertainment shows, from left, Chairmian Carr, as Liesl, Nicholas Hammond, as Friedrich, Heather Menzies, as Louisa, Duane Chase, as Kurt, Angela Cartwright, as Brigitta, Debbie Turner, as Marta, Kym Karath, as Gretl, and Christopher Plummer, as Captain Von Trapp, in a scene from the film, \"The Sound of Music.\" The 1965 Oscar-winning film adaptation of the Rodgers & Hammerstein musical \"The Sound of Music\" is celebrating its 50th birthday in 2015. To honor the milestone, 20th Century Fox is releasing a five-disc Blu-ray/DVD/Digital HD collector's edition, the soundtrack is being re-released, the film will be screened at the TCM Classic Film Festival in Hollywood later this month and to over 500 movie theaters in April. (AP Photo/Twentieth Century Fox Home Entertainment)

Saraton's rich history of stage and screen honoured in musical tribu

REVIEW: Season 7 premiere of The Walking Dead disgusted me

I'm disgusted by The Walking Dead premiere.

SPOILERS: The Walking Dead premiere disgusted me.

Flick teases intense and entertaining Survivor grand final

Felicity 'Flick' Eggington in a scene from the TV series Australian Survivor.

GOLD Coaster's elimination leaves Lee, El and Kristie in final three

Priscilla concerned people will forget about Elvis

Priscilla Presley source Bang

She says she feels responsible to keep his legacy going

Taylor Swift files lawsuit over alleged groping

Taylor Swift source Bang

Swift has commenced legal action against a DJ over the incident

Kanye West threatens to boycott Grammys

West says he won't go to the Grammys if Frank Ocean's not nominated

Why this actress wasn't embarrassed by nude photo leak

Leslie Jones source Bang

'If you wanna see Leslie Jones naked, just ask,' she said

Hinterland horse stud passed in for $8.25 million

UNREAL: This Maleny estate is incredible.

12-bedroom hinterland horse stud still available

Hit songwriter's Noosa mansion on market

SPECIAL PLACE: The Cintamani estate is going to tender, marketed by Tom Offermann Real Estate.

Is this Queensland's best property?

Kiwi siblings snap up Dotcom mansion for $32.5m

The new toy company owners of the Coatesville mansion want replace any controversy with positivity and fun. Photo / Barfoot and Thompson

The trio paid $32.5 million for the property in June

New $200 million development will create 580 jobs

Cassie And Josh with baby Alfie and daughter Andee. They have bought at new Lennox Head development Epiq.

Majority of new positions will be given to Northern Rivers locals

Cherrabah's mega resort plans axed

PLANS for a massive development at Cherrabah have been scrapped.

Dusit Thani finance crisis 'just a small hiccup'

ON TRACK: Springfield Land Chairman, Maha Sinnathamby, Ipswich Mayor Paul Pisasale, Developer Richard Turner and Springfield Land Deputy Chairman, Bob Sharpless, at the recent resort sod turning ceremony.

Property developer says project remains firmly on track