Melatonin from some online suppliers has been found to have as much as four times the amount advertised, or even no melatonin at all, according to testing by the national drug regulator.
In a new safety note, The Therapeutic Goods Administration (TGA) said patients should stop using unregistered imported melatonin products immediately, after testing in its laboratories indicated “significant discrepancies” between the actual melatonin amount and what was on the label.
Almost a dozen different products examined by the TGA were found to have significantly more or less melatonin than the labelled amount.
One was higher than 400 per cent.
“This variability in melatonin content raises serious safety concerns for consumers, including the risk of hospitalisation and accidental overdose, especially in children,”
the TGA said.
These were the products found to have contained significantly more than the labelled amount, according to the TGA. (Supplied: TGA)
The TGA also declared it would crack down on the importation of unregulated melatonin products, warning the Australian Border Force would “seize and destroy” any products intercepted at the border.
It comes days after ABC News revealed Australian poisons hotlines had received a record number of about 1500 calls last year about children ingesting melatonin, a dramatic spike on previous years.
Online retailer iHerb also recently suspended melatonin sales to Australia, after reports of a jump in calls to the WA Poisons Information Centre about children taking melatonin.
Melatonin is a hormone that regulates the sleep-wake cycle and an increasing number of parents have turned to it to help their children sleep, either as a prescription or purchased online, sometimes in the form of flavoured gummies.
A prescription is technically required to use melatonin in Australia and is only approved for limited circumstances, like for autistic children.
However, many parents circumvent the process by opting to buy it from online overseas retailers as it is often significantly cheaper and can be bought without a script.
The TGA has warned those products may be fake, have incorrect or undisclosed ingredients, or might not meet Australia’s strict safety standards.
“Consumers who import these unregistered ‘melatonin’ products from online stores for personal use or use by an immediate family member risk serious health problems,” the TGA said.
Some products found to have 417 per cent of melatonin on label
Sleepose-3 Melatonin 3mg was among the products examined by the TGA in its laboratories, and was found to have as much as 417 per cent of the labelled melatonin content.
Natrol Melatonin 5mg gummies were found to have as much as 170 per cent of the melatonin advertised, while Live Natures Melatonin 10mg was found to have none at all.
These were the products found to have contained significantly less than the labelled amount, according to the TGA. (Supplied: TGA)
The TGA urged consumers to return any remaining supply of imported melatonin to a pharmacy for safe disposal.
“Parents are strongly encouraged to consult their child’s treating medical practitioner regarding the use of melatonin, especially for children with seizure disorders as it may increase seizure frequency,” the TGA said.
“Melatonin products taken without appropriate medical oversight can cause serious side effects including hospitalisation and accidental overdose, especially in children.”
Royal Australian College of General Practitioners vice president Ramya Raman said the results highlighted the importance of parents talking to a doctor before giving their children melatonin.
“It is quite concerning, the medication should match the label to be safe,” Dr Raman said.
“The main concern is safety and the effects of this on children … the risk would be overdosing or the risk of poisoning.”
“There’s also a risk that medications can have interactions with these sorts of online purchased medications and then cause an overdose… so there’s multiple things that need to be considered in this scenario.”
Some parents have told ABC News their doctor directed them to purchase melatonin online, noting it cost less money and was more convenient.
Dr Raman said while it was important not to worry families, they should be aware of the risks of using online products.
“Many people do buy melatonin online, but there needs to be caution around this,” she said.
“I would highly encourage patients to talk to their GP or their doctor.“
The TGA warned melatonin products purchased online were “extremely risky.”
“The TGA advises that children suffering from any medical condition, including sleep disorders or irregular sleep patterns, should see a doctor and not be given medicines purchased over the internet,” the regulator said.
ABC News has contacted the melatonin manufacturers identified by the TGA in its safety note.
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