Health officials have urgently recalled a brand of children’s gummies over fears it could be laced with a prescription-only sleeping drug.
UK medicines watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA) stuck an alert on Kids Magnesium Glycinate Gummies, manufactured by Surrey-based company Nutrition Ignition.
It is believed the raspberry-flavoured wellness supplement contains melatonin, which is not listed anywhere on the product’s packaging.
Melatonin is a hormone naturally produced by the body to help regulate the sleep-wake cycle and it can also be prescribed by doctors in the UK for treating sleep problems.
But medics have long sounded the alarm over the number of patients admitted to hospital with alleged melatonin overdoses. It has also been linked to at least two infant deaths.
The MHRA, which published the alert today, said testing of two batches found melatonin levels of between 1.5 and 1.7mg in individual gummies.
The recall impacts all batches of Nutrition Ignition Kids Magnesium Glycinate Gummies and parents should dispose of any remaining product.
Dr Alison Cave, MHRA Chief Safety Officer, said: ‘We advise any parent or caregiver to stop use of this product and safely dispose of it.
UK medicines watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA) stuck an alert on Kids Magnesium Glycinate Gummies, manufactured by Surrey-based company Nutrition Ignition
Melatonin gummies are available in China, the US and in some European countries without prescription despite doubts about their long-term safety
‘Side effects such as headache, hyperactivity, a feeling of dizziness and abdominal pain have been reported in children when melatonin is prescribed and used for its licensed indications.
‘Anyone who suspects that their child, or a child in their care, is having a side effect from this product is advised to stop taking it and speak to a healthcare professional and report it directly to the MHRA Yellow Card scheme.’
The scheme, set up in the 1960s, allows doctors, pharmacists and patients themselves to report adverse reactions believed to be caused by prescription and over-the-counter drugs, implants and alternative medicines.
This can lead to them being reviewed, having warnings added to the label or even being taken off the market.
A synthetic version of melatonin is authorised for use on prescription in the UK for adults and children over the age of six with sleep disorders such as insomnia.
Melatonin gummies are available in China, the US and in some European countries without prescription despite doubts about their long-term safety.
In the UK, however, a hidden market has developed for melatonin gummies, particularly among parents of neurodivergent children.
US data shows melatonin supplements have also been linked to a 500 percent increase in overdoses in kids over the past decade.
US data shows melatonin supplements have also been linked to a 500 percent increase in overdoses in kids over the past decade
Sleep experts have previously told the Daily Mail that demand for the supplement has ‘gotten out of hand’.
Melatonin has been linked to infant deaths too.
One 2019 study documented two cases—one nine-month-old and one 13-month-old—after blood toxicology tests showed high levels of melatonin in both cases.
However, there were other factors that may have played a role in both deaths.
The first baby was found co-sleeping with an older sibling, while the second was left in a hot room – both known risk factors for sudden infant death syndrome (SIDS).
Studies in rats and mice have only shown that melatonin may have toxic effects if given in incredibly high doses of more than 400mg.
