VITAMIN gummies for kids have been urgently recalled over fears they contain a prescription-only sleep drug.
The Medicines and Healthcare products Regulatory Agency (MHRA) told parents who’d bought Nutrition Ignition Kids Magnesium Glycinate Gummies to help their tots sleep to “stop all use” immediately.
It said testing had identified undeclared melatonin – a prescription only medicine used to treat sleep disorders – in certain batches.
Ingestion of melatonin won’t cause “lasting harm” in kids, the MHRA said.
But it can leave children feeling drowsy, dizzy or nauseous if they take too much.
The health watchdog is also working with online retailers to remove the gummies from sale.
Magnesium glycinate is a dietary supplement that can help with anxiety and improve sleep.
The Nutrition Ignition Kids Magnesium Glycinate Gummies are marketed to children above the age of four to support “calm, focus, and digestion”.
But tests on two batches of vitamins showed between 1.5 and 1.7mg of melatonin in each individual gummy.
Melatonin, the hormone that helps regulate the sleep-wake cycle, is naturally produced by the body.
However, a synthetic version can be prescribed to adults and children over the age of six in UK if they suffer from sleep disorders such as insomnia.
If prescribed, the recommended starting dose is 1mg for children.
According to the MHRA, melatonin is not listed anywhere on the packaging of Nutrition Ignition Kids Magnesium Glycinate Gummies.
The packaging advises a dose of one to two gummies per day, depending on the child’s age.
“Lasting harm is not expected when ingesting melatonin at high levels, and the body typically clears this within 12 hours,” the MHRA said.
But taking too much melatonin can cause headaches, drowsiness, dizziness and nausea, the health watchdog added.
suppliedMagnesium glycinate is a dietary supplement that can help with anxiety and improve sleep[/caption]Dr Alison Cave, chief safety officer at MHRA, said: “We advise any parent or caregiver to stop use of this product and safely dispose of it.
“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.
“No serious side effects were observed in studies in children.
“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.”
Nutrition Ignition Kids Magnesium Glycinate Gummies are sold online as a food supplement, but the MHRA has now removed the product from sale and is working with online retailers to remove all listings.
Parents or care givers who have this product at home were advised to store it securely in a tamper-proof container out of reach of children until they can take it to a pharmacy for disposal.
What is melatonin and who can't take it?
Melatonin is a hormone that occurs naturally in your body.
At night, your levels of melatonin rise, before returning to normal during the day.
This helps to control how and when you sleep.
You can take a synthetic version of melatonin for short periods if you have sleep problems such as insomnia.
This adds to your body’s natural supply of melatonin, so you fall asleep more quickly and you’re less likely to wake up during the night. It may also help with symptoms of jetlag.
Melatonin is mainly used to treat short-term sleep problems in people aged 55 or over.
It can also sometimes be prescribed by specialists to help with longer-term sleep problems in some children and adults.
Melatonin is available on prescription only.
It’s not suitable for some people. To make sure it’s safe for you, tell your doctor or pharmacist before taking it if you:
Have ever had an allergic reaction to melatonin or any other medicine Have liver or kidney problems Have rheumatoid arthritis, multiple sclerosis or lupus, or any other autoimmune conditionSide effects of melatonin
Melatonin doesn’t have many common side effects but it can cause the following:
Feeling sleepy or tired in the daytime Headache Stomach ache Feeling sick (nausea) Feeling dizzy Feeling irritable or restless Dry mouth Dry or itchy skin Pains in your arms or legs Strange dreams or night sweatsSource: NHS
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