The MHRA has issued new advice for parents and caregivers to stop all use of a specific brand of kids’ magnesium gummies due to the presence of an undeclared prescription-only medicine.
Those who have purchased Nutrition Ignition Kids Magnesium Glycinate Gummies are being told by the Medicines and Healthcare products Regulatory Agency (MHRA) to stop giving them to children and safely dispose of any remaining product. It is recommended that advice be sought from a healthcare professional if a child has any side effects that are of concern. This is due to the presence of undeclared melatonin, a prescription-only medicine.
Testing of two batches by the MHRA identified melatonin within the product. The gummies tested were found to contain between 1.5 and 1.7mg of melatonin in each individual gummy. Depending on the age of the child, the product packaging advised a dose of one or two gummies per day. Melatonin is not listed anywhere on the product’s packaging.
The product has only been sold online as a food supplement, however, given the presence of a medicine, the MHRA took action to remove the product from sale, working with online retailers to withdraw all listings. Anyone with this product at home is advised to store it securely in a tamper-proof container out of reach of children until they can take it to any pharmacy for disposal.
Melatonin is authorised for use in the UK as a prescription medicine for specific sleep disorders in both adults and children over the age of 6 years, where other sleep management approaches have been insufficient. If prescribed, the recommended starting dose of melatonin is 1mg for children. The dose in children can be increased to a maximum of 5mg per day before bed.
Dr Alison Cave, MHRA Chief Safety Officer, commented: “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.”
Melatonin is authorised for use in the UK as a prescription-only medicine for the short-term treatment of insomnia and jet lag in adults, insomnia in children and adolescents aged six-17 with attention deficit hyperactivity disorder (ADHD) or delayed sleep wake phase disorder (DSWPD), in cases where other sleep management measures have been insufficient. Some products are approved for single use as short-term sedation under medical supervision to facilitate electroencephalograms (EEG) (a recording of brain activity) in children and adolescents aged one to 18.
