The Therapeutic Goods Administration (TGA) has issued a safety advisory regarding imported unregistered melatonin products.
While doctors may choose to prescribe melatonin to their patients ‘off-label’ the TGA is warning of serious safety concerns after lab testing indicated significant discrepancies in the levels of melatonin content in products compared to the labelled amounts.
The results of testing of 11 melatonin products, which can be purchased online from other countries, found three had less melatonin than labelled, including one which had none. Eight of the products tested had more, with one containing more than 400% of the labelled content.
The TGA has warned this variability raises serious safety concerns for consumers, including the risk of hospitalisation and accidental overdose, especially in children.
While the administration does not regulate clinical practice for off-label use, it reminded health professionals that while off-label use was allowed it should be assessed on a case-by-case basis.
“It is a clinical decision made at the discretion of the treating clinician who is responsible for obtaining informed consent from their patient and ensuring that the medicine is the appropriate treatment option and carries a positive benefit–risk profile.”
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RACGP Vice President and WA Chair Ramya Raman said GPs should be addressing sleep concerns before considering whether to suggest melatonin use.
She suggested doctors ask parents to consider seep hygiene in children.
“Ensure they are not taking devices to bed and if they are really little, making sure they are not using devices near their bedroom and having regular bedtimes. It sounds simple, but it makes a tremendous difference,” Dr Raman said.
She said there was a concern that children could overdose on melatonin if they took unregistered products.
“Overdosing on melatonin would result in things like nausea, vomiting, and gut disturbances but also sleepiness and irritability.”
She also stressed that in most cases melatonin use should not be a long-term solution.
“I’ve got patients who use melatonin, and it is for six to 12 weeks with appropriate review, and monitoring,” she said.
The TGA’s safety advisory noted that health professionals play a key role in identifying and managing the risks associated with unregistered melatonin products and should advise patients accordingly.
Health professionals are encouraged to report adverse events involving medicines, including unapproved medicines, to assist the TGA in identifying previously unknown side effects and other safety issues.
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