Updated Thursday, April 11, 2024 – 10:10
The Spanish Agency for Medicines and Health Products (AEMPS) has prohibited the marketing and has ordered the withdrawal from the market of all copies of the capsules Melatonin 7which is sold as a food supplement when the dose of melatonin it contains gives it the status of a drug.
The agency dependent on Ministry of Health has learned from the Consumer, Environment and Doping Section of the General Commissioner of the Judicial Police of the marketing of these capsules by the Polish company 7 Nutrition as a supplement “despite not having been notified of their placing on the market to the competent authorities.” , failing to comply with the provisions of current regulations for this type of products,” highlights the Aemps in a note.
As indicated on its labeling, it contains melatonin at a dose of 5 mg per capsule“sufficient quantity to restore, correct or modify a physiological function” by exerting a pharmacological action, which gives it the status of medicine.
In Spain, there are medications authorized for marketing in Spain whose active ingredient is melatonin, with a dose of 2 mg, which is a lower amount than Melatonin 7.
Melatonin or N-acetyl-5-methoxytryptamine, explains Aemps, is a hormone produced by the pineal gland structurally related to serotonin that participates in a wide variety of cellular, neuroendocrine and neurophysiological processes.
This hormone is fundamentally associated with the control of circadian rhythms and adaptation to the light-dark cycle. In addition, it is associated with a hypnotic or sleep-stimulating effect.
With the consumption of melatonin, adverse effects may appear such as irritability, nervousness, restlessness, insomnia, strange dreams, migraine, lethargy, psychomotor hyperactivity, dizziness, hypertension, stomach pain, dyspepsia, mouth ulcers, dry mouth, hyperbilirubinemia, dermatitis, sweating. nighttime, itching, skin rashes, dry skin, pain in the extremities or symptoms of menopause, among others.
It may also cause drowsiness, so it “should be given with caution” if it may pose a safety hazard, for example when given to people who have to drive or use machines.
Equally, Its use is contraindicated with alcohol consumption and should not be administered to people who may be hypersensitive (allergic) to melatonin.
Due to all the aforementioned risks, as well as the fact that the aforementioned product “has not been subject to evaluation and authorization prior to its commercialization” by the agency, this is why the Aemps has decided to take the precautionary measure of prohibiting its marketing and request the withdrawal of all its copies from the market.
