SIX IN HOSPITAL AFTER BOTOX INJECTIONS - UNAPPROVED PREPARATION, UNREGISTERED CLINIC OR HOME ADMINISTRATION ARE BEING EXAMINED BY AUTHORITIES IN DENMARK - UNDER THE MICROSCOPE OF THE ECDC AND EMA - Filenews 21/9
Six people in Denmark were hospitalized with severe botulism after injections of botulinum toxin, commonly known as Botox, made for aesthetic purposes or to treat excessive sweating.
The authorities are considering three critical possibilities from the beginning: the use of an unapproved preparation, the administration in an unregistered aesthetic clinic or the performance of the act at the patients' home by an unauthorized person.
However, the seriousness of the case was such that it was included in the official report of the European Center for Infection Control and the European Medicines Agency was notified.
At the moment, none of these possibilities have been confirmed. According to the initial announcement of the competent Danish Patient Safety Authority, none of the six patients wanted to disclose where and from whom they received the treatment. Authorities also cannot say for sure whether the incidents are linked.
The hospitalizations were recorded in Sejelan, the island where Copenhagen is located. It remains unknown whether the symptoms were caused by the preparation itself, by the wrong dosage or by the method of administration. The ECDC's weekly report confirms that the source of the exposure to the toxin is still being investigated.
Why was the European Medicines Agency also informed?
The severity of the cases, combined with the unknown origin of the product, led the European Centre for Disease Prevention and Control to inform the European Medicines Agency. Authorities are investigating whether additional cases may have occurred in other countries.
The ECDC assesses the risk to the general population of the EU as low, but points out that the risk may be higher for persons undergoing cosmetic or therapeutic procedures in informal or non-registered places.
The substance administered is described as botulinum toxin, more commonly known to the public as "Botox". Botox is a brand name for a specific product; There are other botulinum toxin preparations. The Danish authorities have not announced which product was used in the six patients.
Symptoms that should not be ignored
Botulinum after botulinum toxin injection is rare, but it can cause severe muscle weakness and breathing problems. The Danish Authority lists double vision or other visual disturbances, difficulty speaking or swallowing, severe muscle weakness, paralysis and difficulty breathing as risk indications.
Anyone who develops such symptoms after a recent injection should seek medical attention immediately and report that they have been given botulinum toxin. Difficulty breathing or swallowing is an emergency.
The doctor, the product and the place before the price
The case of Denmark comes to reinforce the warnings of Cypriot doctors last week who, during a press conference of the Pancyprian Medical Association, made recommendations including in their briefing earlier warnings of competent scientific societies.
As the doctors pointed out, the first step before such an act is for the citizen to turn to a registered doctor with an appropriately recognized specialty, training and experience in this intervention.
In the ECDC report there is no reference linking the Danish case with Cyprus. The six incidents show, however, how important it is to be able to clearly answer the questions "who", "where" and "with what" before the injection.
