Since 2016, the Laboratoire national de santé (LNS) has been conducting systematic quality studies of ”Viagra” type drugs seized by Customs. In recent years, the pharmacological quality has increased. However, in 2021, about one third of the seized drugs still did not comply with European legislation. Despite this improvement, the use of products purchased over the internet without a medical prescription from non-certified suppliers continues to pose a serious health risk to consumers.
The LNS’ analytical toxicology – pharmaceutical chemistry service in collaboration with Customs and the Health Directorate undertook a study between 2016 and 2021 on the quality of medicines seized by Luxembourg Customs.
Indeed, every year, many thousand drugs are illegally imported into the Grand Duchy of Luxembourg as a result of purchases made by individuals on internet sites. The Health Directorate submitted these products to the LNS in order to verify their chemical quality, as these products often do not have marketing authorisation in Europe or may be falsified products whose quality has never been controlled.
The study leaders, Dr Serge Schneider from the LNS and Marc Schmit, the pharmacist inspector from the Health Directorate, explain: “Medications authorised in Luxembourg are subject to strict quality criteria defined by the European Medicines Agency and are subject to quality controls. Non-compliant or falsified drugs can harm the health of consumers. They can lead to antibiotic resistance, infections, unexpected side effects and even increased mortality or morbidity. A recent study reported more than 7000 cases, including at least 3600 deaths between 2006 and 2017 in developed and developing countries.”
Over the last five years, 5570 products have been seized by customs, 55% of which were medicines indicated for erectile dysfunction of the “Viagra” type containing sildenafil, tadalafil or vardenafil as the active ingredient. The LNS team looked at drugs containing sildenafil, 991 products in total. The amount of sildenafil and the presence of undeclared contaminants were investigated.
The results indicate that between 2016 and 2020, the proportion of tablets with an on-label dosage increased from 38.5% to 67.3% and the presence of off-label contaminants decreased from 36.5% to 15.9%. However, even in 2021, about 1 in 3 tablets did not meet the quality criteria required in the European Union, either because the amount of sildenafil did not correspond to the labelling (which could lead to over- or under-dosing) or because the presence of pharmacologically active molecules was detected but not indicated on the label or packaging.
For public health reasons, the Health Directorate wishes to warn the public about buying from illegal websites selling falsified and unauthorised medicines in the European Union. The online sale of medicines in Luxembourg is reserved for over-the-counter medicines and only authorised to sites bearing an official logo guaranteeing the legality of the seller.
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