For several years erectile stimulants have topped the statistics on medicinal products imported illegally into Switzerland. These prescription-only medicines are usually imported without the required medical assessment having been carried out beforehand. Many products don’t contain the substances listed on the label, and using these products can cause considerable damage to health. Analyses performed in the past have shown that the quality of these articles is frequently poor. Against this background, Swissmedic again inspected illegally imported and confiscated erectile stimulants in its own laboratory (OMCL) over a period of several weeks. This time the focus of the intensified action was products containing the active substance tadalafil. Almost half of the samples analysed were potentially harmful to health or of no use.
Swissmedic laboratory inspects illegal shipments of medicinal products in which tadalafil is the declared active substance
Since the start of 2019, the Federal Customs Administration and Swissmedic have been processing illegally imported medicinal products using what is known as a simplified procedure (see box). This enables a greater number of illegal shipments to be identified and seized.
This year, Swissmedic analysed seized products containing the declared active substance tadalafil in its own laboratory. Nearly half of the samples tested were of poor quality and did not contain what was declared on the packaging. In most cases the products were incorrectly dosed. One product contained just one eighth of the declared quantity, another two and a half times the stated dose. All six samples of a product with the additional name “Super Active” contained well below the correct dose. Seven products contained the wrong active substance (other PDE-5 inhibitors used to treat erectile dysfunction), one product was contaminated with other substances such as paracetamol.
Twelve per cent of all samples deliberately were massively overdosed. One tablet contained 80 mg of the active substance, corresponding to four times the maximum daily dose and 16 times the recommended quantity for daily use of low-dose tadalafil.
These overdoses are particularly worrying because the active substance is degraded relatively slowly in the body. Higher doses do not have a stronger effect, yet the risk of adverse reactions such as a fall in blood pressure or hypersensitivity reactions is greater. People with risk factors, in particular, may experience very serious events involving heart rhythm disturbances or even a heart attack. There is no medical reason for the overdosage, and it is presumably used only as an additional “sales argument”.
The detailed results are as follows: The following quality defects were found in 67 (or almost 48%) of the 140 products analysed:
- 52 products (37%) were incorrectly dosed
- 21 samples (15%) were heavily overdosed
- 8 products (almost 6%) contained almost no active substances
- 6 products (more than 4%) contained the wrong, i.e. other, chemical active substances that had not been declared.
Swissmedic advises against purchasing and using unauthorised medicines offered in advertisements, promotional e-mails, via the Internet or social media.
Using medicinal products purchased online from unknown sources can be harmful to health. Purchasing medicinal products from controlled sources is the only way of guaranteeing that their quality complies with requirements and that they pose no risk to health.
Simplified procedure leads to more seizures of illegal shipments
The major increase in seizures of illegally imported erectile stimulants is the result of intensified cooperation between the Federal Customs Administration and Swissmedic.
Since the start of 2019, illegally imported medicinal products have been processed using something known as a simplified procedure. The simplified procedure was tested in 2018 as part of a pilot project to stop illegal imports of erectile stimulants. The positive results – the new procedure enabled far more shipments to be seized – meant that the simplified procedure has been used since January 2019 for additional active substances in illegal imports of medicines.
In the simplified procedure, illegal shipments are seized and no procedural charges are imposed, provided the recipients agree to the goods being destroyed. As in the past, if illegal products are imported repeatedly, regular administrative proceedings subject to a fee are initiated, and criminal proceedings are initiated if large quantities of medicinal products are imported illegally.