Warning against the use of ivermectin for the treatment of COVID-19
The European Medicines Agency (EMA) has reviewed the evidence from laboratory studies, observational studies, clinical trials and meta-analyses and has concluded that the available data do not support the use of ivermectin for the treatment of COVID-19 outside of clinical trials.
Studies on ivermectin
Laboratory studies found that ivermectin can block replication of SARS-CoV-2 (the virus that causes COVID-19). However, the concentration required for this is much higher than currently approved doses allow. The picture of the clinical trials was mixed: some clinical trials showed no benefit, others showed potential benefit. Most of the studies examined by the EMA were small and had additional limitations, such as different doses or the use of additional medicines. The EMA therefore concluded that the evidence currently available is not sufficient to support the use of ivermectin for COVID-19 outside clinical trials.
Situation at EU level
In the EU, ivermectin medicines are not authorised for the treatment of COVID-19. The EMA also does not have an application for marketing authorisation for such use.
Situation in Austria
In Austria, ivermectin tablets are authorised in humans for the treatment of scabies (scabies mite) as well as parasitic worm infestations with strongyloidiasis (dwarf threadworms) and microfilaemia caused by Wuchereria bancrofti (tropical threadworms), and ivermectin skin preparations are authorised for the treatment of skin diseases in the context of papulopustular rosacea (copper acne). In the veterinary field, the authorisation covers the use against internal and external parasites in a variety of animal species.
Recommendation of the BASG
Ivermectin is generally well tolerated within the limits of the approved dosages. However, to achieve concentrations with antiviral activity against SARS-COV-2 in the lungs, much higher doses would be necessary, which in turn may lead to increased side effects. It cannot be ruled out that ivermectin has a toxic effect at a higher than approved dosage.
Thus, the use of ivermectin cannot be recommended at present (except in controlled clinical trials) for the prevention or treatment of COVID-19.
Warning from the European Medicines Agency (EMA)