"You are not a horse. You are not a cow. Seriously, y’all. Stop it." This address sounds funny at first, but the United States Food and Drug Administration (FDA) did not know what else to do. In August 2021, the FDA made this appeal regarding ivermectin use in a tweet to the public.
The background: Several people in the USA had taken the drug ivermectin and poisoned themselves with it. On the same day, the health authority of the US state of Mississippi had reported: At least 70 percent of the previously received emergency calls due to poisoning were based on ingestion of ivermectin.
Ivermectin is the active ingredient in already approved medicines for humans and animals that are used against parasite infestations. The corresponding medicines are taken, for example, to fight threadworms in the body. They are applied to the skin to cure diseases such as scabies and rosacea, a skin inflammation on the face.
People all over the world are poisoning themselves with ivermectin
The increase in ivermectin poisonings is due to the fear of Covid-19 disease. Because all over the world, not only in the USA, the questionable information is circulating: Ivermectin could protect against catching the disease and increase the chances of recovery.
In Europe, too – for example in Austria – people poisoned themselves with ivermectin. In Styria, a woman ended up in intensive care due to a high dose of the active ingredient, Austrian broadcaster ORF reported. In Upper Austria, ivermectin drugs were bought in such high quantities that the supply ran out, according to the newspaper "Oberösterreichische Nachrichten".
There were indications of the effectiveness of ivermectin
Whether ivermectin can work against the coronavirus is in fact already being tested - like many other already approved drugs since the beginning of the corona pandemic. This is called "off-label use", which is a use apart from the actual purpose. Physicians can make such use in individual cases within the framework of their therapeutic freedom. One well-known example is the drug Remdesivir, originally developed as a treatment for Ebola. Meanwhile, the European Medicines Agency has also approved Remdesivir for certain forms of treatment as a drug against Covid-19, since it apparently contributes to the recovery of patients, and they must stay in hospital for a shorter time.
There have already been many studies on the use of ivermectin, and a possible effect against Covid-19 is being researched continuously. The reason that ivermectin was considered at all is that it was already known beforehand that the active ingredient can inhibit viruses. A promising laboratory study was published in June 2020. However, the trials there were conducted "in vitro". This means that ivermectin was not tested on patients in the study, but on cell cultures in the laboratory. The active ingredient was introduced into corona-infected test cells and was able to reduce the amount of viral RNA very significantly. "It is therefore justified to continue to investigate ivermectin for its potential benefit in humans", the team of researchers wrote at that time. However, one should not draw too far-reaching conclusions from this laboratory study alone, the medical journal "Pharmazeutische Zeitung" wrote, because the dose used was "far above that which is approved for humans".
Bavarian meta-study found no efficacy of ivermectin so far
In order to come to a clear conclusion, meta-studies are common practice in medicine and other sciences. In these studies, existing studies with high quality standards are examined together. The cumulative result is then usually considered particularly meaningful.
Such meta-studies also exist for ivermectin, and one of the best known comes from Bavaria. A team led by biologist Stephanie Weibel and physician Maria Popp from the University Hospital of Würzburg examined 14 studies with 1,678 participants. They published their meta-study in August 2021. Nine of these studies dealt with Covid-19 patients treated in hospital, four with outpatients and one study with prevention against corona infection.
Based on the current state of studies, the efficacy of ivermectin against Covid-19 is not proven, Weibel and Popp report: "We found no evidence to support the use of ivermectin for the treatment or prevention of Covid-19 infection, however, the existing evidence is limited." In response to a #Faktenfuchs enquiry, Weibel and Popp state: "In other words, we do not know whether ivermectin is helpful or not in the fight against Covid-19." And without a proven benefit, the possible negative side effects should be weighted higher, they say. Ivermectin should therefore only be used in well-designed scientific studies, Weibel and Popp recommend.
Research on ivermectin, however, is likely to enable scientists to make better statements soon. "Three larger studies (PRINCIPLE, COVID-OUT, and ACTIV) are on their way and will then hopefully lift the evidence and we will know for sure whether it helps or not", Weibel and Popp say to #Faktenfuchs. The PRINCIPLE trial has been running in the UK since June 2021 and is a large study with almost 8,000 participants so far, exploring treatment options against Covid-19 outside of a clinic. As soon as the results of this study are available, Weibel and Popp also want to use them to revise their meta-study.
Manufacturers and health authorities warn against unauthorised use of ivermectin
Meanwhile, the manufacturers and health authorities are warning against the unauthorised use of ivermectin. Following the incidents in Austria, the manufacturer Merck Sharp & Dome (MSD) spoke out. "In line with current medical recommendations, MSD is therefore clearly against the use in connection with COVID-19", the Austrian branch of the pharmaceutical company stated. Instead, people should rather get vaccinated: "MSD would like to conclude by stating that the C19 vaccination ranks first in the fight against the pandemic".
The Robert Koch-Institute, responsible for disease control in Germany, recommends as of October 20 the "use for therapy or prophylaxis only within the framework of controlled clinical studies". There is a "risk of serious toxicity in uncontrolled use". In plain language: If you use it on your own, you could poison yourself.
The FDA already warned in March 2021: severe side effects from independent use of ivermectin could include vomiting, diarrhoea, stomach pain, facial swelling, and liver problems such as hepatitis, up to and including hospitalisation.
There is currently no scientific evidence that ivermectin has a preventive effect against Covid-19 in humans or improves the chances of recovery. However, there is a risk of overdose and poisoning if ivermectin is taken.
Therefore, private individuals should not take ivermectin under any circumstances, warn the manufacturers and health authorities. Further studies are currently underway that promise new insights into the benefits or dangers of ivermectin in Covid-19 treatment.
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