No ivermectin for COVID, says EMA
The antihelmintic drug ivermectin should not be used for COVID-19 treatment outside of the clinical trial environment, according to a statement issued Monday by the European Medicines Agency (EMA).The European regulator’s statement parallels the position of the US Food and Drug Administration (FDA), which issued a 5 March update for consumers in response to “multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses.”
The consumer update reminded the public that ivermectin is not an FDA-approved treatment of preventative for COVID-19. FDA also warned consumers not to take veterinary formulations of medication.
In its statement, EMA acknowledged that high concentrations of ivermectin do block SAR-CoV-2 replication in vitro, but this effect was only seen at those extremely high concentrations. “Although ivermectin is generally well tolerated at doses authorized for other indications, side effects could increase with the much higher doses that would be needed to obtain concentrations of ivermectin in the lungs that are effective against the virus. Toxicity when ivermectin is used at higher than approved doses therefore cannot be excluded,” wrote the agency.
Merck, known as MSD outside the US and Canada, markets ivermectin as Stromectol for human use to treat onchocerciasis and intestinal strongyloidiasis. In a 4 February press statement Merck noted that its own analysis revealed “No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies,” as well as a lack of “meaningful evidence” for clinical activity or efficacy in patients.
Merck also cited a “concerning lack of safety data in the majority of studies.” Both EMA and FDA noted that clinical trials are ongoing examining the use of ivermectin for prophylaxis or treatment of COVID-19.
Ivermectin has been touted on videos and reported by some media outlets as a potential treatment or prophylaxis for COVID-19 for months.
EMA’s COVID-19 pandemic task force has endorsed EMA’s statement and incorporated the recommendations into its public health advice.
EMA