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www.fdanews.com/articles/201991-ema-joins-fda-in-cautioning-against-use-of-ivermectin-for-covid-19

EMA Joins FDA in Cautioning Against Use of Ivermectin for COVID-19

March 23, 2021

The European Medicines Agency (EMA) has advised against the use of Merck’s anti-parasitic drug Stromectol (ivermectin) for the prevention and treatment of COVID-19.

The EMA said it reviewed ivermectin after media reports touted the use of the drug against COVID-19. The agency scrutinized the latest evidence from lab studies, observational studies, clinical trials and meta-analyses, noting that most of the studies were small and had limitations, including different dosing regimens.

In some of the studies, there was no benefit shown while others reported a potential benefit. Some found that ivermectin could block replication of SARS-CoV-2, the virus that causes COVID-19, but only at much higher concentrations than those found in the currently authorized doses.

Although ivermectin — which is approved in the EU for parasitic worm infestations and skin conditions such as rosacea — 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 at such high doses can’t be excluded, the agency said.

The agency concluded that the currently available evidence is not sufficient to support the use of ivermectin in COVID-19 outside of a clinical trial.

In February, both Merck and the FDA cautioned against using ivermectin as a COVID-19 treatment. — Suz Redfearn