(Adds detail from EMA statement)
March 22 (Reuters) - Europe’s drugs regulator on Monday warned against the use of Merck & Co’s anti-parasite drug, ivermectin, for the treatment or prevention of COVID-19 outside clinical trials.
The European Medicines Agency’s (EMA) advice comes after similar warnings from the U.S. Food and Drugs Administration and Merck, which said its analysis of available data did not support the safety and efficacy of the drug for treating COVID-19.
The EMA said ivermectin is not approved for use against COVID-19 and it has not received any application for such use.
The EMA said that it has looked at the available evidence, where laboratory studies found that the drug could block replication of the virus but at much higher drug concentrations than those achieved with the currently authorised doses, and results from clinical trials were varied.
"Although ivermectin is generally well tolerated at doses authorised 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," the EMA said in a statement. (bit.ly/3f2jNwO)
Ivermectin tablets are approved for treating some parasitic worm infestations in the EU and for veterinary use for a wide range of animal species for internal and external parasites. (Reporting by Yadarisa Shabong in Bengaluru; Editing by Shailesh Kuber)